Role of Serial C-reactive Protein Concentration Analysis With Computed Tomography in Limiting the Need for Protective Defunctioning Ileostomy After Laparoscopic Low Anterior Resection - A Prospective Study (less stoma)

Anastomotic leakage is a clinically important complication following laparoscopic low anterior resection. A protective defunctioning ileostomy may reduce the clinical consequences of leakage but is associated with stoma-related morbidity, dehydration, readmission and the need for a subsequent closure procedure.

This prospective study will evaluate the safety and clinical utility of a standardized postoperative surveillance pathway based on serial serum C-reactive protein measurements and selective computed tomography in patients undergoing laparoscopic low anterior resection in whom routine protective ileostomy is considered potentially avoidable.

Serum C-reactive protein will be measured at predefined postoperative time points. Contrast-enhanced computed tomography, with rectal contrast when clinically appropriate, will be performed when patients meet predefined biochemical or clinical criteria. The study will evaluate successful avoidance of a defunctioning ileostomy, clinically relevant anastomotic leakage, diagnostic performance of serial C-reactive protein, use of computed tomography, time to diagnosis, postoperative morbidity, reoperation, hospital stay and readmission.

Study Overview

• Status: Completed
• Conditions: Anastomotic Leakage; Rectal Cancer Patients; Low Anterior Resection
• Intervention / Treatment: Diagnostic test: Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy; Diagnostic test: routine follow up

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Please Select
    • Alexandria, Please Select, Egypt, 21111
      • Alexandria main university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older.
• Elective laparoscopic low anterior resection.
• Primary colorectal or coloanal anastomosis.
• Diagnosis of [rectal adenocarcinoma / rectal neoplasm / specified benign diseases].
• Anastomosis located [insert distance] cm or less from the anal verge, if applicable.
• Participant considered suitable for omission of routine protective ileostomy according to predefined intraoperative criteria.
• Negative or adequately repaired intraoperative anastomotic leak test.
• Satisfactory anastomotic perfusion according to [clinical assessment/indocyanine green fluorescence].
• Ability to provide written informed consent.
• Agreement to complete postoperative follow-up.

Exclusion Criteria:

• Emergency surgery.
• Abdominoperineal resection or procedure without a colorectal/coloanal anastomosis.
• Planned permanent stoma.
• Pre-existing ileostomy or colostomy.
• Gross intraoperative contamination or generalized peritonitis.
• Positive anastomotic leak test that cannot be satisfactorily repaired.
• Unsatisfactory anastomotic perfusion.
• Major technical difficulty requiring protective diversion according to the protocol.
• Active systemic infection before surgery.
• Chronic inflammatory or autoimmune condition expected to substantially alter CRP concentrations.
• Current long-term systemic corticosteroid or significant immunosuppressive treatment
• Severe renal impairment preventing contrast-enhanced CT, when no suitable alternative imaging pathway is available.
• Known severe allergy to iodinated contrast without an appropriate alternative.
• Pregnancy.
• Inability to comply with postoperative surveillance or follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRP-CT surveillance with selective omission of protective ileostomy; Participants will undergo laparoscopic low anterior resection without routine protective ileostomy when predefined safety criteria are satisfied. Participants will subsequently undergo serial C-reactive protein measurement and selective computed tomography according to the study protocol.	Diagnostic test: Serial 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.; Other Names: laparscopic low anterior resection; ileostomy
Active Comparator: routine protective ileostomy; Participants will undergo laparoscopic low anterior resection with routine protective ileostomy when predefined safety criteria are satisfied.	Diagnostic test: routine follow up; routine investigations and follow up; Other Names: ileostomy; laparoscopic low anterior resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful avoidance of a defunctioning ileostomy without clinically relevant anastomotic leakage	Number and percentage of participants who undergo laparoscopic low anterior resection without a protective ileostomy and remain free from subsequent ileostomy formation and International Study Group of Rectal Cancer grade B or grade C anastomotic leakage.	From the index operation through postoperative day 30.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically relevant anastomotic leakage	Number and percentage of patients developing grade B or C leakage within 30 days.	within 30 days.
Diagnostic performance of CRP at each postoperative time point	Sensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operating characteristic curve.	at each postoperative time point
Overall anastomotic leakage	Number and percentage developing grade A, B or C leakage	within 30 days.
Unplanned rescue ileostomy or colostomy	Number and percentage requiring postoperative stoma formation	within 30 and 90 days.
Protective ileostomy rate at the index operation	Number and percentage receiving a protective stoma during the initial operation.	same operation time
Change in CRP concentration	Absolute CRP concentration and percentage change between predefined postoperative days.	Performed every post operative day from day one up to day 7
Use of computed tomography	Proportion undergoing CT and proportion with CT findings compatible with anastomotic leakage	30 to 90 ays
Time to diagnosis of anastomotic leakage	Number of days from surgery to confirmed diagnosis.	30 to 90 days
Postoperative complications	Complications classified by the Clavien-Dindo system within 30 days.	within 30 days.
Reoperation rate	Any unplanned abdominal or pelvic reoperation within 30 days. Postoperative mortality	within 30 days
Postoperative mortality	All-cause mortality within 30 and 90 days.	within 30 and 90 days.
Length of hospital stay	Number of days from surgery until discharge	Post operative from 5 to 30 day
Readmission	Unplanned hospital readmission within 30 day	Unplanned hospital readmission within 30 day
Stoma-free status	Percentage of participants alive without an ileostomy or colostomy at 90 day	Percentage of participants alive without an ileostomy or colostomy at 90 day

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): June 15, 2026
• Study Completion (Actual): June 15, 2026

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Computed tomography; C-reactive protein; Low anterior resection; Colorectal anastomosis; Laparoscopic rectal surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anastomotic Leak
• Other Study ID Numbers: 0305993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No