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

Sponsor

Università degli Studi dell'Insubria (Other)

Overall Status

Completed

CT.gov ID

NCT02453165

Collaborator

(none)

1,408

Enrollment

Location

Arms

27.9

Actual Duration (Months)

50.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Dehiscence	Procedure: TRANSVAGINAL SUTURE Procedure: LAPAROSCOPIC SUTURE	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1408 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

May 31, 2017

Actual Study Completion Date :

May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRANSVAGINAL SUTURE INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders.	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
Active Comparator: LAPAROSCOPIC SUTURE INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic 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

Arm

Intervention/Treatment

Experimental: TRANSVAGINAL SUTURE

INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders.

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

Active Comparator: LAPAROSCOPIC SUTURE

INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic 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

Outcome Measures

Primary Outcome Measures

VAGINAL DEHISCENCE [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 Outcome Measures

VAGINAL CUFF COMPLICATIONS [3 months postoperatively]
Vaginal bleeding Need for Vaginal re-suture Vaginal vault prolapse Dyspareunia Post-operative pelvic infection
operative time [During Operation]
Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy

Exclusion Criteria:

Patients with gynecological malignancy (uterine and/or adnexal)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology Universita' Dell'Insubria	Varese		Italy	21100

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

Principal Investigator: Stefano Uccella, MD, PhD, Università degli Studi dell'Insubria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefano Uccella, Medical Doctor, Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT02453165

Other Study ID Numbers:

First Posted:

May 25, 2015

Last Update Posted:

Mar 30, 2018

Last Verified:

Mar 1, 2018

Keywords provided by Stefano Uccella, Medical Doctor, Università degli Studi dell'Insubria

vaginal dehiscence

Additional relevant MeSH terms:

Surgical Wound Dehiscence

Surgical Wound

Study Results

No Results Posted as of Mar 30, 2018