Clinical trial NCT02453165: Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure
Official title: Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Dehiscence
Keywords: vaginal dehiscence
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 1408
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: VAGINAL DEHISCENCE
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: VAGINAL CUFF COMPLICATIONS
timeFrame: 3 months postoperatively
measure: operative time
timeFrame: During Operation
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Obstetrics and Gynecology Universita' Dell'Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Stefano Uccella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.2011.03.024. Epub 2011 Mar 22.
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 Sep;120(3):516-23. doi: 10.1097/AOG.0b013e318264f848.
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.
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.
citation: 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.