Gynecologic CancersBI-SURENCT07313839
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
A study testing Double-Layer Vaginal Vault Closure with Self-Locking Suture and Double-Layer Vaginal Vault Closure with Polyglactin 910 in people with Gynecologic Cancers and Vaginal Cuff Dehiscence, run by Azienda Ospedaliero-Universitaria di Parma at 5 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers, Vaginal Cuff Dehiscence, Postoperative Complications
- What is being tested?
- Double-Layer Vaginal Vault Closure with Self-Locking Suture and Double-Layer Vaginal Vault Closure with Polyglactin 910
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 5 sitesItaly
- Study dates
- 7 Oct 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
- Age ≥ 18 years
- Ability to provide written informed consent
Who cannot join
- Laparotomic or vaginal hysterectomy
- Contraindication to laparoscopic vaginal vault closure
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Not yet recruiting
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Bologna
De Iaco, pierandrea.deiaco@unibo.it
- Recruiting
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
Cuneo
Puppo, puppoand@hotmail.com
- Not yet recruiting
Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Milan
Bogani, bogani.giorgio@gmail.com
- Recruiting
Department of Medicine and Surgery, University Hospital of Parma
Parma, Italy, 43125
Capozzi, 0521704819, vcapozzi@ao.pr.it
- Not yet recruiting
Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Udine
Vizzielli, giuseppevizzielli@yahoo.it
About this study
Official title: Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Double-Layer Vaginal Vault Closure with Self-Locking Suture, Double-Layer Vaginal Vault Closure with Polyglactin 910
- Keywords
- Laparoscopic hysterectomy, Vaginal vault closure, Colporrhaphy, Self-locking suture, Barbed suture, Polyglactin 910, Gynecologic oncology, Postoperative complications, Randomized controlled trial
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-Layer Vaginal Vault Closure with Self-Locking SutureProcedure or surgery
Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.
Double-Layer Vaginal Vault Closure with Polyglactin 910Procedure or surgery
Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Self-Locking Suture Group | Experimental | 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. Receives: Procedure: Double-Layer Vaginal Vault Closure with Self-Locking Suture |
| Traditional Suture Group | Active comparator | 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. Receives: Procedure: Double-Layer Vaginal Vault Closure with Polyglactin 910 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal cuff dehiscence rate
Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy.
Measured: 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.
Measured: Within 3 months after surgery
Postoperative bleeding rate
Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment.
Measured: Within 3 months after surgery
Secondary outcomes (2)
Postoperative pain intensity
Postoperative pain assessed using the Visual Analogue Scale (VAS).
Measured: 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.
Measured: Within 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start7 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, pragmatic, randomized controlled trial with a parallel assignment design. Eligible patients will be randomized in a 1:1 ratio to receive either double-layer self-locking sutures or double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure following hysterectomy for gynecologic malignancy. The study is triple-blinded, with participants, outcome assessors, and statisticians masked to treatment allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Andrea Capozzi, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313839
- Sponsor's protocol ID
- 415/2024/DISP/AOUPR
- Acronym
- BI-SURE
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07313839
- Acronym / sponsor ID
- BI-SURE / 415/2024/DISP/AOUPR
- Keywords
- Laparoscopic hysterectomy, Vaginal vault closure, Colporrhaphy, Self-locking suture, Barbed suture, Polyglactin 910, Gynecologic oncology, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter, pragmatic, randomized controlled trial with a parallel assignment design. Eligible patients will be randomized in a 1:1 ratio to receive either double-layer self-locking sutures or double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure following hysterectomy for gynecologic malignancy. The study is triple-blinded, with participants, outcome assessors, and statisticians masked to treatment allocation.
| Arm | Type | Receives |
|---|---|---|
| Self-Locking Suture Group | Experimental | Procedure: Double-Layer Vaginal Vault Closure with Self-Locking SutureParticipants 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. |
| Traditional Suture Group | Active comparator | Procedure: Double-Layer Vaginal Vault Closure with Polyglactin 910Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
- Age ≥ 18 years
- Ability to provide written informed consent
Key exclusion criteria (2 listed)
- Laparotomic or vaginal hysterectomy
- Contraindication to laparoscopic vaginal vault closure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-Layer Vaginal Vault Closure with Self-Locking SutureLaparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy. | Procedure or surgery | Self-Locking Suture Group |
| Double-Layer Vaginal Vault Closure with Polyglactin 910Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy. | Procedure or surgery | Traditional Suture Group |
Primary outcome
Vaginal cuff dehiscence rate
Time frame: Within 3 months after surgery
Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy.
Vaginal cuff infection rate
Time frame: Within 3 months after surgery
Proportion of participants developing vaginal cuff infection, defined as abnormal vaginal discharge with or without fever, leukocytosis, and/or local tenderness, requiring antibiotic therapy.
Postoperative bleeding rate
Time frame: Within 3 months after surgery
Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment.
2 secondary outcomes
Postoperative pain intensity
Time frame: At 1 month and 3 months after surgery
Early postoperative composite complication rate
Time frame: Within 1 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-Layer Vaginal Vault Closure with Self-Locking Suture and Double-Layer Vaginal Vault Closure with Polyglactin 910 in people with Gynecologic Cancers and Vaginal Cuff Dehiscence, run by Azienda Ospedaliero-Universitaria di Parma at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vito Andrea Capozzi (0521704819, vcapozzi@ao.pr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal cuff dehiscence rate (time frame: Within 3 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.