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

NCT07722533 | Completed DMC

• 1 other identifier: 0305993
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anastomotic Leakage; Low Anterior Resection; Rectal Cancer Patients

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Clinically relevant anastomotic leakage

  within 30 days.

• Diagnostic performance of CRP at each postoperative time point

  at each postoperative time point

• Overall anastomotic leakage

  within 30 days.

• Unplanned rescue ileostomy or colostomy

  within 30 and 90 days.

• Protective ileostomy rate at the index operation

  same operation time

Study Arms (2)

CRP-CT surveillance with selective omission of protective ileostomy

EXPERIMENTAL

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

routine protective ileostomy

ACTIVE COMPARATOR

Participants will undergo laparoscopic low anterior resection with routine protective ileostomy when predefined safety criteria are satisfied.

Diagnostic Test: routine follow up

Interventions

routine follow up DIAGNOSTIC_TEST

routine investigations and follow up

Also known as: laparoscopic low anterior resection, ileostomy

routine protective ileostomy

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.

Also known as: laparscopic low anterior resection, ileostomy

CRP-CT surveillance with selective omission of protective ileostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria main university hospital

Alexandria, Please Select, 21111, Egypt

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 23, 2026
• Study Start: December 15, 2022
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: July 23, 2026

Record last verified: 2022-12

Locations

EG (1)