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Completed NCT07722533

CRP/CT-Guided Selective Ileostomy After LAR

Conditions: Rectal Cancer Patients, Anastomotic Leakage, Low Anterior Resection

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Alexandria University

Location: Alexandria main university hospital Alexandria Please Select

Summary

This single-center, parallel-group randomized controlled trial compared routine diverting loop ileostomy with a postoperative CRP/CT-guided selective ileostomy strategy in adults undergoing laparoscopic low anterior resection for stage II or III middle or lower rectal cancer after long-course chemoradiotherapy. Participants were randomized 1:1 after a negative intraoperative air-leak test. In the selective-strategy group, no ileostomy was created at the index operation; CRP was measured daily from postoperative day 1. A CRP concentration of at least 114 mg/L on postoperative day 3 or a subsequent rise of more than 15 mg/L/day triggered contrast-enhanced abdominopelvic CT. A diverting ileostomy was created when CT findings were suspicious for anastomotic leakage. The routine group received a diverting loop ileostomy during the index operation. The primary outcome was ileostomy formation within 30 days. Secondary outcomes included anastomotic leakage, postoperative morbidity, stoma-related morbidity, CT use, hospital stay, time to stoma reversal, and health-related quality of life.

Eligibility Criteria

Inclusion criteria: * Adults with primary resectable stage II or III middle- or lower-third rectal adenocarcinoma planned for laparoscopic low anterior resection with total mesorectal excision * completion of long-course neoadjuvant chemoradiotherapy * negative intraoperative air-leak test after anastomosis. Exclusion criteria: * Stage I disease * obstructed or perforated tumor * metastatic or recurrent disease; * synchronous colonic resection * total neoadjuvant therapy * positive intraoperative air-leak test.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07722533). StuddyBuddy aggregates publicly available trial information.