Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure
Primary Purpose
Surgical Wound Dehiscence
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TRANSVAGINAL SUTURE
LAPAROSCOPIC SUTURE
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Dehiscence focused on measuring vaginal dehiscence
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy
Exclusion Criteria:
- Patients with gynecological malignancy (uterine and/or adnexal)
Sites / Locations
- Department of Obstetrics and Gynecology Universita' Dell'Insubria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TRANSVAGINAL SUTURE
LAPAROSCOPIC SUTURE
Arm Description
INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders.
INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
VAGINAL CUFF COMPLICATIONS
Vaginal bleeding
Need for Vaginal re-suture
Vaginal vault prolapse
Dyspareunia
Post-operative pelvic infection
operative time
Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically
Full Information
NCT ID
NCT02453165
First Posted
February 3, 2015
Last Updated
March 28, 2018
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT02453165
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Dehiscence
Keywords
vaginal dehiscence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRANSVAGINAL SUTURE
Arm Type
Experimental
Arm Description
INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders.
Arm Title
LAPAROSCOPIC SUTURE
Arm Type
Active Comparator
Arm Description
INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders.
Intervention Type
Procedure
Intervention Name(s)
TRANSVAGINAL SUTURE
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
LAPAROSCOPIC SUTURE
Intervention Description
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
Primary Outcome Measure Information:
Title
VAGINAL DEHISCENCE
Description
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.
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
VAGINAL CUFF COMPLICATIONS
Description
Vaginal bleeding
Need for Vaginal re-suture
Vaginal vault prolapse
Dyspareunia
Post-operative pelvic infection
Time Frame
3 months postoperatively
Title
operative time
Description
Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically
Time Frame
During Operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy
Exclusion Criteria:
Patients with gynecological malignancy (uterine and/or adnexal)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Uccella, MD, PhD
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology Universita' Dell'Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21723030
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.
Results Reference
result
PubMed Identifier
21934442
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.
Results Reference
result
PubMed Identifier
21620360
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.
Results Reference
result
PubMed Identifier
22914459
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.
Results Reference
result
PubMed Identifier
24678487
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.
Results Reference
result
PubMed Identifier
19588344
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.
Results Reference
result
PubMed Identifier
30951920
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.
Results Reference
derived
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Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure
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