NCT07722533Completed
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 · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 17 Jul 2026
- Start date
- 15 Jan 2023
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- Alexandria University
- Diseases
- Colorectal cancer
- NCT number
- NCT07722533
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 15 Jan 2023 to the primary completion date, 15 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- synchronous colonic resection
- total neoadjuvant therapy
Other illness
- Stage I disease
- metastatic or recurrent disease;
Other
- obstructed or perforated tumor
- positive intraoperative air-leak test.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alexandria main university hospital Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.