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Completed

NCT Number: NCT07722533

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

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.

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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

  • 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.

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. Successful avoidance of a defunctioning ileostomy without clinically relevant anastomotic leakage

    Time frame: From the index operation through postoperative day 30.

    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.

Secondary outcomes

  1. Clinically relevant anastomotic leakage

    Time frame: within 30 days.

    Number and percentage of patients developing grade B or C leakage within 30 days.

  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

Acronym: less stoma

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 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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