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

Ovarian Cancer Clinical Trial

— BARHYSTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024109
• Other study ID #: AAG-O-H-2001
• Status: Recruiting
• Start date: March 19, 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: Petra Baumann
• Phone: +49746195
• Email: petra.baumann[@]aesculap.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females undergoing an elective, laparoscopic total hysterectomy

• Age = 18 years

• Written informed consent

Exclusion Criteria:

• Emergency surgery

• Open surgery

• Patients undergone immunosuppressive drug treatment within the prior 6 months

• Patients with hypersensitivity or allergy to the suture material.

• Participation in another clinical study

• Non-compliance of patient

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Endometriosis
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Prolapse
• Uterine Cancer
• Uterine Hemorrhage
• Uterine Neoplasms
• Uterine Prolapse

Intervention

Device:
• Closure of the Vaginal Cuff after Total Hysterectomy
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).

Locations

Country	Name	City	State
Germany	Klinikum Sachsenhausen der DGD	Frankfurt/Main	Hessen
Spain	Hospital Sant Joan de Déu de Manresa	Manresa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suturing time to close the vaginal cuff	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).	intraoperatively
Secondary	Number of patients with early complications	Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours	at discharge (up to 10 days after surgery)
Secondary	Number of patients with complications over the study period	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.	at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Number of patients with device deficiencies over the study period	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	intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Patient satisfaction (VAS 0-100) over time	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.	at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Progress of Female Sexual Function Index (FSFI) compared to baseline	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.	Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively
Secondary	Overall operation time	From the first cut to the end of the surgery	intraoperatively
Secondary	Cost of treatment	Calculation using the length of hospitalization (days until discharge), suturing time, suture costs and needed transfusions)	at discharge (approximately 10 days after surgery)
Secondary	Length of postoperative hospital stay	calculated by subtracting the surgery date from the date of discharge	at discharge (approximately 10 days after surgery)
Secondary	Progress of Patient's abdominal pain (VAS 0-100) compared to baseline	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	preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Progress of Patient's pelvic pain (VAS 0-100) compared to baseline	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	preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Progress of Patient's lumbar pain (VAS 0-100) compared to baseline	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	preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Progress of General Health Status compared to baseline	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	preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
Secondary	Patient assessment of postoperative Dyspareunia	Dyspareunia is defined by genital pain that can be experienced before, during, or after intercourse. The patient answers with yes or no.	at both follow-up visits (6-8 weeks postoperatively and 6 months postoperatively)
Secondary	Assessment of the handling of the barbed suture (SYMMCORA®)	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).	intraoperatively
Secondary	Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture	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).	intraoperatively
Secondary	Assessment of the handling of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc)	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).	intraoperatively