protocolSection identificationModule nctId: NCT06271629, orgStudyIdInfo id: 2204-042-1314, briefTitle: Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-26, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Ministry of Health, Republic of Korea, descriptionModule briefSummary: 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., conditionsModule conditions: Rectal Cancer, conditions: Low Anterior Resection Syndrome, conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Insomnia severity index, outcomesModule primaryOutcomes measure: Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS)., secondaryOutcomes measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), secondaryOutcomes measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False