Clinical trial NCT04586634: Randomized Clinical Trial on Transanal Irrigation
Official title: Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Anterior Resection Syndrome
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2020-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: LARS Score
timeFrame: Total score measured per subject at study completion after 12 weeks
Secondary outcomes:
measure: Number of Subjects With Major LARS
timeFrame: 12 weeks
measure: FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire
timeFrame: 12 weeks
measure: FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire
timeFrame: 12 weeks
measure: FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire
timeFrame: 12 weeks
measure: FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire
timeFrame: 12 weeks
measure: EQ-5D-5L - Utility Score
timeFrame: 12 weeks
measure: EQ-5D-5L - VAS Score
timeFrame: 12 weeks
measure: Satisfaction With Treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: CHU Nantes, France
name: Guillaume Meurette, MD
role: PRINCIPAL_INVESTIGATOR
References: