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

Università degli Studi dell'Insubria

Status: Completed

Conditions: Surgical Wound Dehiscence

Treatments: Procedure: TRANSVAGINAL SUTURE; Procedure: LAPAROSCOPIC SUTURE

Study type: Interventional

Funder types: Other

Identifiers

NCT02453165

440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,408 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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1,408 participants in 2 patient groups

TRANSVAGINAL SUTURE

Experimental group

Description:

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

Treatment:

Procedure: TRANSVAGINAL SUTURE

LAPAROSCOPIC SUTURE

Active Comparator group

Description:

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

Treatment:

Procedure: LAPAROSCOPIC SUTURE