Alexandria main university hospital
Alexandria, Please Select, 21111, Egypt
NCT Number: NCT07722533
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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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 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.
Time frame: within 30 days.
Number and percentage of patients developing grade B or C leakage within 30 days.
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
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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