Rectal CancerNCT06271629
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients
An observational study of Rectal Cancer and Low Anterior Resection Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rectal Cancer, Low Anterior Resection Syndrome, Insomnia
- What is being tested?
- Insomnia severity index
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone low anterior resection surgery following progressive rectal cancer without permanent stoma
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome, Insomnia
- Being tested
- Insomnia severity index
- Keywords
- low anterior resection syndrome, insomnia
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia severity indexDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Insomnia severity index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Month
Secondary outcomes (2)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Symptoms \& quality of life evaluation in LARS patients
Measured: 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
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start26 Feb 2022
- Primary completion30 Nov 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271629
- Sponsor's protocol ID
- 2204-042-1314
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06271629
- Acronym / sponsor ID
- 2204-042-1314
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome, Insomnia
- Keywords
- low anterior resection syndrome, insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia Severity index Grade 0&1 | – | Diagnostic Test: Insomnia severity indexadministered 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. |
| Insomnia Severity index Grade 2&3 | – | Diagnostic Test: Insomnia severity indexadministered 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone low anterior resection surgery following progressive rectal cancer without permanent stoma
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insomnia severity indexThe 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. | Diagnostic test | Insomnia Severity index Grade 0&1, Insomnia Severity index Grade 2&3 |
Primary outcome
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
2 secondary outcomes
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 1 Month
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29)
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Low Anterior Resection Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS). (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.