Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Sexual Function; Vaginal Vault Prolapse
• Interventions: Procedure: McCall culdoplasty

• Registration Number: NCT01840176
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Study Start: 2013-05
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-16
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McCall culdoplasty	McCall culdoplasty	The women in this arm are those randomized to undergo a McCall culdoplasty at the time of their total laparoscopic hysterectomy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States