Anastomotic Leakage, Low Anterior Resection, Rectal Cancer Patients
Conditions
Keywords
C-reactive protein, Low anterior resection, Colorectal anastomosis, Laparoscopic rectal surgery, Computed tomography
Brief 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. 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.
Interventions
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 investigations and follow up
Sponsors
Study design
Masking description
If assessors were genuinely blinded, use Masking: Outcomes Assessor only-rather
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* Stage I disease * obstructed or perforated tumor * metastatic or recurrent disease; * synchronous colonic resection * total neoadjuvant therapy * positive intraoperative air-leak test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ileostomy formation within 30 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant anastomotic leakage | within 30 days. | Grade B or C anastomotic leakage according to International Study Group of Rectal Cancer criteria. |
| Diagnostic performance of CRP at each postoperative time point | at each postoperative time point | Sensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operating characteristic curve. |
| Overall anastomotic leakage | within 30 days. | Number and percentage developing grade A, B or C leakage |
| Unplanned rescue ileostomy or colostomy | within 30 and 90 days. | Number and percentage requiring postoperative stoma formation |
| Protective ileostomy rate at the index operation | same operation time | Number and percentage receiving a protective stoma during the initial operation. |
| Change in CRP concentration | Performed every post operative day from day one up to day 7 | Absolute CRP concentration and percentage change between predefined postoperative days. |
| Use of computed tomography | 30 to 90 ays | Proportion undergoing CT and proportion with CT findings compatible with anastomotic leakage |
| Time to diagnosis of anastomotic leakage | 30 to 90 days | Number of days from surgery to confirmed diagnosis. |
| Postoperative complications | within 30 days. | Complications classified by the Clavien-Dindo system within 30 days. |
| Reoperation rate | within 30 days | Any unplanned abdominal or pelvic reoperation within 30 days. Postoperative mortality |
| Postoperative mortality | within 30 and 90 days. | All-cause mortality within 30 and 90 days. |
| Length of hospital stay | Post operative from 5 to 30 day | Number of days from surgery until discharge |
| Readmission | Unplanned hospital readmission within 30 day | Unplanned hospital readmission within 30 day |
| Stoma-free status | Percentage of participants alive without an ileostomy or colostomy at 90 day | Percentage of participants alive without an ileostomy or colostomy at 90 day |
Countries
Egypt