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Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Staple-line Suture Reinforcement: Could it Help Contain the Leak?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05987787
Enrollment
33
Registered
2023-08-14
Start date
2022-01-01
Completion date
2023-07-01
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Bleeding, Leak, Anastomotic, Obesity, Morbid

Brief summary

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.

Interventions

PROCEDURElaparoscopic 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.

PROCEDURElaparoscopic sleeve gastrectomy with 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. 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.

Sponsors

University of Foggia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* BMI\>40 kg/m2 * BMI\>35 kg/m2with at least one associated major comorbidity

Exclusion criteria

* secondary obesity due to endocrine and psychological disorders * patients under antiaggregant and anticoagulant therapy * re-do surgery.

Design outcomes

Primary

MeasureTime frameDescription
the importance of staple line reinforcement1 yearreduction of the leak rate in the suture group

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026