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