Trial reportObesity surgery2016
Impact of Botulinum Neurotoxin Pyloric Injection During Laparoscopic Sleeve Gastrectomy on Postoperative Gastric Leak: a Clinical Randomized Study.
Trial report in Obesity surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 3 syntheses or guidelines pooled it, 8 citations in OpenAlex.
- Intragastric Botulinum Toxin A Injection Is an Effective Obesity Therapy for Patients with BMI > 40 kg/mObesity surgery · 2020Pooled it
- Comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review.Surgical endoscopy · 2020Pooled it
- Ongoing Inconsistencies in Weight Loss Reporting Following Bariatric Surgery: a Systematic Review.Obesity surgery · 2019Pooled it
- Endoscopic Management of Post-Sleeve Gastrectomy Complications.Journal of clinical medicine · 2024Review
- Revisional Surgeries of Laparoscopic Sleeve Gastrectomy.Diabetes, metabolic syndrome and obesity : targets and therapy · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsConsecutive 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.
resultsOne 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).
conclusionsLSG 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.