Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT01840176

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Actual Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Routine These women are randomized to receive no McCall culdoplasty at the time of their total laparoscopic hysterectomy.
Other: McCall culdoplasty 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.

Arm

Intervention/Treatment

No Intervention: Routine

These women are randomized to receive no McCall culdoplasty at the time of their total laparoscopic hysterectomy.

Other: McCall culdoplasty

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.

Outcome Measures

Primary Outcome Measures

Feasibility [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.

Secondary Outcome Measures

Pelvic support [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women aged 18-99 undergoing elective laparoscopic hysterectomy for benign indications with surgeons in the division of Advanced Laparoscopy and Pelvic Pain at UNC-Chapel Hill.

Exclusion Criteria:

Current symptomatic or asymptomatic pelvic organ prolapse as measured by the Pelvic Organ Prolapse Quantification (POPQ) system.
Pregnancy
Non-English speaking
Unable to provide informed consent
Pathology causing an obliterated cul-de-sac