Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Digestive System Diseases

Neoplasms

Syndrome

Parasomnias

Dyssomnias

Low Anterior Resection Syndrome

Rectal Neoplasms

Sleep Initiation and Maintenance Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Sleep Disorders, Intrinsic

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Colonic Diseases

Postoperative Complications

Quality of Life

administered the Insomnia Severity Index (Korean validated version) to patients with Low Anterior Resection Syndrome (LARS) and divided them into two groups based on the severity grade.

The ISI score is a self-report questionnaire consisting of 7 items designed to assess the nature, severity, and impact of insomnia.(16) The typical recall period for respondents is the "last month." The evaluated dimensions include the severity of sleep onset, sleep maintenance, and early morning awakening problems, as well as sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and the distress caused by the sleep difficulties.

Insomnia severity index

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.

1. administer the Low Anterior Resection Syndrome (LARS) questionnaire to patients who underwent low anterior resection surgery for progressive rectal cancer and completed anticancer treatment, with a time lapse of approximately 1 month to 5 years.
2. investigate the use of medication or conservative treatment for managing symptoms of Low Anterior Resection Syndrome.
3. assess whether the symptoms captured in the Low Anterior Resection Syndrome questionnaire primarily occur during the day or night by surveying each of the 5 items in the questionnaire. We determine the overall symptom score by adding up the scores for daytime and nighttime symptoms, selecting the higher score.
4. conduct a survey on the quality of sleep.
5. conduct a survey on the quality of life. compiled the results of the questionnaires and analyze the correlations among them.

Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients

Insomnia Severity Index Score : Sum of Insomnia Severity Index score

Symptoms \& quality of life evaluation in LARS patients

Ministry of Health, Republic of Korea

Seoul National University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients	NCT06271629	Rectal Cancer Low Anterior Re... Insomnia	Insomnia severi...	19 Years -	Seoul National University Hospital
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients	NCT06271629	Rectal Cancer Low Anterior Re... Insomnia	Insomnia severi...	19 Years -	Seoul National University Hospital
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients	NCT06271629	Rectal Cancer Low Anterior Re... Insomnia	Insomnia severi...	19 Years -	Seoul National University Hospital

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