Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062113) titled 'Patient Satisfaction and Quality of Life After Low Anterior Resection Versus Permanent Stoma for Lower Rectal Cancer: A Comparative Study' on Aug. 31.

Study Type: Observational

Primary Sponsor: Institute - Saitama Medical University International Medical Center

Condition: Condition - Lower Rectal Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare postoperative patient satisfaction and quality of life using questionnaire surveys between patients with rectal cancer who underwent low anterior resection and achieved stoma-free status and those with a permanent stoma following abdominoperineal resection or Hartmann's procedure, thereby clarifying the characteristics of each surgical approach from the patient's perspective. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients who provided written informed consent 2.Patients with clinical stage I-III rectal adenocarcinoma 3.Patients who underwent LAR, super-low anterior resection (SLAR), intersphincteric resection (ISR), abdominoperineal resection (APR), or Hartmann's procedure 4.In the LAR group, patients for whom at least 3 months have elapsed since stoma closure 5.In the permanent stoma group, patients for whom at least 1 month has elapsed since surgery 6.Patients who are able to complete the questionnaire 7.Patients aged 18 years or older Key exclusion criteria - 1. Patients with multiple primary cancers, either synchronous or metachronous, with a disease-free interval of <=5 years 2. Patients with recurrent rectal cancer 3. Patients with an active infection 4. Patients with a history of psychiatric disorders and/or central nervous system disorders 5. Patients who are pregnant, breastfeeding, or may be pregnant 6. Patients with severe comorbidities, including cardiopulmonary dysfunction, renal failure, paralytic ileus, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, chronic hepatitis B, or chronic hepatitis C 7. Patients with a history of organ transplantation 8. Patients who are unable to complete the questionnaire because of cognitive impairment or other reasons 9. Patients considered unsuitable for study enrollment by the investigators Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071075

Disclaimer: Curated by HT Syndication.