NCT03034499

Brief Summary

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:

  1. 1.Via single-port.
  2. 2.Via multi-port.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1.6 years

First QC Date

January 25, 2017

Last Update Submit

June 9, 2019

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Comparison of surgical time

    Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.

    Up to four months (2 weeks before surgery until 3 months post-surgery).

Secondary Outcomes (2)

  • Comparison of surgical success

    Up to four months (2 weeks before surgery until 3 months post-surgery).

  • Comparison of surgical complications

    Up to four months (2 weeks before surgery until 3 months post-surgery).

Study Arms (2)

Single-port sacrocolpopexy

ACTIVE COMPARATOR

Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.

Procedure: Single-port sacrocolpopexy

Multi-port sacrocolpopexy

ACTIVE COMPARATOR

Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.

Procedure: Multi-port sacrocolpopexy

Interventions

Single-port sacrocolpopexyPROCEDURE

Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

Single-port sacrocolpopexy
Multi-port sacrocolpopexyPROCEDURE

Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

Multi-port sacrocolpopexy

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.

You may not qualify if:

  • Patients after previous hysterectomy.
  • Patients after previous surgical procedures for prolapse repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Related Publications (1)

  • Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.

    PMID: 31589864DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

March 20, 2017

Primary Completion

November 1, 2018

Study Completion

April 1, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)