Clinical trial · Interventional
CRP/CT-Guided Selective Ileostomy After LAR
Routine Versus Postoperative CRP/CT-Guided Selective Diverting Ileostomy After Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leakage | — | UNRESOLVED | — |
| Low Anterior Resection | — | UNRESOLVED | — |
| Rectal Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| routine follow up | Diagnostic Test | — | UNRESOLVED |
| Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Postoperative CRP/CT-Guided Selective Diverting Ileostomy
- description
- No diverting ileostomy at index laparoscopic LAR. Serum CRP measured daily from postoperative day 1. CT was performed for CRP ≥114 mg/L on postoperative day 3 or a rise \>15 mg/L/day thereafter. A diverting loop ileostomy was formed when CT findings were suspicious for anastomotic leakage.
- interventionNames
- Diagnostic Test: Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy
- type
- ACTIVE_COMPARATOR
- label
- routine protective ileostomy
- description
- A diverting loop ileostomy was fashioned at the index laparoscopic LAR after confirmation of an intact anastomosis by intraoperative air-leak testing.
- interventionNames
- Diagnostic Test: routine follow up
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available