TerminatedNot Applicable

Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy

Stopped: Lack of enrollment

United States3 participantsStarted 2021-03-16

Plain-language summary

The primary objective of the proposed study is to determine the difference in surgical time between minimally invasive (laparoscopic) sacrocolpopexy performed with concurrent vaginal hysterectomy versus laparoscopic supracervical hysterectomy. The secondary objectives are to determine if there are differences in intraoperative adverse events and postoperative mesh-related complications and prolapse recurrence between the groups.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18, who are to undergo laparoscopic sacrocolpopexy for uterovaginal prolapse and desire concurrent hysterectomy at the time of surgery * Other concomitant laparoscopic or prolapse and anti-incontinence procedures (cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion. * Patient's must have an up-to-date PAP smear on record, or a PAP smear is performed in the office and verified to be normal pre-enrollment Exclusion Criteria: * Inability to comprehend written and/or spoken English * Inability to provide informed consent * Medical illness precluding laparoscopy * Need for concomitant surgeries not related to pelvic organ prolapse or incontinence * Sacrocolpoperineopexy * Patients desiring uterine preservation (hysteropexy) * Previous apical prolapse surgery (hysteropexy)

What they're measuring

Total Surgical Time - Time of Incision to Time of Sacrocolpopexy Completion

Timeframe: One day intraoperative

Trial details

NCT IDNCT04797585

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-12

Results submitted2023-09-12