Rectal ProlapseNORDICNCT05569980
The Nordic Rectal Prolapse Study
An observational study of Rectal Prolapse and Surgery, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse, Surgery, Recurrence
- How many people
- 430 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients getting surgery for external rectal prolapse.
Who may be able to join
- undergoing surgery for rectal prolapse
Who cannot join
- unable to consent to participating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Nordic Rectal Prolapse Study - a Multicentre, International Cohort Study
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
Read the 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.
- Conditions
- Rectal Prolapse, Surgery, Recurrence, Quality of Life
- Keywords
- Surgery, Recurrence, Quality of life, Bowel function
- Medical subject headings
- Rectal Prolapse, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Constipation
To determine the effect of different procedures on constipation symptoms using PAC-SYM score at 6- and 12-months post-operatively.
Measured: 12 months
Faecal incontinence
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.
Measured: 6 months
Complications
To determine rates of short-term harms based on perioperative complications and medium-term follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk Foundation, Esbjerg Hospital - University Hospital of Southern Denmark, Universitätsmedizin Mannheim, Odense University Hospital, Hillerod Hospital, Denmark, Groene Hart Ziekenhuis, ASZ Aalst
- Responsible party
- Principal investigator, Andreea-Alexandra Bach-Nielsen, Aarhus University Hospital
- Investigators
- Peter Christensen, Prof., MDSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569980
- Sponsor's protocol ID
- NORDIC
- Acronym
- NORDIC
- Status last verified
- Jan 2025
- First submitted
- 4 Oct 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nordic Rectal Prolapse Study - a Multicentre, International Cohort Study
- ClinicalTrials.gov ID
- NCT05569980
- Acronym / sponsor ID
- NORDIC / NORDIC
- Conditions
- Rectal Prolapse, Surgery, Recurrence, Quality of Life
- Keywords
- Surgery, Recurrence, Quality of life, Bowel function
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk Foundation, Esbjerg Hospital - University Hospital of Southern Denmark, Universitätsmedizin Mannheim, Odense University Hospital, Hillerod Hospital, Denmark, Groene Hart Ziekenhuis, ASZ Aalst
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients getting surgery for external rectal prolapse.
Key inclusion criteria (1 listed)
- undergoing surgery for rectal prolapse
Key exclusion criteria (1 listed)
- unable to consent to participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Constipation
Time frame: 12 months
Faecal incontinence
Time frame: 6 months
Complications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Christensen, Prof., MDSc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Prolapse and Surgery, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life after surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.