An observational study in Bariatric Surgery Candidate, Obesity, Morbid and Leak, Anastomotic, sponsored by University of Foggia. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by University of Foggia · Observational
Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be used to reduce the leakage rate after sleeve gastrectomy.
936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.
This study's enrollment of 33 is below the median of 77 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →University of Foggia is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
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Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .
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Exclusion Criteria:
Laparoscopic sleeve gastrectomy running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.
Procedure: laparoscopic sleeve gastrectomy with suture reinforcement
Laparoscopic sleeve gastrectomy without staple line reinforcement.
Procedure: laparoscopic sleeve gastrectomy without suture reinforcement
The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access.
The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access. At this point, it is applied running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.
the importance of staple line reinforcement
reduction of the leak rate in the suture group
Time frame: 1 year
the importance of staple line reinforcement
the differences of operative time between two groups
Time frame: During Surgery
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Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Foggia