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Enrolling by invitation Observational

The Nordic Rectal Prolapse Study

NCT05569980 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2023-04-01
Last updated
2025-01-23

Condition(s) studied

Rectal ProlapseSurgeryRecurrenceQuality of Life

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: • undergoing surgery for rectal prolapse Exclusion Criteria: • unable to consent to participating

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus N Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05569980 on ClinicalTrials.gov ↗ ← All trials in Denmark