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

NCT04643262 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2021-07-21

No results posted yet for this study

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

Interventions

PROCEDURE

Sleeve Gastrectomy

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.

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2015-01-01
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643262 on ClinicalTrials.gov