Double-layer vaginal vault closure with self-locking versus traditional sutures after laparoscopic hysterectomy for gynecologic cancer
Official title: Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial
Run by Azienda Ospedaliero-Universitaria di Parma · NCT07313839 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 310 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma Academic / other |
| Locations | 5 sites (Parma, Italy and 4 other locations) |
| Status | Recruiting |
| Started | October 7, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT07313839 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Department of Medicine and Surgery, University Hospital of Parma
Parma, Italy, Italy Recruiting -
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
Cuneo, Italy Recruiting -
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Bologna, Italy Not yet 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.