Sleeve Gastrectomy: Outcome, Morbidity and Mortality. A Multicentric Retrospective Trial

NCT04643262 | Enrolling By Invitation

• 1 other identifier: 18112010
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Morbid Obesity

Keywords

Bariatric surgery; morbidity and mortality

Outcome Measures

Primary Outcomes (5)

• Intraoperative complications

  splenectomy, bleeding, positive leak test if performed

  time 0

• Perioperative complications

  Mortality

  up to 4 weeks from surgery

• Perioperative complications

  Morbidity:( leak, bleeding, occlusion, pneumonia, vascular complications, portal pulmonary-splenic embolism) \< 30 days

  up to 4 weeks from surgery

• Postoperative complications

  Mortality

  up to 6 months

• Postoperative complications

  Morbidity: (leak, embolism, Incisional trocar hernia) \>30 days

  up to 6 months

Study Arms (3)

Intraoperative morbidity and mortality

Intraoperative complications (i.e. splenectomy, bleeding, positive leak test if performed) and type treatment are collected and recorded.

Procedure: Sleeve Gastrectomy

peri-operative morbidity and mortality (<30 days)

Perioperative complications (\<30 days) considered are mortality, morbidity (i.e. leak, bleeding, occlusion, pneumonia, vascular complications, portal pulmonary-splenic embolism) and type treatment.

Procedure: Sleeve Gastrectomy

Post-operative morbidity and mortality (>30 days)

Postoperative complications (\>30 days) considered are morbidity, mortality (i.e. leak, embolism, Incisional trocar hernia, other) and type treatment

Procedure: Sleeve Gastrectomy

Interventions

Sleeve Gastrectomy PROCEDURE

Once the left crus is reached, an optimal exposure of the hiatus is mandatory to find incidental hiatal hernias and a complete dissection of the left crus performed to prevent retained fundus. The greater omentum was opened close to the stomach wall in some part in between the fundus and the antrum to have greater curvature completely detached from the stomach; this dissection starts at 2 cm or \_\_\_\_\_proximal to the pylorus and continued along the greater curvature to the left crus. Posterior adhesions if present, were carefully divided. The left gastrophrenic ligament was divided to expose the angle of His to identify the complete hiatus and fundus. A bougie was positioned before starting resection of the stomach. We use a 36French bougie or --------- we have chosen cartridges Black at the antrum level and finished with a purple cartridge. We always checked the posterior wall before firing.

Intraoperative morbidity and mortality; Post-operative morbidity and mortality (>30 days); peri-operative morbidity and mortality (<30 days)

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a retrospective multicenter trial conduct from January 2015 to December 2020 in 20 centers. All patients underwent Sleeve Gastrectomy. 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, Responsible for the Bariatric and Metabolic Surgery unit

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 25, 2020
• Study Start: January 1, 2015
• Primary Completion: January 1, 2015
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 21, 2021

Record last verified: 2021-07