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Completed

NCT Number: NCT07722533

CRP/CT-Guided Selective Ileostomy After LAR

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria main university hospital

Alexandria, Please Select, 21111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Other names: laparscopic low anterior resection, ileostomy

routine follow up

Diagnostic Test

routine investigations and follow up

Other names: laparoscopic low anterior resection, ileostomy

Primary outcomes

  1. Ileostomy formation within 30 days after surgery

    Time frame: From index surgery through postoperative day 30

    Number 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 outcomes

  1. Clinically relevant anastomotic leakage

    Time frame: within 30 days.

    Grade B or C anastomotic leakage according to International Study Group of Rectal Cancer criteria.

  2. Diagnostic performance of CRP at each postoperative time point

    Time frame: at each postoperative time point

    Sensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operating characteristic curve.

  3. Overall anastomotic leakage

    Time frame: within 30 days.

    Number and percentage developing grade A, B or C leakage

  4. Unplanned rescue ileostomy or colostomy

    Time frame: within 30 and 90 days.

    Number and percentage requiring postoperative stoma formation

  5. Protective ileostomy rate at the index operation

    Time frame: same operation time

    Number and percentage receiving a protective stoma during the initial operation.

  6. Change in CRP concentration

    Time frame: Performed every post operative day from day one up to day 7

    Absolute CRP concentration and percentage change between predefined postoperative days.

  7. Use of computed tomography

    Time frame: 30 to 90 ays

    Proportion undergoing CT and proportion with CT findings compatible with anastomotic leakage

  8. Time to diagnosis of anastomotic leakage

    Time frame: 30 to 90 days

    Number of days from surgery to confirmed diagnosis.

  9. Postoperative complications

    Time frame: within 30 days.

    Complications classified by the Clavien-Dindo system within 30 days.

  10. Reoperation rate

    Time frame: within 30 days

    Any unplanned abdominal or pelvic reoperation within 30 days. Postoperative mortality

  11. Postoperative mortality

    Time frame: within 30 and 90 days.

    All-cause mortality within 30 and 90 days.

  12. Length of hospital stay

    Time frame: Post operative from 5 to 30 day

    Number of days from surgery until discharge

  13. Readmission

    Time frame: Unplanned hospital readmission within 30 day

    Unplanned hospital readmission within 30 day

  14. Stoma-free status

    Time frame: Percentage of participants alive without an ileostomy or colostomy at 90 day

    Percentage of participants alive without an ileostomy or colostomy at 90 day

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Routine Versus Postoperative CRP/CT-Guided Selective Diverting Ileostomy After Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Controlled Trial

Acronym: less stoma

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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