Neoplasms

All Conditions

Wounds and Injuries

Digestive System Diseases

Adenocarcinoma

Colonic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Colonic Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using a running suture type with Monofix, one of the barbed sutures.

In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using an interrupted suture type with PDS-II, one of the monofilament sutures.

Monofix

This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.

The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery

Exploratory Clinical Trial for Evaluating the Safety and Efficacy of MONOFIX® on Fascial Closure of Mid-line Wound for Patients With Colon Cancer Underwent Minimally Invasive Surgery: Single-center, Non-blinded, and Single-arm Design

In cases where microorganisms were identified in the wound culture results.

In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan.

In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment.

Samsung Medical Center

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy.

Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study

robotic assisted radical prostatectomy

Irene Fita Esteban

Anna Ibañez Jimenez

Miguel Sánchez Encinas, Dr.

Carlos Hernandez Rios, Dr.

Dr. Miguel Sánchez Encinas, Dr.

The aim of this observational study is to show the superiority of the bidirectional barbed suture (Symmcora® Longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared to the available literature data, without an increase in the complication rate.

Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy

Prospective, Multicenter, Single-arm Study on the Performance of Symmcora® Long-term Bidirectional Barbed Suture for Vesicourethral Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy.

Handling of the suture is assessed for every participating surgeon once after inclusion of the last patient. Handling is measured in 16 dimensions + overall impression with five evaluation levels (excellent, very good, good, satisfied, poor)

Handling of the suture is assessed for every participating surgeon once after inclusion of the last patient. Handling is measured in 13 dimensions + overall impression with five evaluation levels (excellent, very good, good, satisfied, poor)

Time to perform the vesicourethral anastomosis using a stopwatch. Time starts when the needle passes the first time the tissue and ends after completion of the anastomosis. Completion of the anastomosis is defined by the last cut of the thread.

Blood loss is estimated by the amount of intraoperatively needed transfusion

Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag

Urinary retention is an inability to completely empty the bladder

A urogenital fistula is an abnormal tract that exists between the urinary tract and bladder, ureters, or urethra. A urogenital fistula can occur between any of the organs and structures of the pelvic region. A fistula allows urine to continually exit through and out the urogenital tract.

Cumulative rate of patients with a complication related to the bladder neck contracture

Cumulative rate of patients with a complication related to urinary stone formation

Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)

Time to perform the intervention from first cut to last cut of the last thread. The time is measured using a stopwatch.

Time to perform the modified Rocco stitch: After prostate extirpation, the free edge of the Denonvillier fascia is approximated to the posterior rhabdosphincter/median raphe using a running suture. Then, the Denonvilliers' fascia is fixated to the posterior wall of the bladder, which reduces tension in the anastomosis and provides pelvic support to the bladder neck. The time is measured using a stopwatch.

Number of days from surgery till patient is discharged from hospital

Number of days from surgery till catheter was finally removed

Days after catheter was finally removed to complete continence

The 24-hour pad test is used as an objective diagnostic method for the assessment of post prostatectomy stress urinary incontinence. Pads are weighed before and after use and the amount of urine is measured.

Erectile Function measured by International Index of Erectile Function (IIEF-5). The International Index of Erectile Function-5 (IIEF-5) is an five-item Index developed to diagnose the presence and severity of erectile dysfunction (ED). The five items are based on ability to identify the presence or absence of ED and on adherence to the National Institute of Health's definition of ED. These items focus on erectile function and intercourse satisfaction. The items are rated on a scale from 1-5 (e.g., 1=Very low to 5=Very high; 1=Almost never/never to 5=Almost always/always; 1=Extremely difficult to 5=Not difficult). The IIEF-5 score is the sum of questions 1 to 5 (Scores range from 5-25). ED was classified into five severity levels, ranging from none (22-25) through severe (5-7).

The International prostate symptom score (IPSS) questionnaire has seven questions, which are used to evaluate storage and voiding symptoms. The patient is given ﬁve options for the ﬁrst seven questions and each option indicates severity of that symptom. The total score ranges from 0 to 35 and Lower Urinary Tract Symptoms (LUTS) are classiﬁed as mild to severe depending on the total score. Patients having a total score ≤7 are classiﬁed as having mild symptoms, scores from 8 to 19 are classiﬁed as moderate symptoms, and symptom scores ≥20 are classiﬁed as severe symptoms.

PSA response will be measured as the change of serum PSA in ng/mL between preoperative / screening examination and at follow-up 6 weeks after surgery

B.Braun Surgical SA

Aesculap AG

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer.

Laparoscopic myomectomy with unidirectional barbed suture

Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.

Traditional suture material

Jamie Kroft, MD, FRCSC

Grace Y Liu, MD, FRCSC

The objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical outcomes. Specifically, the investigators will investigate the effect of barbed suture on operative time, blood loss, adverse post-operative events and hospital stay.

Although the laparoscopic myomectomy has benefits over the abdominal approach, such as less blood loss, less hemoglobin drop post-operatively, decreased post-operative pain and fewer overall complications, it is a difficult procedure, which often requires greater operative time to perform. In the current climate of attempting to reduce health care expenditures, even though the minimally invasive approach offers the advantage of reduced hospital stay, a deterrent for hospital administration and surgeons may be the increased operative time it may require. Barbed suture is a relatively new material available in gynecologic surgery. Barbs are cut into the suture with the barbs facing in a direction opposite that of the needle. The barbs allow for anchoring of the suture in tissues, which prevents migration and allows suturing without knot tying. This study will be a single-centre non-blinded randomized controlled trial comparing laparoscopic myomectomy with barbed suture versus traditional suture material.

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial

We will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.

We will subtract the amount of irrigation fluid used from the total amount of fluid suctioned during the procedure to arrive at an estimated blood loss in millilitres. We will also measure the patient's hemoglobin at the routine pre-operative visit and then on the morning of the first post-operative day to determine the difference in hemoglobin. The amount of intravenous fluids administered to the patients intra- and post-operatively will be documented in order to account for any changes in hemoglobin that are spurious due to fluid administration.

All adverse events that occur until 6 weeks post-operatively will be documented including injury to the bladder, bowel, ureter or blood vessel, infection/abscess, fever, blood transfusion, readmission to hospital, re-operation, and venous thromboembolism.

We will document the length of hospital stay post-operatively in days.

Telephone interviews will be conducted at 2 and 5 years post-operatively to determine pregnancy rates, live birth rates and adverse pregnancy outcomes of participants.

Sunnybrook Health Sciences Centre

Symptoms and General Pathology

Infertility

Tissue Adhesions

Cicatrix

Fibrosis

Neoplasms, Connective Tissue

Connective Tissue Diseases

Laparoscopic surgery utilizing V-Loc suture

V-Loc suture will be utilized in the repair of the uterus following removal of fibroid tumors. a second look laparoscopy will be done on all subjects to evaluate scar tissue formation.

surgery utilizing V-Loc suture

Charles E Miller, MD

Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the myomectomy, adhesions will be assessed using a modified AFS scoring technique. All investigators will provide usual and customary care to research subjects during the first look laparoscopy. This includes the use of all standard practice anti-adhesive agents and heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and reevaluated via modified American Fertility Society scoring techniques. An independent reviewer will also score adhesions utilize a video recording made from the second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks post -op and assessed for complications. It is the expectation that patients will show no greater post-operative adhesion formation and a \<1% complication rate. Time and ease of suturing will also be evaluated. It is expected that the V-Loc suturing technique will show significantly reduced suturing time, be easier to use, and will be associated with minimal adhesions.

This is a post-market, controlled, single-center study to evaluate V-Loc suture. 10 subjects will be included in this study. Premenopausal women ages 18-42 will undergo a laparoscopic myomectomy. Adhesion scoring will be done prior to the myomectomy using a modified American Fertility Society scoring technique. V-loc 180 suture will be utilized in all patients for closure of all uterine defects. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and evaluated via modified American Fertility Society scoring techniques.

An independent reviewer will also score adhesions utilizing video recordings made from the second look laparoscopic surgery , using the same scoring techniques employed by the PI..

Patients will undergo routine preoperative blood tests in accordance with the Primary Investigators' usual standard of practice. All patients who meet the inclusion criteria will be considered. Patients will be consented prior to entry into the operating room. Surgical time will be measured from start of procedure, start of myomectomy, and start and finish time of each individual uterine closure. All investigators will provide usual and customary care to research subjects during the first look laparoscopy. This includes the use of all standard practice anti-adhesive agents and heparinized irrigation fluids

. Physicians will be surveyed on ease of use and any problems that occur with V-Loc suture.

All patients will be treated with post-operative antibiotics per the Primary Investigator's usual standard of care. Patients will be contacted both one and 4 weeks post surgery and evaluated for complications using a phone survey for pain and bowel functioning. The patient will also have a standard post operative exam with the physician 4-6 weeks post-operatively. A second look laparoscopy will be performed 6-12 weeks following the initial myomectomy. Adhesions will be evaluated using a modified American Fertility Society evaluation tool. Any adhesions seen at the time of SLL will be treated using the physician's preferred method of adhesiolysis. A recording will be obtained of the second look laparoscopy and will be reviewed and scored by an independent reviewer as to the level of adhesions seen .

a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.

A Case Study to Evaluate Adhesion Risk in Fertility Patients' Post Laparoscopic Myomectomy Utilizing Vloc Suture.

The primary objective of this study is to evaluate post operative adhesion formation after using V-Loc™ 180 during laparoscopic myomectomy.

The time required to close the incision as well as the ease of use to the surgeon will be measured .

Medtronic - MITG

The Advanced Gynecologic Surgery Institute

President

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Hemorrhage

Endometriosis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Prolapse

Unconsciousness

Uterine Prolapse

Uterine Neoplasms

Uterine Hemorrhage

Endometrial Neoplasms

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Diseases

Pathological Conditions, Anatomical

Fallopian Tube Diseases

Pelvic Organ Prolapse

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Closure of the Vaginal Cuff after Total Hysterectomy

Petra Baumann

Amadeus Hornemann, Prof. Dr.

Lourdes Hinojosa Sánchez, Dra.

Arantxa Monteils Llabenia, Dra.

Núria Grané Garcia, Dra

Carmen Bergos Sorolla, Dra.

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.

Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).

Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours

Documented complications include Vaginal cuff infection, Vaginal cuff dehiscence (Defined as a visually confirmed partial or complete opening of the vaginal stump with or without visceral organ herniation), Vaginal cuff granulation formation, Pelvic Abscess Formation, Hematoma, Vaginal spotting (defined as bloody vaginal discharge that did not require extraordinary procedures or medication and disappeared spontaneously. (Days of postoperative bleeding, Number of pads / tampons used), Vaginal bleeding (Defined as postoperative vaginal stump bleeding that required additional stump suture to stop bleeding. (Days of postoperative bleeding, number of pads / tampons used), Urinary tract infection, Bladder injury, Ureter injury, Bowel obstruction, Ileus, Cystitis and Pelvic Adhesions.

Documented device deficiencies include Suture rupture, Knots in the thread, Connection between needle and thread not intact and Disconnection of the anchor from the thread

The patient's self assessment of her satisfaction with the surgery. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "low" and "100" at the opposite end representing "high". The value is measured in \[mm\] with a ruler and documented in whole numbers.

The Female Sexual Function Index (FSFI) is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function as well as the primary components of sexual function in women, including sexual desire, arousal, orgasm, pain, and satisfaction. The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. (0 points in some cases for items that are not applicable). To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal and lubrication; 0.4 for orgasm, satisfaction and pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score. The domain scores range from 1.2 - 6, the overall score ranges from 7.2 - 36.

From the first cut to the end of the surgery

Calculation using the length of hospitalization (days until discharge), suturing time, suture costs and needed transfusions)

calculated by subtracting the surgery date from the date of discharge

The patient's self assessment of her abdominal pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in \[mm\] with a ruler and documented in whole numbers

The patient's self assessment of her pelvic pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in \[mm\] with a ruler and documented in whole numbers

The patient's self assessment of her lumbar pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in \[mm\] with a ruler and documented in whole numbers

The patient's self assessment of her general health status. Health status is based on assessment of the patient to the question, "Would you say your health in general is...:" The options are excellent / very good / good / fair / poor

Dyspareunia is defined by genital pain that can be experienced before, during, or after intercourse. The patient answers with yes or no.

Assessment of the handling of the unidirectional barbed suture (SYMMCORA®) intra-operatively including eleven different dimensions (pliability, Pass-through, traumaticity, anchoring capacity, safety of closure, locking system size, locking system deployment, locking system unbarbed area, locking system safety of closure, atraumaticity, wound closure approximation) and an overall impression with 5 evaluations levels (excellent, very good, good, satisfied, poor).

Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture regarding degree of difficulties and the ease of handling. (Likert Scale: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).

Assessment of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc®) regarding smoothness, suppleness, traumaticity of the thread, the handling, the opening of the package and the overall opinion (Likert Scale: worse, equal, better).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery	NCT05872334	Colon Cancer Rectal Cancer Colon Adenocarc... Rectal Adenocar...	Monofix	18 Years - 80 Years	Samsung Medical Center
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy	NCT06055946	Prostate Cancer	robotic assiste...	18 Years -	Aesculap AG
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy	NCT01347385	Fibroids	Laparoscopic my... Traditional sut...	-	Sunnybrook Health Sciences Centre
a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.	NCT01971060	Uterine Fibroid... Infertility	surgery utilizi...	18 Years - 42 Years	The Advanced Gynecologic Surgery Institute
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy	NCT01347385	Fibroids	Laparoscopic my... Traditional sut...	-	Sunnybrook Health Sciences Centre
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy	NCT06055946	Prostate Cancer	robotic assiste...	18 Years -	Aesculap AG
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy	NCT06024109	Abnormal Uterin... Endometriosis Uterine Prolaps... Uterine Cancer Ovarian Cancer Fallopian Tube ... Cervical Cancer Endometrial Can...	Closure of the ...	18 Years -	Aesculap AG

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