NCT06271629Completed
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients
Source: ClinicalTrials.gov · Last updated 26 Mar 2024
Brief summary (registry, in English)
The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates. However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications. Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 4 Feb 2024
- Start date
- 26 Feb 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06271629
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 26 Feb 2022 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A history of previous surgery for colorectal cancer
- Concomitant metastatic colorectal cancer
- Chronic constipation or diarrhea not controlled by medication before surgery
- Allergies to the investigational drug
Other illness
- Recurrent colorectal cancer
- Underlying conditions not controlled by medical treatment
- Inflammatory bowel disease
Other
- Requiring permanent colostomy
- Preoperative symptoms of fecal incontinence
- Preoperative symptoms of bowel leakage
- Deemed unsuitable for participation in the clinical trial by the principal investigator and study staff
Who the study is looking for
- undergone low anterior resection for progressive rectal cancer
- undergone bowel continence restoration surgery and are between 1 month and 5 years postoperative
- ability to comprehend and participate in the clinical trial
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.