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A study of botulinum toxin type A versus placebo to treat bowel movement problems in patients recovering from surgery for rectal cancer

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What is this study about?

This study focuses on individuals who have undergone a surgical procedure called restorative total mesorectal excision (TME) to treat rectal cancer. A common complication following this surgery is Low Anterior Resection Syndrome (LARS), a condition that causes issues with bowel control, such as fragmented defecation, which is when a person cannot fully empty their bowels in one sitting, and urgency, which is a sudden, strong need to have a bowel movement. These symptoms are often caused by damage to the nerves that control the muscles in the colon.

The purpose of the study is to determine if injecting botulinum toxin type a into the wall of the colon can help reduce these symptoms. Botulinum toxin type a is a substance that works by relaxing the smooth muscle, which are the muscles in the body that move automatically to push waste through the digestive tract. During the study, some participants will receive the botulinum toxin type a via injection, while others will receive a placebo.

Participants will be monitored over a period of several months to observe changes in their bowel habits and symptoms. This includes assessing the frequency of bowel movements and the level of urgency experienced. The effects of the treatment will be tracked at different stages following the injections to see how much the symptoms improve compared to the group receiving the placebo.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must provide voluntary written informed consent, which means you or your legal representative must sign a document agreeing to participate after being fully informed about the study.
  • You must be scheduled for an elective restorative total mesorectal excision. This is a planned surgery to remove the rectum and the surrounding fatty tissue to treat rectal cancer.
  • You must use a highly effective method of birth control, such as implants, certain pills, or other reliable ways to prevent pregnancy, to ensure a very low chance of pregnancy during the study.

Who Cannot Join the Study?

  • You have had a partial mesorectal excision (a surgery where only part of the tissue around the rectum is removed) or a local excision (removal of a small area of tissue).
  • You have undergone a resection beyond TME (a type of surgery that removes more tissue than the standard procedure for rectal cancer).
  • You have a tumor classified as T4 that required a pelvic exenteration (a major surgery to remove organs from the pelvic area).
  • You have Inflammatory Bowel Disease, which is a condition causing long-term swelling and irritation in the digestive tract.
  • You are pregnant, breastfeeding, planning to become pregnant, or are able to become pregnant and are not using highly effective contraception (methods to prevent pregnancy).
  • You are currently participating in another medical study that uses a new investigational medicinal product (an experimental drug) or a new medical device.
  • You have a stoma, which is an opening created surgically that allows waste to leave the body through a bag.
  • You have a known hypersensitivity (an allergic reaction) to botulinum toxin type A or any of its excipients (the inactive substances used to make the medicine).
  • You have an infection at the area where the injection is planned.
  • You have a neuromuscular junction disorder, which is a condition that interferes with how your nerves communicate with your muscles; examples include myasthenia gravis or Lambert-Eaton syndrome.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.03.2026

Trial locations

Investigated drugs:

Botulinum toxin type A is a medication injected into the colon to help relax the muscles in the digestive tract. It works by blocking the signals that cause muscles to contract too strongly or too often, which may help reduce issues with bowel urgency and abnormal movements after surgery.

Investigated diseases:

Rectal Cancer – This is a type of cancer that begins in the tissues of the rectum, which is the last part of the large intestine. It typically develops from abnormal cell growth in the lining of the rectal wall. As the disease progresses, these abnormal cells can form tumors that may grow into deeper layers of the rectal tissue. If left unchecked, the cancer cells can spread to nearby structures or distant parts of the body. This condition is categorized under both digestive system diseases and neoplasms.

Trial ID:
2025-524342-96-00
Trial Phase:
Therapeutic exploratory (Phase II)

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