NCT01840176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

April 17, 2013

Last Update Submit

April 16, 2017

Conditions

Vaginal Vault ProlapseSexual Function

Keywords

McCall culdoplastyTotal laparoscopic hysterectomyVaginal vault prolapseSexual function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pelvic support

    12 months

  • Sexual function

    12 months

Study Arms (2)

Routine

NO INTERVENTION

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

McCall culdoplasty

OTHER

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

Procedure: McCall culdoplasty

Interventions

McCall culdoplastyPROCEDURE

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.

McCall culdoplasty

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 29128440DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kumari Hobbs, MD

    UNC Chapel Hill Dept of OB/GYN

    PRINCIPAL INVESTIGATOR

  • Matthew Siedhoff, MD

    UNC Chapel Hill Dept of OB/GYN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 25, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)