Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Vaginal Vault Prolapse Clinical Trial

Official title:

Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840176
• Other study ID #: 13-0101
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: April 16, 2017
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Sexual Function
• Vaginal Vault Prolapse

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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.	6 months
Secondary	Pelvic support	This study will also allow us to collect data regarding differences in POP-Q exams up to 12 months after surgery.	12 months
Secondary	Sexual function	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.	12 months