Randomized Clinical Trial on Transanal Irrigation

NCT04586634 | Completed Results

• 1 other identifier: CP327
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care. The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter. Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy. The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site. Primary endpoint and secondary endpoints Primary endpoint:

• LARS score, obtained from the LARS score questionnaire\* Secondary endpoints:
• Number of subjects with Major LARS\*
• FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\*
• FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\*
• FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\*
• FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\*
• EQ-5D-5L - utility score\*
• EQ-5D-5L - VAS score (scale 0-10 cm)\*
• Satisfaction with treatment (scale 0-10 cm)\*
• Number of adverse events\* \*All endpoints are measured per subject at study completion

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

• LARS Score

  Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.

  Total score measured per subject at study completion after 12 weeks

Secondary Outcomes (8)

• Number of Subjects With Major LARS

  12 weeks

• FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire

  12 weeks

• FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire

  12 weeks

• FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire

  12 weeks

• FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire

  12 weeks

Study Arms (2)

Peristeen

ACTIVE COMPARATOR

Subjects to use newly developed Peristeen cone catherter device

Device: Peristeen cone catheter

Standard of care

NO INTERVENTION

subjects continue with their standard of care treatment

Interventions

Peristeen cone catheter DEVICE

The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.

Peristeen

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age and have full legal Capacity
• Have given written informed consent
• Be mental and physical capable to perform transanal irrigation with cone catheter
• Have a LARS score ≥ 30 after rectal resection
• Be treated according to individual treatment protocol for conservatory bowel management at participating site
• Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
• At least 3-months from last surgery in colorectum
• Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure

You may not qualify if:

• Active/recurrent colorectal cancer
• Leaking anastomosis
• Known anal or colorectal stenosis
• Within 4 weeks of endoscopic polypectomy
• Ischaemic colitis
• Acute inflammatory bowel disease
• Acute diverticulitis
• Current or planned pregnancy

Sponsors & Collaborators

• Coloplast A/S: lead
• MedPass International: collaborator

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Strategy
• Organization: Coloplast

clinical-studies@coloplast.com

+4549111111

Study Officials

• Guillaume Meurette, MD

  CHU Nantes, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: January 21, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)