Abstract
Background
The most frequent and most feared complication after laparoscopic sleeve gastrectomy (LSG) is gastric leak (GL). We hypothesize that botulinum neurotoxin (botulinum type A (BTX-A)) injection into the pyloric sphincter muscle at the time of operation may decrease the risk of postoperative GL.
Methods
Consecutive patients with morbid obesity (MO) treated by LSG were enrolled. Patients were randomly allocated into two groups: group I (intrapyloric BTX-A injection was performed) and group II (no injection was performed). The primary outcome measure was number of patients developing GL. Secondary outcome measures were percent of excess weight loss, postoperative complications, and their management.
Results
One hundred and fifteen patients (86 (74.8 %) females) were randomized into two groups of 57 patients (group I) and 58 patients (group II). Four patients in group II developed GL versus no patient in group I (P = 0.04). Ten patients in group I and two in group II developed refractory epigastric pain (P = 0.01). Other complication rates were comparable for both groups. Mean preoperative BMI of patients in both groups had significantly decreased from 54.64 ± 6.82 to 42.99 ± 5.3 at 6 months and to 39.09 ± 5.14 at 12 months (P < 0.001).
Conclusions
LSG is an effective, safe, and minimally invasive procedure for treatment of MO. No patient in whom pyloric BTX-A injection was performed developed postoperative GL versus four patients in whom injection was not performed. The difference in GL rate was statistically significant, thus favoring the use of pyloric BTX-A injection during LSG.
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Conflict of Interest
Tamer Youssef declares no conflict of interest.
Emad Abdalla declares no conflict of interest.
Khaled El-Alfy declares no conflict of interest.
Ibrahim Dawoud declares no conflict of interest.
Mosaad Morshed declares no conflict of interest.
Mohamed Farid declares no conflict of interest.
Statement of Informed Consent
Written informed consent was obtained from all patients included in the study after detailed explanation of the purpose of the study.
Additional informed consent was obtained from all individual participants for whom identifying information is included in the study.
A Statement of Human and Animal Rights
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Youssef, T., Abdalla, E., El-Alfy, K. et al. Impact of Botulinum Neurotoxin Pyloric Injection During Laparoscopic Sleeve Gastrectomy on Postoperative Gastric Leak: a Clinical Randomized Study. OBES SURG 26, 494–504 (2016). https://doi.org/10.1007/s11695-015-1794-4
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DOI: https://doi.org/10.1007/s11695-015-1794-4