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Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Primary Purpose

Vaginal Vault Prolapse, Sexual Function

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
McCall culdoplasty
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaginal Vault Prolapse focused on measuring McCall culdoplasty, Total laparoscopic hysterectomy, Vaginal vault prolapse, Sexual function

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Routine

McCall culdoplasty

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pelvic support
This study will also allow us to collect data regarding differences in POP-Q exams up to 12 months after surgery.
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.

Full Information

First Posted
April 17, 2013
Last Updated
April 16, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01840176
Brief Title
Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
Official Title
Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Vault Prolapse, Sexual Function
Keywords
McCall culdoplasty, Total laparoscopic hysterectomy, Vaginal vault prolapse, Sexual function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine
Arm Type
No Intervention
Arm Description
These women are randomized to receive no McCall culdoplasty at the time of their total laparoscopic hysterectomy.
Arm Title
McCall culdoplasty
Arm Type
Other
Arm Description
The women in this arm are those randomized to undergo a McCall culdoplasty at the time of their total laparoscopic hysterectomy.
Intervention Type
Procedure
Intervention Name(s)
McCall culdoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pelvic support
Description
This study will also allow us to collect data regarding differences in POP-Q exams up to 12 months after surgery.
Time Frame
12 months
Title
Sexual function
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumari Hobbs, MD
Organizational Affiliation
UNC Chapel Hill Dept of OB/GYN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Siedhoff, MD
Organizational Affiliation
UNC Chapel Hill Dept of OB/GYN
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29128440
Citation
Till SR, Hobbs KA, Moulder JK, Steege JF, Siedhoff MT. McCall Culdoplasty during Total Laparoscopic Hysterectomy: A Pilot Randomized Controlled Trial. J Minim Invasive Gynecol. 2018 May-Jun;25(4):670-678. doi: 10.1016/j.jmig.2017.10.036. Epub 2017 Nov 8.
Results Reference
derived

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Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

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