Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01840176|
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : April 18, 2017
The purpose of this study is to assess the feasibility of performing prophylactic McCall culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be measuring pelvic support (using POP-Q) and sexual function before and at different time points (up to 12 months) postoperatively.
The investigators hypothesize that women undergoing the McCall culdoplasty will not have different immediate surgical outcomes (operative time, etc) and may have better pelvic support and sexual function in the future.
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Vault Prolapse Sexual Function||Procedure: McCall culdoplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: Routine
These women are randomized to receive no McCall culdoplasty at the time of their total laparoscopic hysterectomy.
The women in this arm are those randomized to undergo a McCall culdoplasty at the time of their total laparoscopic hysterectomy.
Procedure: McCall culdoplasty
The modified McCall Culdoplasty procedure is a relatively simple procedure that is performed after removal of the uterus and cervix from the apex of the vagina wherein the angles of the vagina are attached to their respective uterosacral ligament and the cul-de-sac is surgically obliterated for support postoperatively. This is done with a single 0-vicryl suture. There will be no additional interventions applied during the hysterectomy aside from the McCall culdoplasty.
- Feasibility [ Time Frame: 6 months ]The primary aim of the study is to generate feasibility data for performing a powered randomized trial on prophylactic modified McCall's culdoplasty during benign total laparoscopic hysterectomy. As such, we will measure operative time with the hypothesis that the intervention does not add significant additional effort. We will also collect information regarding patient willingness to participate as well as intra- and post-operative complication data.
- Pelvic support [ Time Frame: 12 months ]This study will also allow us to collect data regarding differences in POP-Q exams up to 12 months after surgery.
- Sexual function [ Time Frame: 12 months ]We will also collect data regarding sexual function at different time points pre and postoperatively up to 12 months after surgery using the validated Female Sexual Function Index (FSFI) questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840176
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Kumari Hobbs, MD||UNC Chapel Hill Dept of OB/GYN|
|Study Director:||Matthew Siedhoff, MD||UNC Chapel Hill Dept of OB/GYN|