Seoul National University Hospital
Seoul, Jongro-gu, 03080, South Korea
NCT Number: NCT06796296
The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates.
Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life.
Currently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide.
Loperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic.
Transanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection.
However, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the symptoms of LARS syndrome.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
Seoul, Jongro-gu, 03080, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The combination of transanal irrigation (TAI) and Loperamide involves administering Loperamide orally, with a daily dosage of 2mg. This is complemented by the use of TAI, a method in which patients self-administer water into the rectum through an enema, aiming to enhance bowel management and potentially alleviate sysmptoms associated with LARS
Time frame: 4 weeks
Patients are requested to answer the LARS score questionnaires at inclusion (0 week) and 4 weeks after intervention at the outpatient clinic.
The score ranges from 0 to 42, with 0-20 signifying no LARS, 21-29 signifying minor LARS, and 30-42 signifying major LARS.
Only patients with major LARS at 0 week are enrolled. Re-measure the LARS score at week 4 to see the rate of improvement (minor LARS or no LARS) in major LARS in both groups.
Time frame: 4 weeks
A survey is conducted, scoring patient's symptoms related to LARS. It includes the LARS score with night-time symptoms.
Time frame: 4 weeks
A survey is conducted, scoring patient's symptoms related to Insomnia.
Time frame: 4 weeks
A survey is conducted, scoring patient's symptoms related to LARS and quality of life.
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
The Safety and Efficacy of Transanal Irrigation in Patients from Low Anterior Resection Syndrome After Rectal Cancer Surgery : a Multicenter Prospective Randomized Controlled Trial (TraLARS Study)
Acronym: TraLARS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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