Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
- Conditions
- Uterine ProlapseUterine CancerCervical CancerAbnormal Uterine BleedingEndometriosisOvarian CancerEndometrial CancerFallopian Tube Cancer
- Interventions
- Device: Closure of the Vaginal Cuff after Total Hysterectomy
- Registration Number
- NCT06024109
- Lead Sponsor
- Aesculap AG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 132
- Females undergoing an elective, laparoscopic total hysterectomy
- Age ≥ 18 years
- Written informed consent
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SYMMCORA® Closure of the Vaginal Cuff after Total Hysterectomy 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). V-Loc® Closure of the Vaginal Cuff after Total Hysterectomy 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).
- Primary Outcome Measures
Name Time Method Suturing time to close the vaginal cuff intraoperatively 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).
- Secondary Outcome Measures
Name Time Method Number of patients with complications over the study period at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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.
Number of patients with early complications at discharge (up to 10 days after surgery) Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours
Number of patients with device deficiencies over the study period intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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
Progress of Patient's pelvic pain (VAS 0-100) compared to baseline preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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
Progress of Patient's lumbar pain (VAS 0-100) compared to baseline preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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
Patient assessment of postoperative Dyspareunia at both follow-up visits (6-8 weeks postoperatively and 6 months postoperatively) 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 barbed suture (SYMMCORA®) compared to conventional suture intraoperatively 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).
Overall operation time intraoperatively From the first cut to the end of the surgery
Progress of General Health Status compared to baseline preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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
Cost of treatment at discharge (approximately 10 days after surgery) Calculation using the length of hospitalization (days until discharge), suturing time, suture costs and needed transfusions)
Patient satisfaction (VAS 0-100) over time at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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.
Length of postoperative hospital stay at discharge (approximately 10 days after surgery) calculated by subtracting the surgery date from the date of discharge
Assessment of the handling of the barbed suture (SYMMCORA®) intraoperatively 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 barbed suture (V-Loc) intraoperatively 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).
Progress of Female Sexual Function Index (FSFI) compared to baseline Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively 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.
Progress of Patient's abdominal pain (VAS 0-100) compared to baseline preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively 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
Trial Locations
- Locations (2)
Klinikum Sachsenhausen der DGD
🇩🇪Frankfurt/Main, Hessen, Germany
Hospital Sant Joan de Déu de Manresa
🇪🇸Manresa, Barcelona, Spain