Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional Procedures Following Failed Restrictive Bariatric Surgery: a Prospective Multicenter Study with Three-Year Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Percentage Total Weight Loss (%TWL)
研究概览
简要总结
Study Description
This prospective, multicenter study aims to compare the outcomes of One-Anastomosis Gastric Bypass (OAGB) and Roux-en-Y Gastric Bypass (RYGB) as revisional procedures for patients experiencing insufficient weight loss or weight regain following restrictive bariatric surgeries, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB). Conducted between January 2019 and December 2021, the study involves a three-year follow-up of 328 patients across high-volume bariatric centers.
The primary objective is to evaluate the effectiveness of these revisional procedures in achieving additional weight loss. Secondary objectives include analyzing differences in operative times, complication rates (short- and long-term), reduction of obesity-related comorbidities, mortality, and overall patient outcomes.
This study uniquely integrates comprehensive pre- and postoperative assessments, including radiological evaluations, to better understand predictors of success and provide evidence for optimal surgical strategies in revisional bariatric care.
详细描述
Study Objective and Design
The primary objective of this multicenter study was to compare the effectiveness of one-anastomosis gastric bypass and Roux-en-Y gastric bypass as revisional procedures for addressing insufficient weight loss or weight regain following failed primary restrictive bariatric surgery. Effectiveness was measured in terms of additional weight loss. Secondary objectives included comparisons of surgical duration, reduction in obesity-related comorbidities, rates of short- and long-term complications, and mortality between the two revisional approaches. The study was conducted from January 2019 to December 2021, with a three-year follow-up for each participant.
Patient Selection and Data Collection
Participants were recruited from four high-volume bariatric centers in Italy. Inclusion criteria encompassed adults aged 18 to 65 years who exhibited insufficient weight loss, defined as excess weight loss of less than 50%, total weight loss of less than 25%, or a BMI greater than 40 kg/m² at least two years after undergoing laparoscopic sleeve gastrectomy or laparoscopic adjustable gastric banding. Eligible patients were those requiring revisional surgery exclusively for inadequate weight loss or regain. Exclusion criteria included revisional surgery for other indications (e.g., complications such as stenosis or severe gastroesophageal reflux), untreated psychiatric illness, active eating disorders, pregnancy, or any previous gastric surgery unrelated to bariatric interventions.
Preoperative assessments involved a multidisciplinary team including an endocrinologist, dietitian, and psychologist. Patients identified with maladaptive eating patterns received treatment before surgery to optimize outcomes. Baseline data on demographics, preoperative BMI, and comorbidities were collected and followed up throughout the study. Ethical approval was obtained from all participating centers' medical ethics committees.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years.
- •Experienced insufficient weight loss, defined as:
- •Excess weight loss (EWL) < 50%.
- •Total weight loss (TWL) < 25%.
- •BMI > 40 kg/m² at least two years after primary restrictive surgery.
- •Previously underwent laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB).
- •Undergoing revisional surgery specifically for inadequate weight loss or weight regain.
排除标准
- •Revisional surgery performed for indications other than inadequate weight loss or weight regain (e.g., complications of the primary procedure such as stenosis or refractory gastroesophageal reflux, or for comorbidity management).
- •Known psychiatric illness or untreated eating disorders.
- •Pregnancy.
- •History of prior gastric surgery unrelated to bariatric interventions.
结局指标
主要结局
Percentage Total Weight Loss (%TWL)
时间窗: Measured at 36 months post-surgery.
The percentage of total body weight lost from the pre-revisional weight to the weight at 36 months post-revision.
次要结局
- Percentage Excess BMI Loss (%EBMIL)(Measured at 36 months post-surgery)
- Reduction in Obesity-Related Comorbidities(36 months)
- Complication Rates(36-month follow-up period.)
- Mortality Rate(36 months post-surgery.)
- Quality of Life (QoL) Assessment(36 months post-surgery, months post-surgery months post-surgery)
- Remission of Hypertension (HTN)(Measured at 36, months post-revision.)
- Type 2 Diabetes Mellitus (T2DM)(Assessed at 36 months post-revision)
研究者
Francesco Pizza
Principal Investigator, PhD. MD,
Azienda Sanitaria Locale Napoli 2 Nord