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

Aesculap

Status: Enrolling

Conditions: Endometrial Cancer; Uterine Prolapse; Uterine Cancer; Endometriosis; Fallopian Tube Cancer; Ovarian Cancer; Abnormal Uterine Bleeding; Cervical Cancer

Treatments: Device: Closure of the Vaginal Cuff after Total Hysterectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT06024109

AAG-O-H-2001

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

SYMMCORA®

Description:

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).

Treatment:

Device: Closure of the Vaginal Cuff after Total Hysterectomy

V-Loc®

Description:

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).

Treatment:

Device: Closure of the Vaginal Cuff after Total Hysterectomy