Single Anastomosis Plication Ileal Bypass Versus Single Anastomosis Sleeve Ileal Bypass in the Management of Morbid Obesity, a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
研究概览
简要总结
Study Design A single-center cohort study combining prospective and retrospective data collection was conducted. The prospective arm enrolled consecutively admitted patients, while the retrospective arm analyzed previously recorded cases meeting identical eligibility criteria.
Study Setting and Population
The study was performed at the General Surgery Department, Faculty of Medicine, Mansoura University. It included adults aged 18-65 years with morbid obesity eligible for bariatric surgery:
- Body mass index (BMI) ≥ 35 kg/m² with obesity-related comorbidities, or
- BMI 30-34.9 kg/m² with at least one major comorbidity [e.g., type 2 diabetes mellitus (T2DM), hypertension (HTN), obstructive sleep apnea (OSA), dyslipidemia, osteoarthritis (OA), and gastroesophageal reflux disease (GERD)] Study Period
- Prospective: September 2021 - September 2023
- Retrospective: January 2017 - August 2021 Eligibility Criteria Included patients were American Society of Anesthesiology (ASA) class I-III and had failed structured non-surgical weight management for ≥6 months.
Exclusion criteria included endocrine obesity, prior bariatric surgery, severe psychiatric or cognitive disorders, substance abuse, pregnancy, and previous major upper abdominal surgery.
Sample Size
Sample size was calculated based on cost difference between SASI and SAPI procedures using a two-sample means formula. A clinically relevant difference of 500 USD and SD of 700 USD were assumed, yielding:
- Total of 62 patients in the entire cohort
- Adjusted for 10% attrition → 70 total patients Final allocation was approximately 2:1 single anastomosis sleeve ileal bypass (SASI) : single anastomosis plication ileal bypass (SAPI), reflecting real-world recruitment rather than randomization.
Group Allocation Non-randomized assignment was used. Prospective allocation involved shared decision-making within a multidisciplinary team, while retrospective allocation was based on prior surgical records. Influencing factors included cost, availability, insurance, and patient preference.
________________________________________ Methods Preoperative Assessment
Comprehensive evaluation included:
- Detailed medical history and comorbidity assessment
- Nutritional deficiency screening and correction
- Anthropometric measurements
- Laboratory tests
- Imaging (as indicated) Validated Questionnaires
- Physical activity: using The Rapid Assessment of Physical Activity (RAPA)
- Eating behavior: Self-Regulation of Eating Behavior Questionnaire (SREB-Q) and The Eating Attitudes Test (EAT-26)
- Sleep quality: The Pittsburgh Sleep Quality Index (PSQI)
- Socioeconomic status: Fahmy & El-Sherbini scale
- Quality of life (QoL): The Moorehead-Ardelt Quality of Life Questionnaire II (MA-QoL II)
Surgical Procedures
Two laparoscopic techniques were performed:
SASI
- Sleeve gastrectomy over 36-Fr bougie
- 300 cm ileal loop anastomosed to gastric antrum
- Stapled side-to-side stapled gastroileal anastomosis SAPI
- Same, but gastric devascularization and plication over a 36-Fr bougie rather than sleeve gastrectomy Both procedures included leak testing, drain placement, and dual-outlet gastric configuration.
Postoperative Management
Standardized enhanced recovery protocol:
- Early mobilization and VTE prophylaxis
- Proton pump inhibitors and analgesia
- Gradual oral intake from postoperative day 1
- Imaging and lab assessment when indicated
- Early discharge if stable
Cost Analysis
A micro-costing approach was used, including:
- Primary costs: technology, personnel, instruments, disposables, hospitalization, follow-up, supplements
- Secondary costs: readmissions and re-interventions Cost components were calculated using standardized formulas for each item Total cost = Primary + Secondary costs
Cost-effectiveness was evaluated using:
- Cost-effectiveness ratios (CER)
- Incremental cost-effectiveness ratio (ICER)
- Outcomes included percentage of excess weight loss (%EWL), complication rates, readmission, comorbidity remission, and The Bariatric Analysis and Reporting Outcome System (BAROS).
Follow-Up and Outcomes
Follow-up included:
- Weekly (1st month), biweekly (next 2 months), then quarterly (up to 1 year)
- Assessment of weight loss, comorbidities, complications, and QoL
Primary outcome:
• Total cost difference between SASI and SAPI
Secondary outcomes:
- Operative time, length of hospital stay, complications
- %EWL, comorbidity remission
- QoL (MA-QoL II, BAROS)
Statistical Analysis
Performed using SPSS v26:
- Normality: Shapiro-Wilk test
- Continuous data: t-test or Mann-Whitney U
- Categorical data: Chi-square or Fisher's test
- Regression: linear and logistic models
- Significance set at p < 0.05.
详细描述
Study design This study was designed as a single-center cohort study incorporating both prospective and retrospective components. The prospective arm involved the forward collection of data from consecutively enrolled patients, while the retrospective arm included the analysis of previously recorded data from patients meeting the same eligibility criteria.
Study Setting The study was conducted at the General Surgery Department, Faculty of Medicine, Mansoura University. It included patients presenting with obesity eligible for metabolic and bariatric surgery, defined as body mass index (BMI) ≥ 35 kg/m² regardless of the presence of obesity-related comorbidities. Patients with BMI 30-34.9 kg/m² were included only if associated with at least one obesity-related comorbidity, particularly type 2 diabetes mellitus (T2DM), hypertension (HTN), obstructive sleep apnea (OSA), dyslipidemia, and osteoarthritis (OA), gastroesophageal reflus disease (GERD).
Study Period The study incorporated both prospective and retrospective components. The prospective phase enrolled patients admitted between September 2021 and September 2023, or until attainment of the target sample size. Additionally, a retrospective analysis was performed on prospectively maintained data of patients treated between January 2017 and August 2021, using identical eligibility criteria and data collection parameters.
Eligibility Criteria Patients were considered eligible for inclusion if they were between 18 and 65 years of age and classified as American Society of Anesthesiologists physical status I-III. Eligible participants were those diagnosed with morbid obesity who had previously failed to achieve or maintain a clinically significant weight reduction despite undergoing a structured, supervised non-surgical weight management program for at least six months.
Exclusion Criteria Patients were excluded if obesity was secondary to an identifiable endocrine disorder. Additional exclusion criteria included a history of any previous bariatric surgical intervention, as well as the presence of significant cognitive impairment or major psychiatric illness. Patients demonstrating poor motivation or unwillingness to comply with long-term lifestyle modifications were also excluded. Other exclusion criteria included active substance abuse or alcoholism, pregnancy at the time of enrollment or planned pregnancy within the following 12 months, and a history of previous upper abdominal laparotomy that could potentially alter surgical anatomy or increase operative complexity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age between 18 and 65 years
- •Classified as American Society of Anesthesiologists (ASA) physical status I-III
- •Diagnosed with morbid obesity
- •Failure to achieve or maintain clinically significant weight loss after ≥6 months of structured, supervised non-surgical weight management
- •Participation in a supervised program including dietary modification, behavioral counseling, and lifestyle interventions
排除标准
- •Obesity secondary to endocrine disorders (e.g., Cushing's syndrome)
- •Previous bariatric or metabolic surgery
- •Significant cognitive impairment affecting consent or follow-up
- •Major psychiatric illness interfering with adherence or postoperative care
- •Active substance abuse or alcoholism
- •Pregnancy at enrollment or planned pregnancy within 12 months
- •Previous major upper abdominal laparotomy affecting surgical anatomy or increasing operative risk
- •Poor motivation or unwillingness to comply with long-term lifestyle modification and follow-up