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

NCT06271629 | Completed

• 1 other identifier: 2204-042-1314
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer; Low Anterior Resection Syndrome; Insomnia

Keywords

low anterior resection syndrome; insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  1 Month

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29)

  1 Month

Study Arms (2)

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

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

Interventions

Insomnia severity index DIAGNOSTIC_TEST

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 0&1; Insomnia Severity index Grade 2&3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 22, 2024
• Study Start: February 26, 2022
• Primary Completion: November 30, 2023
• Study Completion: February 29, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)