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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Endometriosis; Ovarian Cancer; Fallopian Tube Cancer; Endometrial Cancer; Uterine Prolapse; Uterine Cancer; Abnormal Uterine Bleeding
• Intervention / Treatment: Device: Closure of the Vaginal Cuff after Total Hysterectomy

• Study Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: Petra Baumann; Phone Number: 1646 +49746195; Email: petra.baumann@aesculap.de

Study Locations

• Germany
  • Hessen
    • Frankfurt/Main, Hessen, Germany, 60594
      • Recruiting
      • Klinikum Sachsenhausen der DGD
      • Contact: Amadeus Hornemann, Prof. Dr.
      • Principal Investigator: Amadeus Hornemann, Prof. Dr.
• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Not yet recruiting
      • Hospital Sant Joan de Déu de Manresa
      • Sub-Investigator: Arantxa Monteils Llabenia, Dra.
      • Contact: Lourdes Hinojosa Sánchez, Dra.
      • Principal Investigator: Lourdes Hinojosa Sánchez, Dra.
      • Sub-Investigator: Núria Grané Garcia, Dra
      • Sub-Investigator: Carmen Bergos Sorolla, Dra.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female patients undergoing an elective, laparoscopic total hysterectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SYMMCORA®; 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).	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).; Other Names: Suturing
V-Loc®; 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).	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).; Other Names: Suturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
Overall operation time	From the first cut to the end of the surgery	intraoperatively
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)
Length of postoperative hospital stay	calculated by subtracting the surgery date from the date of discharge	at discharge (approximately 10 days after surgery)
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
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
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
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
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)
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
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
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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Amadeus Hornemann, Prof. Dr., Klinikum Sachsenhausen der DGD

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopy; Hysterectomy; Minimal Invasive; Barbed Suture
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Adnexal Diseases; Hemorrhage; Pathological Conditions, Anatomical; Fallopian Tube Diseases; Pelvic Organ Prolapse; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis; Fallopian Tube Neoplasms; Prolapse; Endometrial Neoplasms; Uterine Neoplasms; Uterine Hemorrhage; Uterine Prolapse
• Other Study ID Numbers: AAG-O-H-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No