Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03038945

Enrollment

150

Registered

2017-02-01

Start date

2016-10-31

Completion date

2016-11-30

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Surgical Procedures

Keywords

Laparoscopy, Hysterectomy, Suture Techniques

Brief summary

Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.

Interventions

OTHER2/0 barbed suture

Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology

OTHER0/0 Vicryl suture

Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* All patients scheduled for total laparoscopic hysterectomy without other simultaneous procedures , for benign causes , who were agree to participate in the trial and give their written consent. * Patients ASA (American Society of Anesthesiologists) 1 and 2 * Patients who are able to communicate by telephone and answer questions

Exclusion criteria

* Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic obstructive pulmonary disease), collagen diseases, diabetes. * Endometriosis III / IV * Patients who can not be reached by phone

Design outcomes

Primary

Measure	Time frame	Description
Cuff closure time	20 minutes	time spend for vaginal Cuff closure (in minutes)

Secondary

Measure	Time frame	Description
Intra or postoperative complications	10 days	Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam.
Dyspareunia	12 weeks	the visual scale was used to analyze the dyspareunia

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026