Suture Reinforcement to Reduce the Leak… | Clinical Trial

Key information

Conditions

Bariatric Surgery Candidate Anastomotic Leak Bleeding Body Weight Hemorrhage Leak, Anastomotic Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Foggia

Foggia, 71122, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic sleeve gastrectomy without suture reinforcement

Procedure

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.

laparoscopic sleeve gastrectomy with suture reinforcement

Procedure

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.

Primary outcomes

the importance of staple line reinforcement

Time frame: 1 year

reduction of the leak rate in the suture group
the importance of staple line reinforcement

Time frame: During Surgery

the differences of operative time between two groups

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Aug 14, 2023
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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