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

NCT05920681 | Unknown

• 1 other identifier: LARSTAI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Anterior Resection Syndrome

Keywords

Low Anterior Resection Syndrome; Transanal irrigation; Fecal Incontinence; Colorectal Surgery; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Proportion of patients for whom transanal irrigation reduced LARS symptom scores

  Assess the proportion of patients with transanal irrigation that reduces the symptoms of LARS.

  1 year

• Proportion of patients for whom best supportive treatment reduced LARS symptom scores

  Assess the proportion of patients with best supportive care that reduces the symptoms of LARS.

  1 year

Study Arms (2)

Transanal irrigation group

EXPERIMENTAL

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.

Procedure: Transanal irrigation

Best supportive care group

ACTIVE COMPARATOR

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).

Combination Product: Best supportive care

Interventions

Transanal irrigation PROCEDURE

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 - d 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.

Transanal irrigation group

Best supportive care COMBINATION_PRODUCT

Diet modification, Loperamidum if needed, diapers, etc.

Best supportive care group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• Tumor recurrence/progression
• Pregnancy
• Diagnosed with inflammatory bowel disease (ICD codes K50-59).
• Side-to-end anastomosis
• Palliative care
• Will not be able to perform irrigation

Sponsors & Collaborators

• National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos: lead

Study Sites (1)

National Cancer Institute

Vilnius, 14186, Lithuania

RECRUITING

Related Publications (1)

• Klimovskij M, Civilka I, Aleinikov A, Aukstikalnis T, Christensen P, Dulskas A. Is transanal irrigation the best treatment possibility for low anterior resection syndrome? A multicenter, randomized clinical trial: study protocol. Front Surg. 2024 May 13;11:1384815. doi: 10.3389/fsurg.2024.1384815. eCollection 2024.

  PMID: 38803549 DERIVED

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Fecal Incontinence

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Audrius Dulskas, PhD

CONTACT

(85) 219 0947; audrius.dulskas@nvi.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: During the research, the name and surname of the subject will be replaced by a special code, according to which it will not be possible to determine the identity of the subject. The subject will be randomly assigned a combination of numbers and/or letters, which will not use the patient's name, surname, initials or other personally identifiable information. This code will be used in all study documents except the consent form. If the law does not provide otherwise, only the doctor conducting the study, the research staff will be able to get acquainted with the confidential data revealing the name and surname.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon (oncologist)

Model Details: Individuals participating in this study will be randomly divided into groups 1 and 2 by randomization. The probability of falling into one or the other group is equal. * Group 1. This is a group of patients who will be subjected to transanal irrigation (experimental). * Group B. This is a group of patients who will receive only the best currently in use maintenance treatment (control).

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: June 27, 2023
• Study Start: June 18, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

LI (1)