Alexandria main university hospital
Alexandria, Please Select, 21111, Egypt
NCT Number: NCT07722533
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Alexandria, Please Select, 21111, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 investigations and follow up
Other names: laparoscopic low anterior resection, ileostomy
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.
Time frame: within 30 days.
Grade B or C anastomotic leakage according to International Study Group of Rectal Cancer criteria.
Time frame: at each postoperative time point
Sensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operating characteristic curve.
Time frame: within 30 days.
Number and percentage developing grade A, B or C leakage
Time frame: within 30 and 90 days.
Number and percentage requiring postoperative stoma formation
Time frame: same operation time
Number and percentage receiving a protective stoma during the initial operation.
Time frame: Performed every post operative day from day one up to day 7
Absolute CRP concentration and percentage change between predefined postoperative days.
Time frame: 30 to 90 ays
Proportion undergoing CT and proportion with CT findings compatible with anastomotic leakage
Time frame: 30 to 90 days
Number of days from surgery to confirmed diagnosis.
Time frame: within 30 days.
Complications classified by the Clavien-Dindo system within 30 days.
Time frame: within 30 days
Any unplanned abdominal or pelvic reoperation within 30 days. Postoperative mortality
Time frame: within 30 and 90 days.
All-cause mortality within 30 and 90 days.
Time frame: Post operative from 5 to 30 day
Number of days from surgery until discharge
Time frame: Unplanned hospital readmission within 30 day
Unplanned hospital readmission within 30 day
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
Alexandria University
Other
Routine Versus Postoperative CRP/CT-Guided Selective Diverting Ileostomy After Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Controlled Trial
Acronym: less stoma
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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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