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NCT Number: NCT06271629

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.

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Key information

Conditions

Rectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Dyssomnias Gastrointestinal Diseases Gastrointestinal Neoplasms Insomnia Intestinal Diseases Intestinal Neoplasms Low Anterior Resection Syndrome Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

  • 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.
  • investigate the use of medication or conservative treatment for managing symptoms of Low Anterior Resection Syndrome.
  • 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.
  • conduct a survey on the quality of sleep.
  • conduct a survey on the quality of life. compiled the results of the questionnaires and analyze the correlations among them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS).

    Time frame: 1 Month

    Insomnia Severity Index Score : Sum of Insomnia Severity Index score

Secondary outcomes

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

    Time frame: 1 Month

    Symptoms & quality of life evaluation in LARS patients

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

    Time frame: 1 Month

    Symptoms & quality of life evaluation in LARS patients

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health, Republic of Korea

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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