Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Vaginal vault closure after laparoscopic or robotic hysterectomy may be associated with postoperative complications such as vaginal cuff dehiscence, infection, and bleeding. The optimal suture material and technique for laparoscopic colporrhaphy, particularly in patients undergoing surgery for gynecologic malignancies, remain controversial. The BI-SURE trial is a multicenter, randomized controlled study designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure after hysterectomy. The study aims to evaluate postoperative effectiveness and safety within three months after surgery.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease

• Age ≥ 18 years

• Ability to provide written informed consent

Locations
Other Locations
Italy
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
NOT_YET_RECRUITING
Bologna
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
RECRUITING
Cuneo
Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
NOT_YET_RECRUITING
Milan
Department of Medicine and Surgery, University Hospital of Parma
RECRUITING
Parma
Clinic of Obstetrics and Gynecology, Santa Maria della Misericordia University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
NOT_YET_RECRUITING
Udine
Contact Information
Primary
Vito Andrea Capozzi
vcapozzi@ao.pr.it
0521704819
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2027-01
Participants
Target number of participants: 310
Treatments
Experimental: Self-Locking Suture Group
Participants randomized to this arm will undergo laparoscopic vaginal vault closure after hysterectomy using a double-layer continuous suturing technique performed with a self-locking (barbed) suture, according to current clinical practice.
Active_comparator: Traditional Suture Group
Participants randomized to this arm will undergo laparoscopic vaginal vault closure after hysterectomy using a double-layer continuous suturing technique performed with traditional braided Polyglactin 910 suture, according to current clinical practice.
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliero-Universitaria di Parma

This content was sourced from clinicaltrials.gov