Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Surgical Wound

Pilonidal Sinus

Cysts

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

we excise the sinus tip then apply cyanoacrylate dressing and watch for healing

excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing

cyanoacrylate

wagih m ghnnam, MD

Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition

Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity. Incidence varies across countries and races .The cause remains controversial. Both congenital and acquired causes have been postulated Excision with a simple lay-open or performing marsupialization both result in a midline wound that takes several weeks to heal and there is a significant recurrence rate because of the open portal for hair insertion.so here we apply a new minimally invasive excision with cyanoacrylate dressing

Ghnnam Excision Technique for Pilonidal Sinus

Mansoura University

Wagih Mommtaz Ghnnam

Rare Diseases

Recurrence

Bowen's Disease

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

excision

Photodynamic therapy

Annette Verzijl, MD

The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses.

Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease

A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease

Erasmus Medical Center

Catharina Ziekenhuis Eindhoven

Drs. A. Verzijl

Neoplasm Metastasis

primary wound closure using a limberg flap

secondary wound healing

Christoph A Maurer, Prof Dr med

To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.

Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).

Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision

Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial

change for capacity for work at one year post-OP

Kantonsspital Liestal

Skin and Connective Tissue Diseases

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Basal Cell

Skin Diseases

All patients with basal cell carcinoma in a sun protected body site

All patients with basal cell carcinoma in a sun exposed body site

Surgical excision of the lesion and histopathology evaluation using Hematoxylin and Eosin stains

Excision

Abdulkarim Hasan, MD

Abdulkarim A Mohammed

Abdulkarim Hasan

A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.

Some cases may be tested for immunohistochemistry on the tissue block

Pathological Characteristics of Basal Cell Carcinoma

Basal Cell Carcinomas on Sun-protected Versus Sun-exposed Body Sites: a Clinicopathological Descriptive Study

Al-Azhar University

Laboratory coordinator

Clinical or histologic diagnosis of nodular BCC

Clinical or histologic diagnosis of superficial BCC

Curettage without subcutaneous tissue using a 7 mm ring curette and the "fountain-pen technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm.

Curettage

12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved.

Deep excision

Shave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved.

Shave excision

Curettage with a 7 mm ring curette with the "potato-peeler technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining.

Helmut Breuninger, M.D.

Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision.

This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.

1. First presentation of a patient with clinical or histopathological diagnosis of BCC
2. Study patient number, first and surname, date of birth and gender are listed in a distinct file.
3. Informed consent
4. Whole body screening for skin cancer
5. In- or exclusion of the patient. If the patient is excluded, no more data are obtained.
6. Recording of the following features in an electronic file:

   1. Number of BCCs
   2. Anatomic location

      * Lip
      * Eyelid
      * Ear
      * Nose
      * Other parts of the face
      * Scalp or neck
      * Trunk
      * Arm, hand, or shoulder
      * Leg, foot, or hip
   3. Position

      * Ventral or dorsal. If the tumor is located at the lateral margin of ventral and dorsal, it is considered ventral.
      * Right, left, midline
      * Distinct BCCs are numbered. To ensure future distinction of different tumors, numbering starts with the most up-right-ventral tumor and ends with the most down-left-dorsal one. Numbering continues with BCCs that appear later during the period of recruitment.
   4. Diameter in mm
7. In- or exclusion of the tumor
8. Photographs of the included BCCs
9. Randomization is performed by the Department of Biostatistics (distance to the Department of Dermatology = 1.7 km) with envelopes containing the assigned study arm. The study physician calls one of four staff members of the Department of Biostatistics and asks for randomization. The envelopes are not opened unless the electronic data file is completed by the study physician.
10. Disinfection
11. Local anesthesia
12. Surgery
13. Dressing
14. If histopathology discovers another BCC type than nodular or superficial or even another tumor than BCC, then the tumor is excluded.
15. Follow-up visit 3 and 6 months (+/- 30 days) after the operation. In BCCs that had to be operated in \>1 step, the day of the follow-up visit refers to the initial operation.
16. In case of clinical suspicion of recurrence of BCC a punch biopsy is taken. If the biopsy confirms recurrence, the endpoint is achieved.
17. If BCCs must be added to a patient during the recruitment period, follow-up visits always refer to the latest BCC.
18. If the patient visits our department not within the defined follow-up period, the appointment is not recorded (except confirmation of recurrence).
19. Patients who provide no feedback receive phone calls.
20. If a patient or a private practitioner suspect a recurrence of BCC beyond a defined follow-up period, of course, the patient is invited as early as possible to our department, where a biopsy will be taken.
21. The patient receives a letter containing a list of the BCCs treated within the study. The private practitioner is to be visited with the list after 12, 24, and 36 months (+/- 30 days) referring to the last operation within the recruitment period. The letter contains a questionnaire about scar size and suspicion of recurrence of BCC. The practitioner or the patient return the questionnaire with the answers to our department. If recurrence is suspected we take a biopsy.
22. When follow-up is closed for an individual patient, the reason is recorded:

    1. Planned end of follow-up after 48 months.
    2. Patient has moved.
    3. Death (date of death).
    4. Consent withdrawn.
    5. Patient has become meanwhile so ill or high-maintenance that no more follow-up visits can be planned.
    6. Recurrence of all of the patient's BCCs.
23. Statistic evaluation is based on an intention-to-treat-analysis.
24. The trial is designed to prove the equivalence of treatment modalities. A statistic test is used for evaluation, including the Kaplan-Meier-method. When all 4 study arms contain 116 BCCs, a 2-group-test on the equivalence of ratios with a 1-sided significance level of 0.05 will have a power of 80% to disprove the null hypothesis. The null hypothesis is that standard and test method are not equivalent (ratio difference delta T - delta S ≥ 0.15). Then the alternative hypothesis is more probable, meaning that the ratios in both groups are equivalent supposed that the expected ratio difference is 0.07 and the ratio within the standard group is 0.03 (according to an expected recurrence rate of 3% in the surgical excision study arm).

Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

University Hospital Tuebingen

Professor Helmut Breuninger, MD

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

In the experimental group pIONM will be performed intraoperatively. For the implementation of pIONM, a special device, that allows simultaneous monitoring of sphincter signals and bladder manometry, will be introduced. This device will employ the placement of a bipolar electrode in the internal and external anal sphincter. Moreover, another electrode will be placed on the surrounding tissues. For bladder manometry, the catheter will be connected to the pressure sensor, and subsequently to the pIONM monitor. Intraoperatively, depending on the approach (open or laparoscopic), the respective bipolar stimulator will be used.

Prior to the initiation of pIONM, urinary bladder will be drained and filled with 200 ml R/L. The pIONM parameters will be the following: 1-25 milliampere current, 30 Hz frequency and 200 μs monophasic pulses.

In the control group pIONM will not be performed intraoperatively

Pelvic Intraoperative Neuromonitoring (pIONM) allows mapping of the pelvic autonomous plexus during total mesorectal excision (TME).

Pelvic Intraoperative Neuromonitoring

Konstantinos Tepetes, Prof

Konstantinos Perivoliotis, MD

Anastasios Manolakis, PhD

Michael Samarinas, PhD

Aikaterini Tsiogga, MSc

The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.

The introduction of Total Mesorectal Excision (TME) resulted to the improvement of the overall survival and local recurrence rates of rectal cancer patients. However, the associated urogenital and anorectal functional deficit has a significant effect on the postoperative quality of life of the patient. More specifically, the postoperative rates of urogenital and sexual dysfunction that have been reported in the various series, are estimated at the levels of 70% and 90%, respectively. Additionally, TME is associated with the development of the low anterior syndrome (LARS). LARS is characterized by the onset of fecal incontinence, due to injury in the autonomic nerve plexuses that innervate the internal anal sphincter (IAS); who in turn is responsible for the 52-85% anal resting tone. According to a recent study, 38.8% and 33.7% of patients with normal preoperative urogenital function, developed postoperative stool and urine incontinence, respectively.

It becomes apparent that the incidence rates of these complications vary between the various series, mainly due to their small sample size, the lack of comparative data, the short follow up period, the use of non-validated tools and their retrospective design. Several predictive factors of these adverse events have been suggested in the literature, including old age, tumors located less than 12 cm from the anal verge, preoperative radiotherapy and injury to the pelvic autonomous nerves.

The clinical and functional anatomy of the pelvis are quite complex. The inferior hypogastric plexus is formed by the parasympathetic pelvic nerves, deriving from the I2-I4 and the sympathetic hypogastric nerve. It is a neural anatomic structure that carries organ-specific nerve fibers. Visual identification of the plexus is quite difficult, for various reasons, including the complexity of the nerve distribution, the narrow pelvis, the voluminous mesorectum, obesity, previous pelvic operations, neoadjuvant radiotherapy, locally advanced tumors, intraoperative bleeding and the extensive use of diathermy. According to the current literature, identification of the autonomous pelvic plexus is achievable in 72% of cases, whereas partial localization is possible only in 10.7% of patients.

Theoretically, intraoperative neuromonitoring of the pelvic autonomous nerves (pIONM), could quantify intraoperative nerve injuries, while in parallel, contribute to the improvement of the patients' postoperative quality of life. Several pIONM techniques have been described, including intra-urethral and intra-vesical pressure measurements. However, it was found that intermittent neuromonitoring objectifies the macroscopic integrity assessment of the sacral plexus. Recently, a promising technique, based on the simultaneous electromyography of the IAS and bladder manometry was developed, with encouraging results. During pIONM, the surgeon delivers electric stimuli to the autonomic nerve structures through a hand-held stimulator. At the same time, electromyogram changes of the IAS and the external anal sphincter (EAS), alongside intravesical pressure gradients are assessed.

Intraoperative neuromonitoring has been evaluated in several experimental studies. In a recent study, intraoperative simulation of the inferior hypogastric plexus with a bipolar stimulator resulted to the appearance of a measurable and repeatable electromyographic signal from the IAS.

Simultaneous signal processing from the IAS and urinary bladder, improves the, overall, diagnostic accuracy of these techniques. Stabilization of the electrodes outside the surgical field, has been, also, suggested by some researchers. Additionally, experimental studies evaluated the role of pIONM in the minimal invasive TME.

Moreover, the effectiveness of this technique has been a research subject in multiple clinical trials. In another study, where 85 patients underwent TME, after logistic regression, no use of pIONM and neoadjuvant radiotherapy, were identified as independent prognostic factors of postoperative urogenital deficit. Furthermore, the use of pIONM, was associated with a 100% sensitivity and a 96% specificity for the postoperative development of urogenital and anorectal functional complications.

The application of pIONM has been also suggested in the laparoscopic and robotic TME, using specially designed stimulators. In another trial, preservation of the plexus was achieved in 51.7% of patients submitted to a laparoscopic low anterior resection for rectal cancer. During one year follow-up, patients receiving pIONM, displayed a superiority in terms of postoperative urogenital function, as assessed by the IIEF, IPSS and FSFI questionnaires.

The study will employ a prospective, parallel randomized-controlled design

The patient will be blinded regarding the allocation group. Blinding will not exist at the level of the surgeon, the anaesthesiologist, and the investigator responsible for the data recording

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

Change in the quality of life of the patient, at 3 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome

The total operative time will be recorded. Measurement unit: minutes

The total intraoperative blood loss volume will be recorded. Measurement unit: mL

Postoperative time that the patient can be safely discharged. Measurement unit: hours. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding

Occurrence of postoperative complications (based on Clavien-Dindo classification). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of negative resection margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of local recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Urodynamic assessment. Evaluation of bladder capacity. Measurement unit: ml

Urodynamic assessment. Evaluation of bladder compliance. Measurement unit: ml/cm H2O

Urodynamic assessment. Evaluation of detrusor pressure at maximum flow. Measurement unit: cm H2O

Urodynamic assessment. Evaluation of maximum urinary flow rate. Measurement unit: ml/s

Urodynamic assessment. Evaluation of voiding volume. Measurement unit: ml

Urodynamic assessment. Evaluation of post-void residual. Measurement unit: ml

High-resolution Anorectal Manometry assessment. Evaluation of anal canal resting phase pressure. Measurement unit: mmHg

High-resolution Anorectal Manometry assessment. Evaluation of sphincter zone length. Measurement unit: cm

High-resolution Anorectal Manometry assessment. Evaluation of short squeeze (5sec) pressure. Measurement unit: mmHg

High-resolution Anorectal Manometry assessment. Evaluation of long squeeze (30sec) pressure. Measurement unit: mmHg

High-resolution Anorectal Manometry assessment. Evaluation of cough test (0 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

High-resolution Anorectal Manometry assessment. Evaluation of push test (0 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

High-resolution Anorectal Manometry assessment. Evaluation of rectoanal inhibitory reflex (RAIR) test (20 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Difference in the quality of life of the patient, at 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome

Difference in the erectile function of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the International Index of Erectile Function (IIEF) questionnaire IIEF: International Index of Erectile Function Minimum Value: 0 Maximum Value: 5 Higher scores indicate a better outcome

Difference in the sexual function of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Female Sexual Function Index (FSFI) questionnaire FSFI: Female Sexual Function Index Minimum Value: 2 Maximum Value: 36 Higher scores indicate a better outcome

Difference in the prostate symptoms of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the International Prostate Symptom Score (IPSS) questionnaire IPSS: International Prostate Symptom Score Minimum Value: 0 Maximum Value: 35 Higher scores indicate a worse outcome

Difference in the low anterior syndrome symptoms of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Low Anterior Resection Syndrome (LARS) questionnaire LARS: Low Anterior Resection Syndrome Minimum Value: 0 Maximum Value: 42 Higher scores indicate a worse outcome

General Hospital of Larissa

University of Thessaly

Larissa University Hospital

Perivoliotis Konstantinos, Principal Investigator

Colonic Neoplasms

Colonic Diseases

Herbal and Botanical

Cola

In laparoscopic right colectomy subgroup, the patient will be placed in a lithotomy position. Entrance in the peritoneal cavity will be completed via the open Hasson method. Overall, 4 ports will be used: 10mm at the umbilicus for optical entry, 12mm in the left midclavicular line below the umbilicus as the main working port, 5mm at the McBurney point, and 5mm between the umbilicus and the xiphoid process. Dissection of the peritoneal fold, under the terminal ileum, will be performed based on the medial to lateral approach. Similar to the open approach, the ileocolic vessels, as well as the right branches of the middle colic will be ligated at their origin for cecal and proximal ascending tumors. For hepatic flexure cancers, the medial colic vessels will be ligated. The ileocolic anastomosis will be completed either intracorporeally or extracorporeally, using staples or sutures.

In the open right colectomy group, the operation will start with a midline incision and dissection based on the lateral to medial approach. The lateral peritoneal fold along Toldt's line will be incised and the ascending colon will be mobilized from the retroperitoneum according to the embryological dissection planes. Dissection will continue until the anterior surface of the superior mesenteric vessels at the third duodenal part. Ileocolic and right colic vessels will be ligated at their origins. For hepatic flexure tumors, the middle colic vessels will be also ligated at their origin. The ileocolic anastomosis will be performed using an automatic stapler. The anastomosis will be completed either with staples or sutures.

Resection of the ascending colon via a laparoscopic approach, adhering to the CME principles

Laparoscopic right colectomy

Resection of the ascending colon via an open approach, adhering to the CME principles

Open right colectomy

George Tzovaras, Prof

George Tzovaras, Professor

Ioannis Baloyiannis, Prof

The purpose of this research protocol is to compare open versus laparoscopic right colectomy (according to the CME technique of complete mesocolic excision) for right colon cancer. This study will be designed as a prospective randomized controlled trial. The comparison of the two techniques will include endpoints regarding the quality characteristics of the specimens and the oncological results. In addition, the effectiveness of the two methods will be evaluated in terms of the early and late postoperative period.

Colorectal cancer is the third and second most common malignancy in male and female patients, respectively, with up to 1.8 million new cases and 860,000 deaths per year.

Anterior resection with total mesorectal excision (TME) was first proposed by Heald in 1982 and is currently the gold standard surgical technique for middle and lower rectal cancer. Heald considered that the metastatic spread of the tumor occurs through micro-implantations in the lymph node network of the mesorectum, and much less through horizontal intramural infiltration, and thus defined rectal resection margins at 5cm or even 2cm for well-differentiated neoplasms. Therefore, he suggested that mesorectum displays a greater risk for micro-metastatic disease and should be removed en-bloc with intact resection margins.

Similarly in 2009, Hohenberger proposed the complete mesocolon excision (CME) concept for the treatment of colon cancer, based on the respective embryological development anatomical planes. After analyzing a large cohort of patients, he concluded that this operation type leads to a significant reduction in the local recurrence and an increase in the overall survival rates.

Hohenberger proposed open CME as the optimal surgical technique for colon cancer, under the premise that the following principles are met:

* Dissection of Toldt's fascia and mesocolon preservation
* Central vascular ligation
* Extensive locoregional lymph node dissection CME technique, as described by Hohenberger in 2008, is an extension of Heald's TME and it is based on the sharp dissection and separation of the visceral fascia that surrounds the colon from the parietal fascia. The aim is to fully mobilize the colon and the corresponding mesocolon, which is surrounded bilaterally by sheets of visceral fascia. This ensures the complete resection of the tumor and the corresponding lymph nodes. At the same time, central vascular ligation allows the dissection of the apical lymph nodes.

There are three resection planes: the mesocolic, intramesocolic and muscularis propria plane. The ideal resection plane is the mesocolic, in which the colon is removed, along with the entire mesocolon and all the venous and lymphatic tissue, without violating the visceral fascia. Surgical specimens categorized into either of the other two resection planes are associated with reduced R0 resection rates and with reduced overall survival. Characteristically, the muscularis propria resection plane has been associated with up to 15% reduced survival rate compared to the mesocolic plane.

There are specific morphometric characteristics of surgical specimens that are used to assess their quality. These include tumor and proximal colon high vascular ligation distance, number of lymph nodes, length of resected small bowel and colon, and total area of the mesocolon. These characteristics are directly related to the number of harvested lymph nodes and, therefore, to overall survival.

According to initial results, CME specimens were larger in size, contained a longer length of colon, a larger mesenteric surface and a greater number of lymph nodes compared to the standard colectomy specimens. In addition, a greater distance of the tumor from the resection margins was highlighted. Specifically for right colon cancers, recent publications have shown that CME can achieve better morphometric specimen characteristics and a greater number of lymph nodes. In a recent randomized study, Di Buono et al. compared the completion of CME or not, during laparoscopic right colectomy. A significant difference was found in favor of CME, regarding the specimen length and the lymph node harvest.

Despite these, the literature evidence regarding the morphological and qualitative characteristics of laparoscopic and open CME specimens are still inconclusive. Specifically for right colectomies, in the comparative study by Gouvas et al., it was observed that the percentage of the mesocolic resection level was 100% in open colectomy, in contrast to 85.7% in the laparoscopic approach. However, this difference was not statistically significant. In a retrospective study by Ali Koc et al., no difference was found between open and laparoscopic CME in terms of specimen length, R0 resection rate and number of resected lymph nodes. A recent publication by Ali Zedan et al., argued that open CME is associated with longer specimens, larger mesenteric area, and increased resection margins. Another interesting finding was that the number of lymph nodes and the distance of the ligation site were greater in the laparoscopic CME group. However, the meta-analysis by Anania et al. failed to validate any difference between the two methods in the total number of lymph nodes. Finally, a comparative analysis of our own series of patients did not show superiority of one technique over the other in terms of resection level, specimen length and number of lymph nodes.

Additional qualitative characteristics of a colon cancer operation include operative time, intraoperative blood loss, time of bowel function recovery, length of postoperative hospital stay, postoperative complications, as well as overall survival and local recurrence rate. In a recent meta-analysis by Anania et al. applying the principles of CME to right colectomies did not affect the rates of postoperative leaks, bleeding, overall complications, and reoperations. However, CME right colectomy was associated with optimal results in terms of 3-year overall survival and 5-year disease-free survival.

Regarding the application of laparoscopy principles to CME colectomies, previous studies have confirmed that it is a technique with optimal results, such as faster postoperative recovery, shorter hospital stay, and lower morbidity. There is agreement between studies regarding the perioperative benefits of laparoscopic CME right colectomy versus the open method. According to Huang et al., the length of operative time between the two techniques was comparable. Laparoscopic right colectomy was associated with significantly lower intraoperative blood loss and faster initiation of feeding. In addition, these patients were discharged earlier compared to their counterparts in the open colectomy group. Moreover, no differences were observed in complication and local recurrence rates. These findings were also confirmed by the comparative study of Sheng et al., where the application of the minimally invasive technique resulted in lower levels of postoperative pain, and faster recovery. Accordingly, Shin et al., applying propensity score analysis, to remove possible confounding factors, in a sample of 2249 right colectomies and found that the technique is an independent predictor for 5-year disease-free survival. Pooled data from Anania et al., confirmed the superiority of laparoscopic CME in the rates of postoperative complications, intraoperative bleeding, and length of hospital stay. These are also in accordance with our own experience, where a significant benefit of the laparoscopic approach was shown in the duration of hospitalization and septic complications, at the cost of prolonged surgical time.

There will be no blindness at the level of the patient, the treating physicians (surgeon, anesthesiologist) and the researcher who will record the data.

Laparoscopic Versus Open Right Colectomy for Right Colon Cancer

Comparison of Laparoscopic Versus Open Right Colectomy for Right Colon Cancer, According to the Complete Mesocolic Excision (CME) Principles: a Prospective Randomized Controlled Trial

Occurrence of Mesocolic Resection Plane. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Open Conversion. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Stapled or Handsewn Anastomosis. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Intraoperative Transfusion. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Postoperative Complication. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Postoperative time until the recovery of bowel function is achieved. Measurement unit: days

Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria

Occurrence of Negative Resection Margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Local Recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Disease Free Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Occurrence of Overall Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.

EPSiT

Surgery to remove all affected tissue, followed by wound closure.

Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.

Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use.

Allocation ratio 2:1

Pilonidal Excision Versus Endoscopic Surgery

St Helens & Knowsley Teaching Hospitals NHS Trust

Behaviors and Mental Disorders

Anxiety Disorders

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

Clinical surveillance standard of care without Melanoma Surveillance Photography.

Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

2D or 3D Melanoma Surveillance Photography

Victoria Mar

This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.

It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.

The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.

The secondary aims are to:

1. Evaluate whether MSP:

   1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
   2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
   3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).

Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:

1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.

The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.

Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients

To estimate the benefit of MSP in high risk patients prior to a melanoma diagnosis, amongst participants who would have been classified as 'high risk' at the time of their primary melanoma, this sub-study will compare:

i) Breslow thickness of the primary melanoma at entry into this trial, and ii) Biopsy rates prior to diagnosis

Approximately 100 paired sets of 3D surveillance and digital dermoscopy images (baseline and follow-up) taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists; all 100 pairs sent to all 10 doctors) for teledermatology assessment. The study doctors will assess the images with respect to whether they have a melonama present or not. Images will be selected randomly from amongst patients accrued to the main study for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology (gold standard) during the trial. This substudy will not affect patient care but will assess diagnostic performance (sensitivity and specificity) in the teledermatology setting compared to the en-face clinical setting in order to validate the use of telediagnosis in routine care.

The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.

Standard health economic cost-effectiveness measures.

Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).

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Laparoscopic Versus Open Right Colectomy for Right Colon Cancer	NCT05713903	Colon Cancer	Laparoscopic ri... Open right cole...	18 Years - 90 Years	Larissa University Hospital
Pilonidal Excision Versus Endoscopic Surgery	NCT03923621	Pilonidal Sinus	EPSiT Excision	16 Years -	St Helens & Knowsley Teaching Hospitals NHS Trust
Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas	NCT00515970	Carcinoma, Basa...	Curettage Deep excision Shave excision Curettage	-	University Hospital Tuebingen
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients	NCT04385732	Melanoma Skin Cancer Anxiety and Fea...	2D or 3D Melano...	18 Years -	Melanoma and Skin Cancer Trials Limited
Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas	NCT00515970	Carcinoma, Basa...	Curettage Deep excision Shave excision Curettage	-	University Hospital Tuebingen
Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease	NCT00472706	Bowen's Disease	excision Photodynamic th...	18 Years -	Catharina Ziekenhuis Eindhoven

Spots Global Cancer Trial Database for excision

Every month we try and update this database with for excision cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for excision

Every month we try and update this database with for excision cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for excision cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.