Randomized Clinical Trial on Transanal Irrigation

NCT ID: NCT04586634

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2021-12-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Peristeen

Subjects to use newly developed Peristeen cone catherter device

Group Type: ACTIVE_COMPARATOR

Peristeen cone catheter

Intervention Type: 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.

Standard of care

subjects continue with their standard of care treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peristeen cone catheter

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Be at least 18 years of age and have full legal Capacity

2. Have given written informed consent

3. Be mental and physical capable to perform transanal irrigation with cone catheter

4. Have a LARS score ≥ 30 after rectal resection

5. Be treated according to individual treatment protocol for conservatory bowel management at participating site

6. Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure

7. At least 3-months from last surgery in colorectum

8. Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure

Exclusion Criteria

1. Active/recurrent colorectal cancer

2. Leaking anastomosis

3. Known anal or colorectal stenosis

4. Within 4 weeks of endoscopic polypectomy

5. Ischaemic colitis

6. Acute inflammatory bowel disease

7. Acute diverticulitis

8. Current or planned pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedPass International

INDUSTRY

Sponsor Role: collaborator

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Meurette, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nantes, France

Locations

Coloplast A/S

Humlebæk, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP327

Identifier Type: -

Identifier Source: org_study_id