NCT04797585

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

March 10, 2021

Results QC Date

September 12, 2023

Last Update Submit

April 23, 2024

Conditions

Vaginal HysterectomyLaparoscopic Supracervical Hysterectomy

Outcome Measures

Primary Outcomes (1)

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

    Completion = time of abdominal incisions closed

    One day intraoperative

Secondary Outcomes (7)

  • Post-operative Mean Difference PFDI-20 at 24 Months

    24 months

  • Post-operative Mean Difference ISI at 24 Months

    24 months

  • Post-operative Mean Difference PGII at 24 Months

    24 months

  • Post-operative Mean Difference PISQ-12 at 24 Months

    24 months

  • Postoperative Subjective Recurrence at 24 Months

    24 months

  • +2 more secondary outcomes

Study Arms (2)

Laparoscopic supracervical hysterectomy

ACTIVE COMPARATOR

Minimally invasive procedure to remove a woman's uterus

Other: Laparoscopic supracervical hysterectomy

Vaginal hysterectomy

EXPERIMENTAL

Surgical procedure to remove the uterus

Other: Vaginal hysterectomy

Interventions

Laparoscopic supracervical hysterectomyOTHER

Laparoscopic supracervical hysterectomy

Laparoscopic supracervical hysterectomy
Vaginal hysterectomyOTHER

Vaginal hysterectomy

Vaginal hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing hysterectomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Nassif J, Yadav GS, Orejuela FJ, Turrentine MA. Rate of Mesh Erosion After Sacrocolpopexy With Concurrent Supracervical Compared With Total Hysterectomy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2022 Sep 1;140(3):412-420. doi: 10.1097/AOG.0000000000004901. Epub 2022 Aug 3.

    PMID: 35926201DERIVED

MeSH Terms

Interventions

Hysterectomy, Vaginal

Intervention Hierarchy (Ancestors)

HysterectomyGynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Cecile Ferrando, M.D.
Organization
Cleveland Clinic Foundation
ferranc2@ccf.org
216-444-0642

Study Officials

  • Cecile Ferrando, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

March 16, 2021

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)