Botox application before intragastric balloon placement may improve balloon tolerance but does not change weight loss: A randomized prospective clinical trial

IF 5.2 3区医学 Q1 SURGERY

Asian Journal of Surgery Pub Date : 2026-08-01 Epub Date: 2026-03-30 DOI:10.1016/j.asjsur.2026.03.029

M. Kadir Bartın, Sebahattin Celik, Mahir Coskun, İbrahim Doğan, Ezgi Sönmez, Barzin Tajani, Ayesha Sohail, John W. Boland

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引用次数: 0

Abstract

Aim/background

Gastric balloon application is a common method in obesity management, but early removal remains a challenge. This study aimed to evaluate whether gastric botox (BTX-A) affects balloon tolerance and weight loss.

Methods

A randomized controlled trial was conducted at a tertiary university hospital between January and December 2024. Patients meeting obesity criteria were enrolled and completed the S-36 quality of life questionnaire. They were randomized 1:1 into two groups: the control group received only a 500 cc gastric balloon, while the study group received 200 UI BTX-A, followed by balloon placement after seven days. Rhodex scores were assessed at the 1st hour, 1st day, and 7th day post-insertion. After balloon removal, the S-36 form was repeated. Early balloon removal rates and weight loss after six months were compared.

Results

A total of 140 patients were randomized; however, 10 patients were excluded due to predefined criteria, and ultimately 130 patients were evaluated. Early balloon removal occurred in 4 patients in the control group and 2 in the study group (p = 0.681). While initial Rhodex scores were similar, scores on the 1st and 7th days were significantly lower in the study group (p < 0.001). Readmissions occurred in 9 control and 3 study patients (9.2% total). Quality of life improved in both groups without significant differences. Six-month weight loss was 14.2 kg (study) vs. 14.5 kg (control) (p = 0.865).

Conclusion

BTX-A reduced early balloon removal and hospital readmissions clinically but not statistically. It did not affect weight loss or quality of life.

Registration number

NCT05872932

查看原文本刊更多论文

一项随机前瞻性临床试验：在胃内球囊放置前应用肉毒杆菌素可以改善球囊耐受性，但不会改变体重减轻

目的/背景胃球囊应用是肥胖治疗的常用方法，但早期切除仍然是一个挑战。本研究旨在评估胃肉毒杆菌毒素（BTX-A）是否影响球囊耐受性和体重减轻。方法于2024年1 - 12月在某三级大学附属医院进行随机对照试验。纳入符合肥胖标准的患者，并完成S-36生活质量问卷。他们以1:1的比例随机分为两组：对照组只接受500cc胃球囊，研究组接受200ui BTX-A胃球囊，7天后放置胃球囊。分别于插入后第1小时、第1天和第7天评估Rhodex评分。气球移除后，重复S-36表格。比较早期球囊去除率和6个月后体重减轻率。结果共纳入140例患者；然而，由于预定义的标准，10例患者被排除在外，最终评估了130例患者。对照组早期球囊切除4例，研究组早期球囊切除2例（p = 0.681）。虽然初始Rhodex评分相似，但研究组第1天和第7天的评分明显较低（p < 0.001）。对照组9例，研究组3例（9.2%）再入院。两组患者的生活质量均有改善，但无显著差异。6个月体重减轻14.2 kg（研究组）vs. 14.5 kg（对照组）（p = 0.865）。结论btx - a可减少早期球囊切除和再入院率，但在临床上无统计学意义。它不会影响减肥或生活质量。登记numberNCT05872932

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Asian Journal of Surgery 医学-外科

CiteScore

3.60

自引率

31.40%

发文量

1589

审稿时长

33 days

期刊介绍： Asian Journal of Surgery, launched in 1978, is the official peer-reviewed open access journal of the Asian Surgical Association, the Taiwan Robotic Surgery Association, and the Taiwan Society of Coloproctology. The Journal is published monthly by Elsevier and is indexed in SCIE, Medline, ScienceDirect, Scopus, Embase, Current Contents, PubMed, Current Abstracts, BioEngineering Abstracts, SIIC Data Bases, CAB Abstracts, and CAB Health. ASJSUR has a growing reputation as an important medium for the dissemination of cutting-edge developments in surgery and its related disciplines in the Asia-Pacific region and beyond. Studies on state-of-the-art surgical innovations across the entire spectrum of clinical and experimental surgery are particularly welcome. The journal publishes original articles, review articles, and case reports that are of exceptional and unique importance. The journal publishes original articles, review articles, and case reports that are of exceptional and unique importance.