An interventional study of Double-Layer Vaginal Vault Closure with Self-Locking Suture and Double-Layer Vaginal Vault Closure with Polyglactin 910 in Gynecologic Cancers, Vaginal Cuff Dehiscence and Postoperative Complications, sponsored by Azienda Ospedaliero-Universitaria di Parma. Recruiting at 5 sites in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Azienda Ospedaliero-Universitaria di Parma · Not applicable, Interventional, and Treatment
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.
Laparoscopic and robotic hysterectomy represent standard surgical approaches for the treatment of gynecologic malignancies but are associated with a higher risk of vaginal vault complications compared with open or vaginal surgery. Although uncommon, postoperative complications such as vaginal cuff dehiscence, infection, and bleeding may lead to significant morbidity and require additional medical or surgical interventions.
Vaginal vault closure can be performed using different suturing techniques and materials. Traditional braided sutures, such as Polyglactin 910, are widely used in clinical practice, while self-locking (barbed) sutures have been introduced to facilitate laparoscopic suturing by maintaining tissue approximation without the need for knots. Evidence comparing these sutures is limited, particularly for double-layer closure techniques and in patients treated for gynecologic malignancies.
The BI-SURE trial is a multicenter, pragmatic, randomized controlled trial designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure following hysterectomy for malignant gynecologic disease. Eligible patients will be randomized in a 1:1 ratio. Postoperative outcomes will be assessed up to three months after surgery, including vaginal cuff-related complications and postoperative pain.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 310 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Azienda Ospedaliero-Universitaria di Parma is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Double-Layer Vaginal Vault Closure with Self-Locking Suture
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.
Procedure: Double-Layer Vaginal Vault Closure with Polyglactin 910
Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.
Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.
Vaginal cuff dehiscence rate
Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy.
Time frame: Within 3 months after surgery
Vaginal cuff infection rate
Proportion of participants developing vaginal cuff infection, defined as abnormal vaginal discharge with or without fever, leukocytosis, and/or local tenderness, requiring antibiotic therapy.
Time frame: Within 3 months after surgery
Postoperative bleeding rate
Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment.
Time frame: Within 3 months after surgery
Postoperative pain intensity
Postoperative pain assessed using the Visual Analogue Scale (VAS).
Time frame: At 1 month and 3 months after surgery
Early postoperative composite complication rate
Proportion of participants experiencing vaginal cuff dehiscence, infection, or bleeding before the initiation of adjuvant therapy.
Time frame: Within 1 month after surgery
Plan to share: No — Individual participant data (IPD) will not be shared because the study is conducted within a hospital-based academic setting and no data repository has been designated for public data release. Data will be stored securely at the sponsor institution and will be accessible only to authorized study personnel in compliance with applicable privacy regulations.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero-Universitaria di Parma