This trial is active, not recruiting.

Conditions vaginal vault prolapse, sexual function
Treatment mccall culdoplasty
Sponsor University of North Carolina, Chapel Hill
Start date May 2013
End date June 2014
Trial size 50 participants
Trial identifier NCT01840176, 13-0101


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
(No Intervention)
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.
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.

Primary Outcomes

time frame: 6 months

Secondary Outcomes

Pelvic support
time frame: 12 months
Sexual function
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy
Principal investigator Kumari Hobbs, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.