NCT02453165

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,408 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Surgical Wound Dehiscence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2015-05-25
• Last updated: 2018-03-30

Locations

1 site across 1 country: Italy