CRP/CT-Guided Selective Ileostomy After LAR

Overview

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.

Eligible adult patients undergoing elective laparoscopic low anterior resection with primary colorectal or coloanal anastomosis will be prospectively enrolled. Suitability for omission of a protective defunctioning ileostomy will be determined using predefined preoperative and intraoperative criteria, including the condition of the patient, anastomotic integrity, tissue perfusion, technical quality of the anastomosis and the absence of major intraoperative complications. Serum C-reactive protein concentrations will be measured preoperatively and on postoperative days \[insert exact days\]. Computed tomography of the abdomen and pelvis will be requested when one or more of the following occur: C-reactive protein exceeds \[insert threshold\] mg/L on postoperative day \[insert day\]. C-reactive protein fails to decrease by \[insert percentage\] between postoperative days \[insert days\]. There is a persistent or secondary increase in C-reactive protein. The patient develops clinical features suggestive of anastomotic leakage, intra-abdominal infection or postoperative deterioration. Computed tomography will be performed using intravenous contrast and \[oral/rectal contrast when indicated\], unless contraindicated. Subsequent treatment will be based on clinical findings, laboratory results, CT findings and the predefined management protocol. Anastomotic leakage will be classified according to the International Study Group of Rectal Cancer classification, with grade A requiring no active therapeutic intervention, grade B requiring active treatment without relaparotomy, and grade C requiring relaparotomy or major operative intervention.