Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03034499

Enrollment

Registered

2017-01-27

Start date

2017-03-20

Completion date

2019-04-01

Last updated

2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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

Detailed description

One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy: 1. Via single-port. 2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined. Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications. Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.

Interventions

PROCEDURESingle-port sacrocolpopexy

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

PROCEDUREMulti-port sacrocolpopexy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of surgical time	Up to four months (2 weeks before surgery until 3 months post-surgery).	Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.

Secondary

Measure	Time frame	Description
Comparison of surgical success	Up to four months (2 weeks before surgery until 3 months post-surgery).	Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.
Comparison of surgical complications	Up to four months (2 weeks before surgery until 3 months post-surgery).	Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026