Rectal Cancer Patientsless stomaNCT07722533
CRP/CT-Guided Selective Ileostomy After LAR
A study testing Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy and routine follow up in people with Rectal Cancer Patients and Anastomotic Leakage, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Patients, Anastomotic Leakage, Low Anterior Resection
- What is being tested?
- Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy and routine follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Stage I disease
- obstructed or perforated tumor
- metastatic or recurrent disease;
- synchronous colonic resection
- total neoadjuvant therapy
- positive intraoperative air-leak test.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria main university hospital
Alexandria, Please Select, 21111
About this study
Official title: Routine Versus Postoperative CRP/CT-Guided Selective Diverting Ileostomy After Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy, routine follow up
- Keywords
- C-reactive protein, Low anterior resection, Colorectal anastomosis, Laparoscopic rectal surgery, Computed tomography
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomyDiagnostic test
Also called laparscopic low anterior resection, 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.
routine follow upDiagnostic test
Also called laparoscopic low anterior resection, ileostomy
routine investigations and follow up
| Study group | Role | What they receive |
|---|---|---|
| Postoperative CRP/CT-Guided Selective Diverting Ileostomy | Experimental | No diverting ileostomy at index laparoscopic LAR. Serum CRP measured daily from postoperative day 1. CT was performed for CRP ≥114 mg/L on postoperative day 3 or a rise >15 mg/L/day thereafter. A diverting loop ileostomy was formed when CT findings were suspicious for anastomotic leakage. Receives: Diagnostic Test: Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy |
| routine protective ileostomy | Active comparator | A diverting loop ileostomy was fashioned at the index laparoscopic LAR after confirmation of an intact anastomosis by intraoperative air-leak testing. Receives: Diagnostic Test: routine follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ileostomy formation within 30 days after surgery
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.
Measured: From index surgery through postoperative day 30
Secondary outcomes (14)
Clinically relevant anastomotic leakage
Grade B or C anastomotic leakage according to International Study Group of Rectal Cancer criteria.
Measured: 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.
Measured: at each postoperative time point
Overall anastomotic leakage
Number and percentage developing grade A, B or C leakage
Measured: within 30 days.
Unplanned rescue ileostomy or colostomy
Number and percentage requiring postoperative stoma formation
Measured: within 30 and 90 days.
Protective ileostomy rate at the index operation
Number and percentage receiving a protective stoma during the initial operation.
Measured: same operation time
Change in CRP concentration
Absolute CRP concentration and percentage change between predefined postoperative days.
Measured: 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
Measured: 30 to 90 ays
Time to diagnosis of anastomotic leakage
Number of days from surgery to confirmed diagnosis.
Measured: 30 to 90 days
Postoperative complications
Complications classified by the Clavien-Dindo system within 30 days.
Measured: within 30 days.
Reoperation rate
Any unplanned abdominal or pelvic reoperation within 30 days. Postoperative mortality
Measured: within 30 days
Postoperative mortality
All-cause mortality within 30 and 90 days.
Measured: within 30 and 90 days.
Length of hospital stay
Number of days from surgery until discharge
Measured: Post operative from 5 to 30 day
Readmission
Unplanned hospital readmission within 30 day
Measured: Unplanned hospital readmission within 30 day
Stoma-free status
Percentage of participants alive without an ileostomy or colostomy at 90 day
Measured: Percentage of participants alive without an ileostomy or colostomy at 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start15 Jan 2023
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722533
- Sponsor's protocol ID
- 0305903
- Acronym
- less stoma
- Status last verified
- Jan 2023
- First submitted
- 17 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moaz AM, Barakat KE, Elshazly W, Zaki Y, Badawy A, Hegazy BK, Mohieldein AM. Routine versus postoperative CRP/CT guided selective diverting ileostomy after laparoscopic low anterior resection for rectal cancer: a comparative randomized controlled trial. BMC Surg. 2026 Oct 14;26(1):687. doi: 10.1186/s12893-026-04248-6.
PubMed 42875765
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus Postoperative CRP/CT-Guided Selective Diverting Ileostomy After Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07722533
- Acronym / sponsor ID
- less stoma / 0305903
- Keywords
- C-reactive protein, Low anterior resection, Colorectal anastomosis, Laparoscopic rectal surgery, Computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative CRP/CT-Guided Selective Diverting Ileostomy | Experimental | Diagnostic Test: Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomyNo diverting ileostomy at index laparoscopic LAR. Serum CRP measured daily from postoperative day 1. CT was performed for CRP ≥114 mg/L on postoperative day 3 or a rise >15 mg/L/day thereafter. A diverting loop ileostomy was formed when CT findings were suspicious for anastomotic leakage. |
| routine protective ileostomy | Active comparator | Diagnostic Test: routine follow upA diverting loop ileostomy was fashioned at the index laparoscopic LAR after confirmation of an intact anastomosis by intraoperative air-leak testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Stage I disease
- obstructed or perforated tumor
- metastatic or recurrent disease;
- synchronous colonic resection
- total neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomyAlso: laparscopic low anterior resection, ileostomyPatients 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 test | Postoperative CRP/CT-Guided Selective Diverting Ileostomy |
| routine follow upAlso: laparoscopic low anterior resection, ileostomyroutine investigations and follow up | Diagnostic test | routine protective ileostomy |
Primary outcome
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.
14 secondary outcomes
Clinically relevant anastomotic leakage
Time frame: within 30 days.
Diagnostic performance of CRP at each postoperative time point
Time frame: at each postoperative time point
Overall anastomotic leakage
Time frame: within 30 days.
Unplanned rescue ileostomy or colostomy
Time frame: within 30 and 90 days.
Protective ileostomy rate at the index operation
Time frame: same operation time
Change in CRP concentration
Time frame: Performed every post operative day from day one up to day 7
Use of computed tomography
Time frame: 30 to 90 ays
Time to diagnosis of anastomotic leakage
Time frame: 30 to 90 days
Postoperative complications
Time frame: within 30 days.
Reoperation rate
Time frame: within 30 days
Postoperative mortality
Time frame: within 30 and 90 days.
Length of hospital stay
Time frame: Post operative from 5 to 30 day
Readmission
Time frame: Unplanned hospital readmission within 30 day
Stoma-free status
Time frame: Percentage of participants alive without an ileostomy or colostomy at 90 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 42875765Moaz AM, Barakat KE, Elshazly W, Zaki Y, Badawy A, Hegazy BK, Mohieldein AM. Routine versus postoperative CRP/CT guided selective diverting ileostomy after laparoscopic low anterior resection for rectal cancer: a comparative randomized controlled trial. BMC Surg. 2026 Oct 14;26(1):687. doi: 10.1186/s12893-026-04248-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy and routine follow up in people with Rectal Cancer Patients and Anastomotic Leakage, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ileostomy formation within 30 days after surgery (time frame: From index surgery through postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07722533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.