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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McCall culdoplasty | Procedure | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kumari Hobbs, MD | UNC Chapel Hill Dept of OB/GYN | Principal Investigator |
| Matthew Siedhoff, MD | UNC Chapel Hill Dept of OB/GYN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29128440 | Derived | 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. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 months |