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

Surgical Wound Dehiscence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453165
• Other study ID #: 440
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: March 28, 2018
• Start date: February 1, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: March 2018
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1408
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Dehiscence

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Department of Obstetrics and Gynecology Universita' Dell'Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Ceccaroni M, Berretta R, Malzoni M, Scioscia M, Roviglione G, Spagnolo E, Rolla M, Farina A, Malzoni C, De Iaco P, Minelli L, Bovicelli L. Vaginal cuff dehiscence after hysterectomy: a multicenter retrospective study. Eur J Obstet Gynecol Reprod Biol. 201 — View Citation

Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T. Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011 Oct;118(4):794-801. doi: 10.1097/AOG.0b013e31822f1c92. — View Citation

Kim MJ, Kim S, Bae HS, Lee JK, Lee NW, Song JY. Evaluation of risk factors of vaginal cuff dehiscence after hysterectomy. Obstet Gynecol Sci. 2014 Mar;57(2):136-43. doi: 10.5468/ogs.2014.57.2.136. Epub 2014 Mar 15. — View Citation

Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4 — View Citation

Uccella S, Ceccaroni M, Cromi A, Malzoni M, Berretta R, De Iaco P, Roviglione G, Bogani G, Minelli L, Ghezzi F. Vaginal cuff dehiscence in a series of 12,398 hysterectomies: effect of different types of colpotomy and vaginal closure. Obstet Gynecol. 2012 — View Citation

Uccella S, Ghezzi F, Mariani A, Cromi A, Bogani G, Serati M, Bolis P. Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature. Am J Obstet Gynecol. 2011 Aug;205(2):119.e1-12. doi: 10.1016/j.ajog.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAGINAL DEHISCENCE	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.	3 months postoperatively
Secondary	VAGINAL CUFF COMPLICATIONS	Vaginal bleeding; Need for Vaginal re-suture; Vaginal vault prolapse; Dyspareunia; Post-operative pelvic infection	3 months postoperatively
Secondary	operative time	Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically	During Operation