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The Nordic Rectal Prolapse Study (NORDIC)

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ClinicalTrials.gov Identifier: NCT05569980
Recruitment Status : Enrolling by invitation
First Posted : October 6, 2022
Last Update Posted : June 23, 2023
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Andreea-Alexandra Bach-Nielsen, Aarhus University Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease
Rectal Prolapse Surgery Recurrence Quality of Life

Detailed Description:

The Nordic Rectal Prolapse Study (NORDIC) is an observational trial initiated from the Pelvic Floor Unit, Aarhus University Hospital (AUH), planned in collaboration with the Pelvic Floor Society, UK. Although an RCT is the most favourable design for interventional surgical trials, it took seven years to recruit 75 patients for an RCT from Aarhus. Observational studies generally recruit with greater ease than RCTs, and this type of design is a valid option to an RCT. The non-randomized design can encourage inclusion as the type of surgery will be as per routine care, and the study is able to adapt to variations in practice during the trial period.

The investigators hypothesize that laparoscopic ventral mesh rectopexy (LVMR) is superior to other surgical procedures for rectal prolapse when it comes to improvement in quality of life for the patients.

Lead site will be the Department of Surgery, AUH. Expression of interest (EoI) forms have been collected from sites in Denmark, Scandinavia, and the UK. Patients undergoing rectal prolapse surgery will be eligible for inclusion respecting a few exclusion criteria. The trial is observational only. Surgical procedure will be by choice of the individual surgeon in collaboration with the patient. Thus, standard practice will be observed at different sites. Due to the high number of participating patients and surgical units, sufficient variation in procedures is assumed.

Quality of life measured by means of EQ-5D (European Quality of Life - 5 Dimensions) at 6 months postoperative will be the primary endpoint. There has been assumed 90% power to demonstrate non-inferiority with a two-sided 95% confidence interval, a non-inferiority margin of 0.1, a standard deviation of 0.26 based on UK population data, and that the correlation between baseline and follow-up EQ-5D is 0.4. Allowing for 10% loss to follow-up the researchers aim to recruit 430 participants in total. A conservative estimate assumes 20 centres with >15 eligible patients per year. With a recruitment rate of 80% the investigators should be able to recruit >480 patients over a 24-months period, allowing for staggered site initiation.

Data will be collected preoperative both from patient records and by patient reported outcome measures (PROMs) covering QoL, bowel function, urinary and sexual function, pain, and global satisfaction, and will be distributed electronically or on paper according to patient preferences.

Main assessment will be PROMs at defined time points.

Study Design
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Study Type : Observational
Estimated Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Nordic Rectal Prolapse Study - a Multicentre, International Cohort Study
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Quality of life after surgery [ Time Frame: 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.


Secondary Outcome Measures :
  1. Constipation [ Time Frame: 12 months ]
    To determine the effect of different procedures on constipation symptoms using PAC-SYM score at 6- and 12-months post-operatively.

  2. Faecal incontinence [ Time Frame: 6 months ]
    To determine the effect of different procedures on faecal incontinence (Wexner Score), MyMOP 2, and on single questions on urinary and sexual function, pain, global satisfaction at 6m.

  3. Complications [ Time Frame: 6 months ]
    To determine rates of short-term harms based on perioperative complications and medium-term follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients getting surgery for external rectal prolapse.
Criteria

Inclusion Criteria:

• undergoing surgery for rectal prolapse

Exclusion Criteria:

• unable to consent to participating

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05569980


Locations
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Denmark
Aarhus University Hospital
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
Novo Nordisk A/S
Investigators
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Principal Investigator: Peter Christensen, Prof., MDSc Aarhus University Hospital
More Information
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Responsible Party: Andreea-Alexandra Bach-Nielsen, Ph.D. student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT05569980    
Other Study ID Numbers: NORDIC
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreea-Alexandra Bach-Nielsen, Aarhus University Hospital:
Surgery
Recurrence
Quality of life
Bowel function
Additional relevant MeSH terms:
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Rectal Prolapse
Recurrence
Prolapse
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
 Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse