Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Introduction: About 50% of patients who undergo rectal resection (mostly as a treatment for rectal cancer) suffer from various and partly severe functional problems, despite the preservation of the anal fold. These complaints are summarized as low anterior resection syndrome (LARS). So far, there are no randomized clinical trials that would definitively confirm or deny the hypothesis regarding the most effective treatment for LARS.

Objectives: To evaluate whether transanal irrigation improves bowel function and quality of life in patients after rectal resection compared with the best supportive care. Methods and analysis: Patients who have undergone low anterior resection will be approached for this study. During the patient's visit, we will assess their complaints regarding defecation problems, as well as any deterioration in their overall quality of life. To gather this information, we will have the patients fill out questionnaires such as the LARS (Low Anterior Resection Syndrome) and Wexner scale, along with quality of life questionnaires. Questionnaires and scales will be filled out again during the visit every 3 months for 1 year. Discussion: This multicentre, randomized controlled trial will lead to a better understanding of LARS treatment. Moreover, it will be hypothesis generating and inform areas needing future prospective studies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject is an adult (≥ 18 years);

• Agrees to participate in a study;

• A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope);

• \>12 months have passed since the operation or the closure of the ileostomy (if formed);

• No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram);

• LARS \>30 points (major LARS).

Locations
Other Locations
Lithuania
National Cancer Institute
RECRUITING
Vilnius
Contact Information
Primary
Audrius Dulskas, PhD
audrius.dulskas@nvi.lt
(85) 219 0947
Time Frame
Start Date: 2023-06-18
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 40
Treatments
Experimental: Transanal irrigation group
Transanal irrigation will be applied to patients who will enter the experimental group. The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip lubricated with lubricant. The TAI bag is filled with warm water - it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus. The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily.
Active_comparator: Best supportive care group
The control group will receive best supportive care (diet modification, Loperamidum if needed, diapers, etc).~Loperamidum Dosage form: Loperamide Tablets (2mg of loperamide hydrochloride.). Dosage: Initial dose - 2 tablets immediately, then - 1 tablet after each loose stool, but not earlier than 2-3 hours after the initial dose. Do not exceed the maximum daily dose - no more than 6 tablets for adults (maximum daily dose 12 mg).
Related Therapeutic Areas
Sponsors
Leads: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

This content was sourced from clinicaltrials.gov