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NCT Number: NCT05833204

BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, 37125, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture

Procedure

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 suture

Procedure

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)

Primary outcomes

  1. Vaginal cuff dehiscence

    Time frame: 30 days after surgery

    Any partial or total separation of the vaginal cuff

  2. Vaginal cuff dehiscence

    Time frame: 90 days after surgery

    Any partial or total separation of the vaginal cuff

Secondary outcomes

  1. Vaginal cuff complications

    Time frame: 30 days after surgery

    Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff

  2. Vaginal cuff complications

    Time frame: 90 days after surgery

    Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff

  3. Hospital stay

    Time frame: From the date of hospital admission to the date of hospital discharge.

    Days of hospitalization from the day of admission to the day of discharge.

  4. Operative time

    Time frame: During surgery

    Time between first incision and skin closure

  5. Intraoperative blood loss

    Time frame: During surgery

    Total blood aspirate during the surgical procedure

  6. 30-day post-surgical morbidity

    Time frame: 30 days after surgery

    Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification

  7. Quality of life index

    Time frame: 90 days after surgery

    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.

  8. Sexual function

    Time frame: 90 days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simone Garzon, MD

CONTACT

[email protected]

0039 045 812 2720

Stefano Uccella, MD, PhD

CONTACT

[email protected]

0039 045 812 2720

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial

Acronym: BARD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 27, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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