Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

University of North Carolina (UNC)

Status: Completed

Conditions: Sexual Function; Vaginal Vault Prolapse

Treatments: Procedure: McCall culdoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01840176

13-0101

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Routine

No Intervention group

Description:

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

McCall culdoplasty

Other group

Description:

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

Treatment:

Procedure: McCall culdoplasty