Mahesh Manilal Vaghela1, J K Mahajan2, Jegadeesh Sundram1, Neerja Bhardwaj3, K L N Rao1. 1. Department of Pediatric Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India. 2. Department of Pediatric Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India. Electronic address: jkmahajan@gmail.com. 3. Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.
Abstract
AIMS: To investigate the role of glycopyrrolate in decreasing oral secretions in patients of esophageal atresia (EA) with anastomotic leak and evaluate its effect on healing of anastomotic dehiscence. METHODS: The study comprised consecutive neonates of esophageal atresia, who had undergone primary surgery and developed anastomotic leak. The patients were randomized into two groups with the observer blinded to the group. The patients in the treatment group were administered glycopyrrolate in the dose of 8 μg/kg 8 hourly, whereas placebo group patients were injected normal saline only. Neonates, in both the groups, were managed conservatively based on the clinical and radiological parameters. The end points of the study were either resolution or progression of the leak. The study was approved by the institute ethics committee. RESULTS: There were 21 patients each in two groups with comparable preoperative characteristics. All the cases had anastomotic leaks clinically detectable in the chest tube. Saliva alone constituted the leak material in 18 cases in the treatment group and 10 in the placebo group. Cumulative total of mean chest tube output per patient for all patients in the treatment group was 124.15ml as compared to 370.27ml in the placebo group (p=0.001). Anastomotic leak stopped in 16 cases (76%) in the treatment group, as compared to 6 cases (29%) in the placebo group (p=0.004). The postoperative ventilation was required in 8 cases (8/21, 38%) in the treatment group and 17 cases (17/21, 81%) in the placebo group (p=0.010). In the treatment group, the diversion procedures were carried out in 2 out of 21 cases (10%), whereas in the placebo group, 52% of the patients (11/21) required such an intervention (p=0.003). At the time of discharge, the oral feeds could be started in 15 cases (15/21, 71%) in the treatment group, as compared to 3 (3/21, 14%) in the placebo group (p=0.0004). CONCLUSIONS: Administration of glycopyrrolate in patients of anastomotic leak after primary repair of esophageal atresia resulted in reduced oral secretions, which helped in healing of the anastomotic dehiscence in a significant number of patients.
RCT Entities:
AIMS: To investigate the role of glycopyrrolate in decreasing oral secretions in patients of esophageal atresia (EA) with anastomotic leak and evaluate its effect on healing of anastomotic dehiscence. METHODS: The study comprised consecutive neonates of esophageal atresia, who had undergone primary surgery and developed anastomotic leak. The patients were randomized into two groups with the observer blinded to the group. The patients in the treatment group were administered glycopyrrolate in the dose of 8 μg/kg 8 hourly, whereas placebo group patients were injected normal saline only. Neonates, in both the groups, were managed conservatively based on the clinical and radiological parameters. The end points of the study were either resolution or progression of the leak. The study was approved by the institute ethics committee. RESULTS: There were 21 patients each in two groups with comparable preoperative characteristics. All the cases had anastomotic leaks clinically detectable in the chest tube. Saliva alone constituted the leak material in 18 cases in the treatment group and 10 in the placebo group. Cumulative total of mean chest tube output per patient for all patients in the treatment group was 124.15ml as compared to 370.27ml in the placebo group (p=0.001). Anastomotic leak stopped in 16 cases (76%) in the treatment group, as compared to 6 cases (29%) in the placebo group (p=0.004). The postoperative ventilation was required in 8 cases (8/21, 38%) in the treatment group and 17 cases (17/21, 81%) in the placebo group (p=0.010). In the treatment group, the diversion procedures were carried out in 2 out of 21 cases (10%), whereas in the placebo group, 52% of the patients (11/21) required such an intervention (p=0.003). At the time of discharge, the oral feeds could be started in 15 cases (15/21, 71%) in the treatment group, as compared to 3 (3/21, 14%) in the placebo group (p=0.0004). CONCLUSIONS: Administration of glycopyrrolate in patients of anastomotic leak after primary repair of esophageal atresia resulted in reduced oral secretions, which helped in healing of the anastomotic dehiscence in a significant number of patients.