Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271629
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2024-02-04
Brief Title:
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None