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

NCT02453165 | Completed DMC

• 1 other identifier: 440
• Study Type: interventional
• Target: 1,408
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Dehiscence

Keywords

vaginal dehiscence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• VAGINAL CUFF COMPLICATIONS

  3 months postoperatively

• operative time

  During Operation

Study Arms (2)

TRANSVAGINAL SUTURE

EXPERIMENTAL

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

Procedure: TRANSVAGINAL SUTURE

LAPAROSCOPIC SUTURE

ACTIVE COMPARATOR

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

Procedure: LAPAROSCOPIC SUTURE

Interventions

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

TRANSVAGINAL SUTURE

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

LAPAROSCOPIC SUTURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

Location

Related Publications (7)

• 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. 2011 Oct;158(2):308-13. doi: 10.1016/j.ejogrb.2011.05.013. Epub 2011 Jul 1.

  PMID: 21723030 RESULT

• 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.

  PMID: 21934442 RESULT

• 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.2011.03.024. Epub 2011 Mar 22.

  PMID: 21620360 RESULT

• 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 Sep;120(3):516-23. doi: 10.1097/AOG.0b013e318264f848.

  PMID: 22914459 RESULT

• 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.

  PMID: 24678487 RESULT

• 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.

  PMID: 19588344 RESULT

• Uccella S, Capozzi VA, Ricco' M, Perrone E, Zanello M, Ferrari S, Zorzato PC, Seracchioli R, Cromi A, Serati M, Ergasti R, Fanfani F, Berretta R, Malzoni M, Cianci S, Vizza E, Guido M, Legge F, Ciravolo G, Gueli Alletti S, Ghezzi F, Candiani M, Scambia G. Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire. J Minim Invasive Gynecol. 2020 Jan;27(1):186-194. doi: 10.1016/j.jmig.2019.03.018. Epub 2019 Apr 3.

  PMID: 30951920 DERIVED

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Uccella, MD, PhD

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: May 25, 2015
• Study Start: February 1, 2015
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

IT (1)