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Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure

NCT02453165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1408

Last updated 2018-03-30

No results posted yet for this study

Summary

Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.

The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.

Conditions

  • Surgical Wound Dehiscence

Interventions

PROCEDURE

TRANSVAGINAL SUTURE

The closure of the vaginal cuff will be performed transvaginally using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with vaginal valves and needleholders

PROCEDURE

LAPAROSCOPIC SUTURE

The closure of the vaginal cuff will be performed laparoscopically using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with laparoscopic needleholders

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Stefano Uccella, MD, PhD · Università degli Studi dell'Insubria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453165 on ClinicalTrials.gov