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OpenTrials
Completed

NCT Number: NCT02453165

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

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.

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Key information

Conditions

Surgical Wound Dehiscence Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

About this study

A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy.

The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault.

The investigators will also compare the two modalities in terms of:

  • duration of the vaginal closure
  • risk of bleeding from the vaginal cuff
  • risk of post-operative pelvic infection
  • risk of re-operation
  • dyspareunia
  • total vaginal length
  • vaginal cuff prolapse.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy

Exclusion criteria

  • Patients with gynecological malignancy (uterine and/or adnexal)

Treatment and study plan

TRANSVAGINAL SUTURE

Procedure

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

LAPAROSCOPIC SUTURE

Procedure

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

Primary outcomes

  1. VAGINAL DEHISCENCE

    Time frame: 3 months postoperatively

    Vaginal dehiscence defined as any partial or complete separation of the vaginal vault, sutured at the end of a total laparoscopic hysterectomy.

    This complication is diagnosed clinically, during a gynecologic visit. Every dehiscence (whether partial or total) will be considered as an outcome event and we will measure the presence/absence of dehiscence as a percentage of the total procedures.

Secondary outcomes

  1. VAGINAL CUFF COMPLICATIONS

    Time frame: 3 months postoperatively

    • Vaginal bleeding
    • Need for Vaginal re-suture
    • Vaginal vault prolapse
    • Dyspareunia
    • Post-operative pelvic infection

  2. operative time

    Time frame: During Operation

    Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 25, 2015
Registry last updated
Mar 30, 2018

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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