Study on Improving Bowel Function in Patients with Low Anterior Resection Syndrome Using Glycerol Suppositories or Transanal Irrigation

3 1 1 1

What is this study about?

This clinical trial is focused on helping people who have had surgery for rectal cancer and are experiencing bowel problems afterward, known as Low Anterior Resection Syndrome (LARS). The study is comparing two treatments to see which one works better for improving bowel function and quality of life. One treatment uses glycerol suppositories, which are small, solid forms of medicine inserted into the rectum to help with bowel movements. The other treatment is called transanal irrigation (TAI), a method that involves using water to clean out the lower part of the bowel.

The purpose of the study is to find out if patients who do not see enough improvement with one treatment might benefit more from the other. Participants will first try one of the treatments, and if they do not experience satisfactory improvement, they will switch to the other treatment. The study will monitor changes in bowel function and overall quality of life during this process.

Throughout the study, participants will be asked to report on their symptoms and how they are feeling. This information will help researchers understand which treatment is more effective for managing symptoms of LARS after rectal cancer surgery. The study aims to provide better treatment options for patients dealing with these challenging symptoms.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient has been treated for rectal cancer with a low anterior resection and has experienced unsuccessful treatment for Low Anterior Resection Syndrome (LARS) after at least four weeks.

The patient must be at least three months post-surgery and over 18 years old. Understanding of the language used in the study is required for completing questionnaires.

2 treatment phase with glycerol suppositories

The patient begins treatment with glycerol suppositories, which are administered rectally. The dosage and frequency are determined by the study protocol and are aimed at improving bowel function.

This phase continues until the end of the randomized controlled trial (RCT) period, during which the patient’s bowel function and quality of life (QOL) are monitored.

3 evaluation of treatment effectiveness

At the end of the RCT period, the effectiveness of the glycerol suppositories is evaluated. This involves assessing changes in the main symptom score using the Measure Yourself Medical Outcome Profile (MYMOP) score.

Additional assessments include the LARS Score, the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument, and the St. Mark’s Incontinence Score.

4 alternative treatment phase with transanal irrigation

If the initial treatment with glycerol suppositories does not result in satisfactory improvement, the patient may be switched to transanal irrigation (TAI) as an alternative treatment.

The objective is to determine if TAI provides better improvement in bowel function and QOL compared to glycerol suppositories.

5 final assessment and study completion

The study concludes with a final assessment of the patient’s bowel function and QOL. This includes a comprehensive evaluation using the same scoring systems as before.

The study is estimated to end by August 1, 2026, with all data collected and analyzed to determine the effectiveness of the treatments.

Who Can Join the Study?

Patients who have been treated with surgery for rectal cancer, specifically a type of surgery called low anterior resection.
Patients who have not had successful results from a treatment called PCT (this is a type of therapy) after trying it for at least 4 weeks for a condition known as LARS (Low Anterior Resection Syndrome). This is determined if their LARS score is greater than 29 during evaluation.
Patients must be at least 3 months post-surgery, including the reversal of a temporary procedure called loop-ileostomy (a temporary opening in the belly to allow waste to leave the body).
Patients must be 18 years of age or older.
Patients must be able to understand both written and spoken language used at the study location, as this is important for completing questionnaires.

Who Cannot Join the Study?

Patients who are not experiencing Low Anterior Resection Syndrome cannot participate. This is a condition that affects bowel function after certain surgeries.
Patients who are not within the specified age range cannot participate. The study includes specific age groups, but the exact ages are not provided here.
Patients who are not part of the specified clinical trial group cannot participate. This refers to a specific group of people the study is focusing on.
Patients who are not male or female cannot participate. The study includes both men and women.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Region Midtjylland	Aarhus	Denmark
Rflcly Ndltktashyn	Aalborg	Denmark
Hoefsm Hzafkggb	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.08.2019

Trial locations

Investigated drugs:

Glycerol

Glycerol Suppositories are used to help relieve constipation. They work by drawing water into the bowel, which softens the stool and makes it easier to pass. In this trial, they are being used to see if they can improve bowel function and quality of life in patients with Low Anterior Resection Syndrome.

Transanal Irrigation (TAI) is a procedure used to help empty the bowel. It involves introducing water into the bowel through the anus using a special device. This helps to stimulate the bowel to empty. In this trial, TAI is being tested to see if it can improve bowel function and quality of life in patients who have not had satisfactory results with other treatments.

Investigated diseases:

Low anterior resection syndrome

Low Anterior Resection Syndrome – This condition occurs after surgical removal of the lower part of the rectum, often due to cancer. It affects bowel function, leading to symptoms such as frequent bowel movements, urgency, and incontinence. Patients may also experience difficulty in controlling gas and stool, as well as a sensation of incomplete evacuation. The syndrome can significantly impact the quality of life, causing discomfort and social embarrassment. Symptoms can vary in intensity and may change over time. The condition is a result of changes in bowel anatomy and nerve function following surgery.

Trial ID:

2024-519492-25-01

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider