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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Low Anterior Resection Syndrome; Rectal Cancer
• Intervention / Treatment: Diagnostic test: Insomnia severity index

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have undergone low anterior resection surgery following progressive rectal cancer without permanent stoma

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• A history of previous surgery for colorectal cancer
• Recurrent colorectal cancer
• Concomitant metastatic colorectal cancer
• Requiring permanent colostomy
• Underlying conditions not controlled by medical treatment
• Inflammatory bowel disease
• Chronic constipation or diarrhea not controlled by medication before surgery
• Preoperative symptoms of fecal incontinence
• Preoperative symptoms of bowel leakage
• Allergies to the investigational drug
• Deemed unsuitable for participation in the clinical trial by the principal investigator and study staff

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Insomnia Severity index Grade 0&1; 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.	Diagnostic test: Insomnia severity index; 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 Grade 2&3; 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.	Diagnostic test: Insomnia severity index; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS).	Insomnia Severity Index Score : Sum of Insomnia Severity Index score	1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Symptoms & quality of life evaluation in LARS patients	1 Month
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29)	Symptoms & quality of life evaluation in LARS patients	1 Month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Health, Republic of Korea

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: insomnia; low anterior resection syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Neoplasms; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Neoplasms by Site; Postoperative Complications; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Syndrome; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Rectal Neoplasms; Low Anterior Resection Syndrome
• Other Study ID Numbers: 2204-042-1314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No