NCT05569980

Brief Summary

The goal of this observational study is to gather data about surgical procedures for rectal prolapse in adult human subjects. The main question it aims to answer is:

  • Which procedure is best for treating external rectal prolapse? Participants will:
  • be included if they can consent to participation
  • be offered standard care treatment, as no interventions will be done
  • be asked to answer relevant questionnaires within 3 months prior to the surgery for rectal prolapse
  • be asked to answer the same questionnaires 6 and 12 months postoperative
  • optionally answer the questionnaires again at 3 and 1 year postoperative, but this is not part of the existing funding body

Trial Health

75
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress74%
Apr 2023May 2027

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

October 4, 2022

Last Update Submit

January 21, 2025

Conditions

Rectal ProlapseSurgeryRecurrenceQuality of Life

Keywords

SurgeryRecurrenceQuality of lifeBowel function

Outcome Measures

Primary Outcomes (1)

  • Quality of life after surgery

    To determine whether well-established procedures for external rectal prolapse are non-inferior to LVMR using EQ-5D at 6 months post-surgery.

    6 months

Secondary Outcomes (3)

  • Constipation

    12 months

  • Faecal incontinence

    6 months

  • Complications

    6 months

Eligibility Criteria

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

All adult patients getting surgery for external rectal prolapse.

You may qualify if:

  • undergoing surgery for rectal prolapse

You may not qualify if:

  • unable to consent to participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Rectal ProlapseRecurrence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Peter Christensen, Prof., MDSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. student

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

April 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)