Vaginal Cuff ComplicationsBARDNCT05833204
BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy
A study testing Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture and Laparoscopic colporrhaphy with standard 0-caliber absorbable suture in people with Vaginal Cuff Complications, run by Universita di Verona at 1 site in Italy.
Trial summary
Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Cuff Complications
- What is being tested?
- Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture and Laparoscopic colporrhaphy with standard 0-caliber absorbable suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,614 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Dec 2028
- 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 elective total laparoscopic hysterectomy
- Surgery performed for the treatment of benign pathology
- Age > 18 years
- Surgery performed by laparoscopy
- Signature of informed consent
Who cannot join
- Patients undergoing emergent surgery
- Patients candidates for hysterectomy for oncological indication
- Patients who underwent previous radiation therapy
- Patients allergic to the suture material used in the study
- Patients unable to express adequate informed consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125
About this study
Official title: Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications.
Among other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators.
Therefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.
- Conditions
- Vaginal Cuff Complications
- Being tested
- Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture, Laparoscopic colporrhaphy with standard 0-caliber absorbable suture
- Keywords
- Laparoscopy, Hysterectomy, Vaginal cuff closure, Barbed sutures, Vaginal cuff complications, Vaginal cuff dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colporrhaphy with 0-caliber barbed absorbable sutureProcedure or surgery
After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)
Laparoscopic colporrhaphy with standard 0-caliber absorbable sutureProcedure or surgery
After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ)
| Study group | Role | What they receive |
|---|---|---|
| Colporrhaphy with barbed absorbable suture | Experimental | The colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic) Receives: Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture |
| Colporrhaphy with standard absorbable suture | Active comparator | The colporrhaphy will be performed using a standard 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ) Receives: Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal cuff dehiscence
Any partial or total separation of the vaginal cuff
Measured: 30 days after surgery
Vaginal cuff dehiscence
Any partial or total separation of the vaginal cuff
Measured: 90 days after surgery
Secondary outcomes (8)
Vaginal cuff complications
Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff
Measured: 30 days after surgery
Vaginal cuff complications
Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff
Measured: 90 days after surgery
Hospital stay
Days of hospitalization from the day of admission to the day of discharge.
Measured: From the date of hospital admission to the date of hospital discharge.
Operative time
Time between first incision and skin closure
Measured: During surgery
Intraoperative blood loss
Total blood aspirate during the surgical procedure
Measured: During surgery
30-day post-surgical morbidity
Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Measured: 30 days after surgery
Quality of life index
The Short Form 12 Health Survey (SF-12) investigates 8 different health aspects. Physical activity, role and physical health, role and emotional state, and mental health are measured by two questions. The SF-12 scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 90 days after surgery
Sexual function
The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function.
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaginal Cuff ComplicationsStudies 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
- Multicenter, parallel arms, open-label, randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Universita di Verona
- Investigators
- Stefano Uccella, MD, PhD, Principal investigator, Universita di VeronaSimone Garzon, MD, Principal investigator, Universita di VeronaPier Carlo Zorzato, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833204
- Sponsor's protocol ID
- BARD
- Acronym
- BARD
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uccella S, Zorzato PC, Kho RM. Incidence and Prevention of Vaginal Cuff Dehiscence after Laparoscopic and Robotic Hysterectomy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2021 Mar;28(3):710-720. doi: 10.1016/j.jmig.2020.12.016. Epub 2021 Jan 5.
PubMed 33348012Uccella S, Malzoni M, Cromi A, Seracchioli R, Ciravolo G, Fanfani F, Shakir F, Gueli Alletti S, Legge F, Berretta R, Corrado G, Casarella L, Donarini P, Zanello M, Perrone E, Gisone B, Vizza E, Scambia G, Ghezzi F. Laparoscopic vs transvaginal cuff closure after total laparoscopic hysterectomy: a randomized trial by the Italian Society of Gynecologic Endoscopy. Am J Obstet Gynecol. 2018 May;218(5):500.e1-500.e13. doi: 10.1016/j.ajog.2018.01.029. Epub 2018 Feb 2.
PubMed 29410107
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05833204
- Acronym / sponsor ID
- BARD / BARD
- Conditions
- Vaginal Cuff Complications
- Keywords
- Laparoscopy, Hysterectomy, Vaginal cuff closure, Barbed sutures, Vaginal cuff complications, Vaginal cuff dehiscence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,614 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Apr 2023 (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.
Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications.
Among other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators.
Therefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, parallel arms, open-label, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Colporrhaphy with barbed absorbable suture | Experimental | Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable sutureThe colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic) |
| Colporrhaphy with standard absorbable suture | Active comparator | Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable sutureThe colporrhaphy will be performed using a standard 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective total laparoscopic hysterectomy
- Surgery performed for the treatment of benign pathology
- Age > 18 years
- Surgery performed by laparoscopy
- Signature of informed consent
Key exclusion criteria (5 listed)
- Patients undergoing emergent surgery
- Patients candidates for hysterectomy for oncological indication
- Patients who underwent previous radiation therapy
- Patients allergic to the suture material used in the study
- Patients unable to express adequate informed consent to participate in the study
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 |
|---|---|---|
| Laparoscopic colporrhaphy with 0-caliber barbed absorbable sutureAfter the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic) | Procedure or surgery | Colporrhaphy with barbed absorbable suture |
| Laparoscopic colporrhaphy with standard 0-caliber absorbable sutureAfter the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ) | Procedure or surgery | Colporrhaphy with standard absorbable suture |
Primary outcome
Vaginal cuff dehiscence
Time frame: 30 days after surgery
Any partial or total separation of the vaginal cuff
Vaginal cuff dehiscence
Time frame: 90 days after surgery
Any partial or total separation of the vaginal cuff
8 secondary outcomes
Vaginal cuff complications
Time frame: 30 days after surgery
Vaginal cuff complications
Time frame: 90 days after surgery
Hospital stay
Time frame: From the date of hospital admission to the date of hospital discharge.
Operative time
Time frame: During surgery
Intraoperative blood loss
Time frame: During surgery
30-day post-surgical morbidity
Time frame: 30 days after surgery
Quality of life index
Time frame: 90 days after surgery
Sexual function
Time frame: 90 days 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 29 Apr 2026.
- Background: PubMed 33348012Uccella S, Zorzato PC, Kho RM. Incidence and Prevention of Vaginal Cuff Dehiscence after Laparoscopic and Robotic Hysterectomy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2021 Mar;28(3):710-720. doi: 10.1016/j.jmig.2020.12.016. Epub 2021 Jan 5.
- Background: PubMed 29410107Uccella S, Malzoni M, Cromi A, Seracchioli R, Ciravolo G, Fanfani F, Shakir F, Gueli Alletti S, Legge F, Berretta R, Corrado G, Casarella L, Donarini P, Zanello M, Perrone E, Gisone B, Vizza E, Scambia G, Ghezzi F. Laparoscopic vs transvaginal cuff closure after total laparoscopic hysterectomy: a randomized trial by the Italian Society of Gynecologic Endoscopy. Am J Obstet Gynecol. 2018 May;218(5):500.e1-500.e13. doi: 10.1016/j.ajog.2018.01.029. Epub 2018 Feb 2.
- Individual participant dataSharing planned: No
Related trials for Vaginal Cuff Complications
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 1/2
Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy
Pain, Postoperative
Recruiting
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Gynecologic Cancers, Vaginal Cuff Dehiscence
Recruiting
Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy
Postoperative Pain
Active, not recruitingPhase 1
Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer
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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.
Stefano Uccella, MD, PhD principal investigator
Universita di Verona
Simone Garzon, MD principal investigator
Universita di Verona
Pier Carlo Zorzato, MD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture and Laparoscopic colporrhaphy with standard 0-caliber absorbable suture in people with Vaginal Cuff Complications, run by Universita di Verona at 1 site 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Stefano Uccella, MD, PhD (0039 045 812 2720, stefano.uccella@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal cuff dehiscence (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833204, which also lists 2 linked publications.
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 29 Apr 2026.