Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01022034

Acronym

Bergamaschi

Enrollment

180

Registered

2009-12-01

Start date

2003-01-31

Completion date

2009-10-31

Last updated

2009-12-02

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

Conditions

Rectal Prolapse

Keywords

Rectal prolapse, mesh, recurrence

Brief summary

No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy. Method: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of \<0.01 was considered significant.

Interventions

PROCEDUREsacral rectopexy with sutures or meshes

PROCEDUREfull rectal mobilization from the sacrum without sacral rectopexy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* informed consent * mental ability to understand the procedure * age range 18 to 70 * both sex

Exclusion criteria

* patients with recurrent rectal prolapse * previous pelvic or colorectal surgery * previous operation for fecal incontinence * Cancer * chronic intestinal Inflammatory diseases

Design outcomes

Primary

Measure	Time frame
long term recurrence of the rectal prolapse	after 5 years

Countries

United States

Outcome results

None listed

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