NCT07848308

Brief Summary

This study evaluates the clinical outcomes of patients who underwent rectopexy for rectal prolapse, ODS or FI. Rectopexy is a surgical procedure used to restore and fix the rectum in its normal position. The study examines treatment success, recurrence of rectal prolapse, functional outcomes, and postoperative complications. The aim is to better understand the long-term effectiveness and safety of rectopexy and to identify factors that may be associated with favorable or unfavorable outcomes.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
112mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress63%
Jan 2011Dec 2035

Study Start

First participant enrolled

January 1, 2011

Completed
15.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

16 years

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

rectopexyanterior messe rectopexyd'Hoore'sODSintussuseptionrectal prolapse

Outcome Measures

Primary Outcomes (1)

  • Recurrence of symptoms after Rectopexy (ODS, Prolapse, FI)

    Proportion of patients with clinically diagnosed objective recurrence after rectopexy. Recurrence is defined as reappearance of symptoms (as FI, full-thickness external rectal prolapse) during follow-up.

    From surgery until the end of follow-up, up to 10 years

Study Arms (1)

Patients After Rectopexy for Rectal Prolapse

Patients who underwent rectopexy for rectal prolapse, ODS or Fecal Incontinence are included in this observational cohort. Clinical outcomes after surgery are assessed, including symptoms recurrence, recurrence of rectal prolapse, postoperative complications, and functional outcomes. No study-specific intervention is performed. Special subgroups as patients also operated for decent in the middle/anterior compartement might be accessed separately.

Procedure: anterior mesh rectopexy

Interventions

Patients After Rectopexy for Rectal Prolapse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent rectopexy at the participating institution from 2011 onward because of external rectal prolapse, ODS or FI. The study population includes patients with available clinical and postoperative follow-up data allowing assessment of recurrence, postoperative complications, and functional outcomes after rectopexy.

You may qualify if:

  • Adult patients aged 18 years or older Diagnosis of external rectal prolapse, ODS or FI Are planned to undergo rectopexy for rectal prolapse at the participating institution Availability of postoperative follow-up data

You may not qualify if:

  • Age under 18 years No informed consent Insufficient clinical documentation to assess the study outcomes No postoperative follow-up available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOCH Health Ostschweiz Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Rectal ProlapseFecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
120 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant, Department of Surgery

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

January 1, 2011

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2035

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study is based on clinical data collected within the participating institution and no external data-sharing plan has been established. Data will be handled in accordance with applicable ethical, legal, and data protection requirements. If a journal wants to check the data for a publication an anonymised sample of the patient data might be supplied.

Locations