Dataset Information

Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after colorectal cancer surgery? Study protocol for a prospective, multicentre, randomized controlled study.

ABSTRACT:

Introduction

The optimal preoperative preparation for elective colorectal cancer surgery has been debated in academic circles for decades. Previously, several expert teams have conducted studies on whether preoperative mechanical bowel preparation and oral antibiotics can effectively reduce the incidence of postoperative complications, such as surgical site infections and anastomotic leakage. Most of the results of these studies have suggested that preoperative mechanical bowel preparation for elective colon surgery has no significant effect on the occurrence of surgical site infections and anastomotic leakage.

Methods/design

This study will examine whether oral antibiotic bowel preparation (OABP) influences the incidence of anastomotic leakage after surgery in a prospective, multicentre, randomized controlled trial that will enrol 1500 patients who require colon surgery. The primary endpoint, incidence of anastomotic leakage, is based on 2.3% in the OABP ± mechanical bowel preparation (MBP) group in the study by Morris et al. Patients will be randomized (1:1) into two groups: the test group will be given antibiotics (both neomycin 1 g and metronidazole 0.9 g) the day before surgery, and the control group will not receive any special intestinal preparation before surgery, including oral antibiotics or mechanical intestinal preparation. All study-related clinical data, such as general patient information, past medical history, laboratory examination, imaging results, and surgery details, will be recorded before surgery and during the time of hospitalization. The occurrence of postoperative fistulas, including anastomotic leakage, will be recorded as the main severe postoperative adverse event and will represent the primary endpoint.

Ethics and dissemination

Ethics approval was obtained from the Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT20200173). The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals. Protocol was revised on November 22, 2021, version 4.0.

Trial registration

ChiCTR2000035550 . Registered on 13 Aug 2020.

SUBMITTER: Gao RQ

PROVIDER: S-EPMC9128219 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after colorectal cancer surgery? Study protocol for a prospective, multicentre, randomized controlled study.

Gao Rui Qi RQ Wang Wei Dong WD Yu Peng Fei PF Mo Zhen Chang ZC Dong Dan Hong DH Yang Xi Sheng XS Li Xiao Hua XH Ji Gang G

Trials 20220523 1

<h4>Introduction</h4>The optimal preoperative preparation for elective colorectal cancer surgery has been debated in academic circles for decades. Previously, several expert teams have conducted studies on whether preoperative mechanical bowel preparation and oral antibiotics can effectively reduce the incidence of postoperative complications, such as surgical site infections and anastomotic leakage. Most of the results of these studies have suggested that preoperative mechanical bowel preparati ...[more]

PMID: 35606865

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Project description:BackgroundPreventive ileostomy (PI) is conventionally performed to prevent anastomotic leakage (AL) after laparoscopic total mesorectal excision (LTME) for low rectal cancer; however, secondary surgery is required to remove the ostomy tube. We designed a new type of ostomy, transcecum catheterization ileostomy (TCI) to prevent AL. Its principle is similar to PI, but no secondary operation is needed. We evaluated the safety and efficacy of TCI in AL prevention.MethodsWe analyzed the data of patients who underwent LTME with low anastomosis in Chongqing University Cancer Hospital from October 2015 to August 2021. Patients were divided into three groups according to their choice: those who underwent TCI (TCI group), those who underwent PI (PI group), and those who undergo none (C group). Intra-operation situation, postoperative efficacy and safety indicators were compared between three groups.ResultsOut of the total 534 patients included, 171 underwent TCI, 156 underwent PI, and 207 underwent none. No statistically difference was noted in baseline characteristics between three groups (all P>0.05). Operation time was longer in TCI group and PI group than in C group (P<0.001). No difference was noted in intraoperative blood loss or the number of lymph nodes dissected (P=0.685 and P=0.153). Moreover, no difference was noted in the serum levels of immune cells on postoperative day 1, 3, and 7 (all P>0.05) or in the levels of serum C-reactive protein (CRP), procalcitonin (PCT), and interleukin 6 (IL-6; all P>0.05). No difference was noted in postoperative incision, pulmonary infection rates and intestinal obstruction incidence (P=0.530, P=0.971, and P=0.938). AL incidence and AL-related reoperation rates were lower in TCI or PI group (P=0.002 and P<0.001). The rate of anastomotic stricture was lower in TCI group than in the other two groups (P<0.001).ConclusionsTCI is effective to prevent AL when performed during LTME. But TCI cannot completely avoid AL. When AL occurs, TCI can reduce the degree of abdominal infection and the secondary surgical rate related AL. TCI presents an alternative option to PI, that does not require secondary operation. Therefore, TCI is safe and worthy of application.

Project description:IntroductionAnastomotic stenosis (AS) is a common complication after colorectal resection. However, the predisposing factors for stricture formation are not fully understood. Previous studies have shown anastomotic leakage (AL) to be a risk factor for the occurrence of AS. Therefore, we aim to investigate the impact of anastomotic leakage characteristics on the occurrence of anastomotic stenosis after colorectal resection.MethodsConsecutive patients with AL following elective, sphincter preserving, colorectal resection, with or without diversion ostomy, between January 2009 and March 2023 were identified from a prospectively collected database. The characteristics of the anastomotic leakage, patient baseline and operative characteristics as well as the postoperative outcomes were analyzed using univariate and multivariate logistic regression to identify factors associated with the occurrence of post-leakage AS.ResultsA total of 129 patients developed AL and met the inclusion criteria. Among these, 28 (21.7%) patients were diagnosed with post-leakage AS. There was a significantly higher frequency of patients with neoadjuvant radiotherapy (18% vs 3%; p = .026) and hand-sewn anastomoses (39% vs 17%; p = .011) within the AS group. Furthermore, the extent of the anastomotic defect was significantly higher in the AS group compared with the non-AS group (50%, IQR 27-71 vs. 20%, IQR 9-40, p = 0.011). Similar findings were observed between the study groups regarding age, sex, BMI, ASA score, medical comorbidities, diagnosis, surgical procedure, surgical approach (open vs. minimally invasive), and anastomotic fashioning (side-to-end vs. end-to-end). On multivariate analysis, the extent of the anastomotic defect (OR 1.01; 95% CI 1.00-1.03; p = 0.034) and hand-sewn anastomoses (OR 2.68; 95% CI 1.01-6.98; p = 0.043) were confirmed as independent risk factors for post-leakage AS. No correlation could be observed between the occurrence of post-leakage AS and the ISREC grading of AL, the anastomotic height or the management of AL. Time to ostomy reversal was significantly longer in the AS group (202d, IQR 169-275 vs. 318d IQR 192-416, p = 0.014).ConclusionThe extent of the anastomotic defect and hand-sewn anastomoses were confirmed as independent risk factors for the occurrence of post-leakage AS. No correlation could be observed between the ISREC grading of AL, the anastomotic height or AL management, and the occurrence of post-leakage AS.

Dataset Information

Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after colorectal cancer surgery? Study protocol for a prospective, multicentre, randomized controlled study.

Introduction

Methods/design

Ethics and dissemination

Trial registration

Publications

Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after colorectal cancer surgery? Study protocol for a prospective, multicentre, randomized controlled study.

Similar Datasets

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