Sleeve Gastrectomy: Outcome, Morbidity and Mortality. A Multicentric Retrospective Trial. PSICHE TRIAL (Postoperative Sleevegastrectomy Italian or (International) Group Complications Highlights Experience)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000
- 主要终点
- Intraoperative complications
研究概览
简要总结
Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is a safe and effective technique in terms of excess weight loss and it is, moreover, a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behavior, glycemic control and intestinal functions.Regarding a technical point of view, LSG might be considered a time saving procedure for the absence of intestinal anastomosis. The most frequent and sometimes dangerous complications are leaking, hemorrhage, splenic injury, stenosis and Gastro-Esophageal Reflux Disease (GERD). Despite its established efficacy and safety, dispute still exists on the optimal conduction of LSG operative technique: bougie size, distance of resection margin from the pylorus, the shape of section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing are among the most controversial issues .
Thus, the primary aim of the present retrospective multicentric study is to evaluate intra and peri-operatory (< 30 days) and post-operative (> 30 days) morbidity and mortality rates of patients undergone LSG, and the correlation of the latter rates with different surgical measures. Secondary aim is to evaluate the strategy for the treatment of the complication, and if there is a correlation between morbidity/mortality and volume of the Bariatric Center
详细描述
This study is a retrospective multicenter trial conduct from January 2015 to December 2020 in 10 centers. All the procedures were performed by the (---- number of surgeons). Morbid obesity was preoperatively diagnosed according to the International Federation for Surgery of Obesity (IFSO) guidelines. Patients were collected in a electronic database and categorized according to the following parameters:
- Distance of resection margin from the pylorus (>5 cm / <5 cm)
- Bougie size (>34 French, <34 French)
- Distance of resection margin from the gastroesophageal junction (>...cm/<...cm)
- Staple line reinforcement (Yes/No - If yes, the reinforcement technique will be reported)
- Intraoperative leak testing (Yes/No - If yes, the test used will be reported)
- Number and size of trocar used and access closure technique (Yes/No - If yes, the technique will be reported) The study protocol was approved by the regional Ethics Committee. 2.2 Inclusion criteria Inclusion criteria were morbid obesity defined as BMI 40 kg/m2 or BMI>35 with comorbidity and age between 25-60 years old. Obesity-related comorbidities included Type 2 Mellitus Diabetes (T2MD), hypertension, hyperlipidemia, bronchial asthma, osteoarthritis and degenerative joint disease.
2.3 Exclusion Criteria Patients with endocrine disorders causing obesity (as hypothyroidism and Cushing disease), pregnancy or lactation, psychiatric illness, or recent diagnosis of malignancy, inflammatory bowel disease, Barrett ́s esophagus, and GERD with esophagitis scored as or greater than grade B, a large hiatal hernia (>3 cm) were excluded from the study.
2.4 Study Outcomes The primary aims of the present retrospective multicentric study is to evaluate intra and peri and post operatory morbidity and mortality rates (< 30 and >30 days) of patients undergone Laparoscopic Sleeve Gastrectomy, and the correlation of the latter rates with different surgical measures. Secondary aims is to evaluate the strategy for the treatment of the complication, and if there is a correlation between morbidity/mortality and the volume of the Bariatric Center.
2.6 Blinding Process Physicians and staff who will collect the data and those who will evaluate the endpoints will all be unaware of the patients allocation. Patients will be collected in an electronic database with consecutive numbers without the possibility of identifying the center of origin until the final evaluation of the study endpoints. As the blinding process for the operating surgeons is not feasible, they are not involved in data collection and evaluation of results.
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 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Morbid obesity defined as Body Mass Index 40 kg/m2
- •Body Mass Index >35 with comorbidity (Type 2 Mellitus Diabetes (T2MD), hypertension, hyperlipidemia, bronchial asthma, osteoarthritis))
- •Age between 25-68 years old.
排除标准
- •Patients with endocrine disorders causing obesity (as hypothyroidism and Cushing disease)
- •Pregnancy or lactation
- •Psychiatric illness
- •Recent diagnosis of malignancy
- •Inflammatory bowel disease
- •Barrett ́s esophagus
结局指标
主要结局
Intraoperative complications
时间窗: time 0
splenectomy, bleeding, positive leak test if performed
Perioperative complications
时间窗: up to 4 weeks from surgery
Morbidity:( leak, bleeding, occlusion, pneumonia, vascular complications, portal pulmonary-splenic embolism) \< 30 days
Postoperative complications
时间窗: up to 6 months
Morbidity: (leak, embolism, Incisional trocar hernia) \>30 days
次要结局
未报告次要终点
研究者
Francesco Pizza
MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit
Azienda Sanitaria Locale Napoli 2 Nord