Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Neoplastic Cells, Circulating

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasm Metastasis

Neoplastic Processes

During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.

During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.

Vein ligation first

Artery ligation first

Lunxu Liu, M.D.,Ph.D.

The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.

Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival. Handling the tumor during a surgery may promote the release of CTCs into the bloodstream. Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified. This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.

Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer

Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial

The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest

From the date of recruitment until the date of progression of lung cancer assessed up to 36 months

The length of patients staying in hospital from the date of checking in to the date of checking out

Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.

West China Hospital

Professor

Ear, Nose, and Throat Diseases

Death

Pilonidal Sinus

Paranasal Sinus Diseases

Seroma

Cysts

Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision).

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.

Group 2 were treated with the standard Karydakis technique.

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.

Asymmetric Primary Closure and Additional Skin Excision Technique

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method

Standard Karydakis technique.

The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.

In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.

In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.

In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Asymmetric Primary Closure and Additional Skin Excision Technique.

A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.

The study has been completed. The datas will be shared as an article

wound dehiscence, formation of seroma, hematoma, wound infection

Siverek Devlet Hastanesi

General surgeon

Wounds and Injuries

Hernia

Surgical Wound

Incisional Hernia

Pathological Conditions, Anatomical

Postoperative Complications

Abdominal cavity will be closed by a single layer of 2 continuous sutures beginning on the opposite ends of the wound towards the median line and involving peritoneum, transversalis fascia, posterior and anterior layer of rectus abdominis muscle fascia and, in case of incisions beyond the lateral border of rectus abdominis muscle, also the oblique abdominal muscles fascia.

Abdominal cavity will be closed with two separate layers of continuous sutures. The first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia. In case of incisions not exceeding the lateral border of rectus abdominis muscle, the second layer will involve only the anterior layer of the rectus abdominis muscle fascia. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer will include internal oblique abdominal muscle fascia, external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.

Mass closure technique

he first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia closed with 2 continuous sutures beginning at both ends of the wound. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer of the continuous suture will start at the lateral border of rectus abdominis muscle, process laterally to the lateral end of the wound involving internal oblique abdominal muscle fascia. Subsequently, the suture will be led out on the anterior surface of the external oblique abdominal muscle, put through by the created loop in the medial direction and processed medially to close the external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.

Layered closure technique

Michał Grąt, MD, PhD

RESEARCH PROJECT OBJECTIVES The aim of this planned study is to evaluate factors, with particular reference to surgical technique of abdominal closure, accumulation of advanced glycation end products, and collagen content in the transversalis fascia, that are associated with the development of incisional hernias after transverse epigastric incisions in patients operated due to malignant tumors.

RESEARCH PROJECT METHODOLOGY:

The study is designed as prospective and is planned to include 392 patients undergoing abdominal surgery due to malignant tumors of the alimentary system performed through transverse incisions in the epigastrium. Primary end-point of the study is defined as the occurrence of burst abdomen during immediate postoperative period or incisional hernia over 2 year postoperative follow-up. Assessment of the association between the type of surgical technique and development of hernia will be based on comparison of mass (1 layer) continuous suture and layered (2 layers) continuous suture using slowly absorbable material and applying suture to wound length ratio of more than 4. Type of the utilized surgical technique will be based on randomization. The method of abdominal closure will remain unknown for patients and investigators assessing the presence of incisional hernias. Assessment of overall collagen content and type I to type III ratio will be performed by obtaining a fragment of tissue during operation, preparation of formalin-fixed and paraffin embedded blocks, cutting of 4-micrometer thick sections, staining with picrosirius red and immunohistochemical procedures. Images will be analyzed with dedicated computer software. Accumulation of advanced glycation end products will be evaluated indirectly by measuring skin autofluorescence utilizing a method based on the use of photodiodes. Postoperative follow-up will include the period of postoperative hospitalization and two additional control visits at 1 and 2 years after the operation. Assessment of the presence of incisional hernia will comprise clinical examination, ultrasonographical study, and analysis of images from other available radiological studies. Irrespective of the primary end-point, additional analyses will be performed concerning associations between evaluated factors and occurrence of burst abdomen and the impact of incisional hernia on patients quality of life using the EORTC QLQ C-30 questionnaires. Statistical analyses will, among other, include Kaplan-Meier method, log-rank test, Cox proportional hazards regression and logistic regression

The technique comprising continuous suture and mass closure will be compared to the technique 2 separate layers of continuous sutures.

Patients will be randomly assigned to one of the two techniques of abdominal closure during the operative procedure and after its main part has been completed, just before the beginning of closure of the abdominal cavity. Randomization will be performed in a 1:1 ratio and in blocks of 20 patients.

Neither the patients included in the study nor the investigators assessing the presence of incisional hernia during follow-up visits will be aware of the type of surgical technique used for abdominal closure (double-blinded study). Only the professionals present in the operating room during surgical procedure, including operator, assistants, anesthesiologist, and nurses, will be aware of the type of assigned intervention.

Risk Factors for Development of Incisional Hernia in Transverse Incisions

Study on the Risk of Incisional Hernia Development Following Transverse Epigastric Incisions in Patients Operated for Malignant Tumors

Development of burst abdomen in the immediate postoperative period (until discharge from hospital) or incisional hernia over a 2-year follow-up period (combined end-point). The follow-up protocol used for the assessment of incisional hernias at discharge from hospital and two control visits at 1 and 2 years postoperatively.

Quality of life assessed in EORTC QLQ-C30 questionnaire

surgical site infections, defined and classified according to the CDC (Centers for Disease Control) recommendations

Complications of grade III or higher according to Clavien-Dindo classification

Duration of postoperative hospitalization in days

National Science Centre, Poland

Medical University of Warsaw

Digestive System Diseases

Colorectal Neoplasms

Diverticulitis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Diverticulum

Diverticular Diseases

Gastroenteritis

Cruciate incision in the abdominal wall fascia

Mesh enforcement and then cruciate incision in the abdominal wall fascia

Cruciate incision

Circular incision

Mesh enforced cruciate incision

Eva Angenete, M.D., Ph.D.

An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included.

The three groups for randomization are:

A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months.

Colostomy formation has been a standard surgical procedure for more than 100 years. Initially the quality of life for stoma patients was all but good, as the appliances to collect the feces were cumbersome, smelly and did not ensure non-leakage. As late as in the 60-ies bandages were still primitive(1). Gradually these problems have decreased as techniques for bandages have improved. A well functioning colostomy may in itself not negatively affect the patient's Quality of Life (QoL)(2), although thorough information and support from stoma care nurses is of utmost importance (3). However, this can only be said if the stoma is well functioning and if the complications are kept to a minimum. The complication rate after stoma formation is still considerable, with figures of 21-70% (4, 5) and studies have shown that adequate height; type of stoma, BMI, emergency surgery and gender may be of importance in reducing the risk of complications both in the short and long-term (6-8).

The surgical technique of stoma formation is only partly evidence based. There are few studies directed at technical details about stoma construction and their future impact on stoma function, apart from the importance of the stoma height (6). One study has tested to standardize the skin incision to 2/3rds of the width of the bowel (9), although the actual impact of this on the functional outcome of the stoma was not presented.. In the surgical literature a cruciate incision in the fascia and extraction of the bowel through a hole sufficient in size is a short description of the surgical technique (10). In clinical practice sufficient size of the hole has often been equal to "two fingers-width", is commonly used, which refers to the width of the surgeon's fingers, a fairly inexact measurement. A pilot study from Sahlgrenska University Hospital has found that this clinical practice for the most part results in a skin incision diameter of 50% of the bowel width.

There have been discussions regarding the placement of the stoma and effects on hernia incidence, whether in the obliquous muscle or the rectus abdominis (11) or if the bowel should take an extraperitoneal route (ad modum Goligher) or not (12). No studies have been sufficient in design or size to thoroughly answer the question.

Parastomal hernia is a long-term complication that is common, in the literature figures up to almost 50% have been reported (13, 14). Attempts to reduce the rates of parastomal hernias have been made in the last few years with a placement of a mesh, at the construction of the stoma, (15-19). This practice has not been universally accepted, in part due to a hesitance in the surgical society because of the risk of infections with foreign body material, and partly due to that most studies are underpowered for their main outcome variable. Another suggestion for the basic construction of the stoma has been to make a circular incision in the fascia instead of a cruciate, but this has not been documented in any studies. It has been described in conjunction with use of circular stapling devices in the skin, no hernias were found, however the patient numbers were small (20). It is apparent that further studies are most welcome.

The evaluation of parastomal hernias has been discussed. Janes et al. used clinical examination in their studies (16, 17), and confirmed in a later study that the concurrence with a CT-verified parastomal hernia was (21) sufficient if performed in a prone position. Another recent study found that results from a CT-scan was not correlated with patient symptoms (22). Other studies have evaluated the use of ultrasound and found it feasible (23). The conclusion must be that evaluation of parastomal hernias may be difficult and must be standardized in a study.

The hypothesis to be tested in this study is that a circular incision or mesh enforced cruciate incision in the abdominal wall fascia with a diameter of 50% of the width of the patients left colon results carries less risk of parastomal herniation than a cruciate incision where the each of the arms measure 1/2 of the diameter of the patients left colon.

The aim of this trial is to compare the parastomal hernia formation within 12 months after stoma surgery between circular, mesh enforced cruciate and cruciate incision.

A Randomized Trial on the Technical Aspects of Stoma Construction.

Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial

The frequency of stoma hernia at 12 months measured either by clinical examination or CT scan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer	NCT03436329	Lung Cancer Surgery Circulating Tum...	Vein ligation f... Artery ligation...	18 Years - 80 Years	West China Hospital
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer	NCT03436329	Lung Cancer Surgery Circulating Tum...	Vein ligation f... Artery ligation...	18 Years - 80 Years	West China Hospital
Asymmetric Primary Closure and Additional Skin Excision Technique.	NCT03424057	Pilonidal Sinus Pilonidal Disea... Surgical Techni...	Asymmetric Prim... Standard Karyda...	18 Years - 65 Years	Siverek Devlet Hastanesi
Asymmetric Primary Closure and Additional Skin Excision Technique.	NCT03424057	Pilonidal Sinus Pilonidal Disea... Surgical Techni...	Asymmetric Prim... Standard Karyda...	18 Years - 65 Years	Siverek Devlet Hastanesi
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer	NCT03436329	Lung Cancer Surgery Circulating Tum...	Vein ligation f... Artery ligation...	18 Years - 80 Years	West China Hospital
Risk Factors for Development of Incisional Hernia in Transverse Incisions	NCT03561727	Incisional Hern... Malignancy	Mass closure te... Layered closure...	18 Years -	Medical University of Warsaw
Risk Factors for Development of Incisional Hernia in Transverse Incisions	NCT03561727	Incisional Hern... Malignancy	Mass closure te... Layered closure...	18 Years -	Medical University of Warsaw
A Randomized Trial on the Technical Aspects of Stoma Construction.	NCT01694238	Colostomy Colorectal Neop... Diverticulitis	Cruciate incisi... Circular incisi... Mesh enforced c...	-	Sahlgrenska University Hospital, Sweden
A Randomized Trial on the Technical Aspects of Stoma Construction.	NCT01694238	Colostomy Colorectal Neop... Diverticulitis	Cruciate incisi... Circular incisi... Mesh enforced c...	-	Sahlgrenska University Hospital, Sweden
A Randomized Trial on the Technical Aspects of Stoma Construction.	NCT01694238	Colostomy Colorectal Neop... Diverticulitis	Cruciate incisi... Circular incisi... Mesh enforced c...	-	Sahlgrenska University Hospital, Sweden

Spots Global Cancer Trial Database for surgical technique