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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07722533
Acronym
less stoma
Enrollment
200
Registered
2026-07-23
Start date
2023-01-15
Completion date
2026-06-15
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leakage, Low Anterior Resection, Rectal Cancer Patients

Keywords

C-reactive protein, Low anterior resection, Colorectal anastomosis, Laparoscopic rectal surgery, Computed tomography

Brief 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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTSerial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy

Patients undergoing laparoscopic low anterior resection who satisfy predefined criteria for omission of routine protective ileostomy will undergo standardized postoperative surveillance. Serum C-reactive protein will be measured preoperatively and on postoperative days 1,2,3,4,5,6,7\]. Computed tomography of the abdomen and pelvis will be performed when predefined C-reactive protein criteria or clinical warning signs are present. CT findings will be used together with clinical assessment to guide antibiotic treatment, image-guided drainage, endoscopic treatment, reoperation or rescue stoma formation when indicated.

DIAGNOSTIC_TESTroutine follow up

routine investigations and follow up

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

If assessors were genuinely blinded, use Masking: Outcomes Assessor only-rather

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ileostomy formation within 30 days after surgeryFrom index surgery through postoperative day 30Number and percentage of randomized participants who underwent diverting loop ileostomy formation at the index operation or within 30 days after laparoscopic low anterior resection.

Secondary

MeasureTime frameDescription
Clinically relevant anastomotic leakagewithin 30 days.Grade B or C anastomotic leakage according to International Study Group of Rectal Cancer criteria.
Diagnostic performance of CRP at each postoperative time pointat each postoperative time pointSensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operating characteristic curve.
Overall anastomotic leakagewithin 30 days.Number and percentage developing grade A, B or C leakage
Unplanned rescue ileostomy or colostomywithin 30 and 90 days.Number and percentage requiring postoperative stoma formation
Protective ileostomy rate at the index operationsame operation timeNumber and percentage receiving a protective stoma during the initial operation.
Change in CRP concentrationPerformed every post operative day from day one up to day 7Absolute CRP concentration and percentage change between predefined postoperative days.
Use of computed tomography30 to 90 aysProportion undergoing CT and proportion with CT findings compatible with anastomotic leakage
Time to diagnosis of anastomotic leakage30 to 90 daysNumber of days from surgery to confirmed diagnosis.
Postoperative complicationswithin 30 days.Complications classified by the Clavien-Dindo system within 30 days.
Reoperation ratewithin 30 daysAny unplanned abdominal or pelvic reoperation within 30 days. Postoperative mortality
Postoperative mortalitywithin 30 and 90 days.All-cause mortality within 30 and 90 days.
Length of hospital stayPost operative from 5 to 30 dayNumber of days from surgery until discharge
ReadmissionUnplanned hospital readmission within 30 dayUnplanned hospital readmission within 30 day
Stoma-free statusPercentage of participants alive without an ileostomy or colostomy at 90 dayPercentage of participants alive without an ileostomy or colostomy at 90 day

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026