Clinical trial NCT06024109: Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abnormal Uterine Bleeding
Endometriosis
Uterine Prolapse
Uterine Cancer
Ovarian Cancer
Fallopian Tube Cancer
Cervical Cancer
Endometrial Cancer
Keywords: Barbed Suture
Hysterectomy
Laparoscopy
Minimal Invasive
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-09-06
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients undergoing an elective, laparoscopic total hysterectomy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Suturing time to close the vaginal cuff
timeFrame: intraoperatively
Secondary outcomes:
measure: Number of patients with early complications
timeFrame: at discharge (up to 10 days after surgery)
measure: Number of patients with complications over the study period
timeFrame: at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Number of patients with device deficiencies over the study period
timeFrame: intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Patient satisfaction (VAS 0-100) over time
timeFrame: at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Progress of Female Sexual Function Index (FSFI) compared to baseline
timeFrame: Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively
measure: Overall operation time
timeFrame: intraoperatively
measure: Cost of treatment
timeFrame: at discharge (approximately 10 days after surgery)
measure: Length of postoperative hospital stay
timeFrame: at discharge (approximately 10 days after surgery)
measure: Progress of Patient's abdominal pain (VAS 0-100) compared to baseline
timeFrame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Progress of Patient's pelvic pain (VAS 0-100) compared to baseline
timeFrame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Progress of Patient's lumbar pain (VAS 0-100) compared to baseline
timeFrame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Progress of General Health Status compared to baseline
timeFrame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
measure: Patient assessment of postoperative Dyspareunia
timeFrame: at both follow-up visits (6-8 weeks postoperatively and 6 months postoperatively)
measure: Assessment of the handling of the barbed suture (SYMMCORA®)
timeFrame: intraoperatively
measure: Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture
timeFrame: intraoperatively
measure: Assessment of the handling of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc)
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Klinikum Sachsenhausen der DGD
state: Hessen
city: Manresa
country: Spain
facility: Hospital Sant Joan de Déu de Manresa
state: Barcelona
Study officials:
affiliation: Klinikum Sachsenhausen der DGD
name: Amadeus Hornemann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: