Double-layer vaginal vault closure with self-locking versus traditional sutures after laparoscopic hysterectomy for gynecologic cancer
Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial
This trial tests whether double-layer self-locking (barbed) sutures reduce vaginal cuff complications compared with traditional Polyglactin 910 sutures in adults having laparoscopic or robotic hysterectomy for gynecologic cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma Academic / other |
| Locations | 5 sites (Parma, Italy and 4 other locations) |
| Trial ID | NCT07313839 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized controlled trial comparing double-layer self-locking (barbed) sutures to double-layer Polyglactin 910 sutures for laparoscopic or robot-assisted vaginal vault closure after hysterectomy for malignant gynecologic disease. Eligible patients are randomized 1:1 at participating Italian centers and undergo the assigned closure technique as part of their planned minimally invasive surgery. Outcomes including vaginal cuff dehiscence, infection, bleeding, and postoperative pain are recorded for up to three months after surgery. The trial is pragmatic in design and focuses on the effectiveness and safety of the two suture approaches specifically in the oncologic setting.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing laparoscopic or robot-assisted hysterectomy for gynecologic malignancy who can provide written informed consent are the intended participants.
Not a fit: Patients undergoing open (laparotomic) or vaginal hysterectomy or those with contraindications to laparoscopic vaginal vault closure are unlikely to be eligible or to benefit from the comparison.
Why it matters
Potential benefit: If successful, this approach could reduce vaginal cuff complications, postoperative pain, and the need for additional procedures after minimally invasive hysterectomy.
How similar studies have performed: Previous small trials and observational studies, largely in benign hysterectomy, suggest barbed sutures can shorten suturing time with similar short-term complication rates, but robust randomized evidence for double-layer closure in cancer surgery is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease * Age ≥ 18 years * Ability to provide written informed consent Exclusion Criteria: * Laparotomic or vaginal hysterectomy * Contraindication to laparoscopic vaginal vault closure
Where this trial is running
Parma, Italy and 4 other locations
- Department of Medicine and Surgery, University Hospital of Parma — Parma, Italy, Italy (Recruiting)
- Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy. — Bologna, Italy (Not_yet_recruiting)
- Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy. — Cuneo, Italy (Recruiting)
- Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy. — Milan, Italy (Not_yet_recruiting)
- Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy. — Udine, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Vito Andrea Capozzi
- Email: vcapozzi@ao.pr.it
- Phone: 0521704819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.