Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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.

Official Title
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Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

Conditions
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Vaginal Vault Prolapse, Sexual Function

Intervention / Treatment
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* Procedure: McCall culdoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine<br>These women are randomized to receive no McCall culdoplasty at the time of their total laparoscopic hysterectomy. | |
| Other: McCall culdoplasty<br>The women in this arm are those randomized to undergo a McCall culdoplasty at the time of their total laparoscopic hysterectomy. | Procedure: McCall culdoplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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McCall culdoplasty, Total laparoscopic hysterectomy, Vaginal vault prolapse, Sexual function