Treatment of bowel dysfunction after surgery for rectal cancer using transanal irrigation or laxatives

Phase 1

• Conditions: ow Anterior Resection Syndrome; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-001913-17-DK
• Lead Sponsor: Department of Surgery, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 114

Inclusion Criteria

1.Patients electively treated for rectal cancer with a low anterior resection.
2.Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score >29 at evaluation).
3.At least 3 months after surgery (including reversal of a temporary loop-ileostomy).
4.Age > 18 years
5.Ability to understand written and spoken language actual for the including site (due to questionnaire validity).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion Criteria

1.Former use of TAI
2.Anastomotic stenosis
3.History of anastomotic leakage
4.Current metastatic disease or local recurrence
5.Ongoing oncological treatment
6.Postoperative radiotherapy for rectal cancer
7.Previous or current cancer in the pelvic organs
8.Underlying diarrhoeal disease
9.Inflammatory bowel disease
10.Symptom 1 in MYMOP cannot be classified as a LARS symptom
11.Dementia
12.Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.
13.Inability of patient to use TAI
14.Inability and unwillingness to give informed consent
15.Pregnancy or intention to become pregnant during the trial period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified