History of Changes for Study: NCT05569980

The Nordic Rectal Prolapse Study A Multicenter Study of Patients Suffering From Rectal Prolapse. We Aim to Include 430 Participants From Multiple European Countries. The Aim of the Study is to Investigate the Best Surgical Method for Rectal Prolapse. (NORDIC)

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	October 4, 2022	None (earliest Version on record)
2	October 6, 2022	Eligibility, Study Description, Sponsor/Collaborators and Study Status
3	October 11, 2022	Study Status and Study Identification
4	June 22, 2023	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NORDIC
Brief Title:	The Nordic Rectal Prolapse Study A Multicenter Study of Patients Suffering From Rectal Prolapse. We Aim to Include 430 Participants From Multiple European Countries. The Aim of the Study is to Investigate the Best Surgical Method for Rectal Prolapse. (NORDIC)
Official Title:	The Nordic Rectal Prolapse Study - a Multicentre, International Cohort Study
Secondary IDs:

Study Status


Record Verification:	October 2022
Overall Status:	Active, not recruiting
Study Start:	October 1, 2022
Primary Completion:	March 31, 2025 [Anticipated]
Study Completion:	October 1, 2025 [Anticipated]

First Submitted:	October 4, 2022
First Submitted that Met QC Criteria:	October 4, 2022
First Posted:	October 6, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	October 4, 2022
Last Update Posted:	October 6, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Aarhus University Hospital
Responsible Party:	Principal Investigator Investigator: Andreea-Alexandra Bach-Nielsen Official Title: MD Affiliation: Aarhus University Hospital
Collaborators:	Novo Nordisk A/S

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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

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.

We hypothesize that laparoscopic ventral mesh rectopexy (LVMR) is superior to other surgical procedures for rectal prolapse when it comes to improvement in QoL 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. We assume 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 we 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% we 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


Conditions:	Rectal Prolapse Surgery Recurrence Quality of Life
Keywords:	Surgery Recurrence Quality of life Bowel function

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	430 [Anticipated]
Number of Groups/Cohorts	0

Groups and Interventions

Outcome Measures


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


Study Population:	All adult patients getting surgery for external rectal prolapse.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: All patients undergoing surgery for rectal prolapse. Exclusion Criteria: If eligible patients cannot consent to participating.

Contacts/Locations


Study Officials:	Peter Christensen, Prof., MDSc Principal Investigator Aarhus University Hospital
Locations:	Denmark
	Aarhus University Hospital Aarhus N, Denmark, 8200

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: