Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Vomiting, Postoperative

Treatments: Procedure: Staple line inversion; Combination Product: Staple line buttressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03104023

HGUE 2016-33

Details and patient eligibility

About

Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material

Postoperative nausea and vomits during the first 24 hours will be investigated.

Full description

Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).

Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI >40
• BMI>35 with obesity-related comorbidities

Exclusion criteria

• Patients undergoing other bariatric techniques than sleeve gastrectomy
• Laparotomic approach

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Staple line inversion

Active Comparator group

Description:

Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0.

Treatment:

Procedure: Staple line inversion

Staple line buttressing

Experimental group

Description:

The gastric section will be performed with preloaded buttress material .

Treatment:

Combination Product: Staple line buttressing