Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03104023

Enrollment

100

Registered

2017-04-07

Start date

2017-01-31

Completion date

2017-08-31

Last updated

2017-06-27

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

Conditions

Vomiting, Postoperative

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREStaple line inversion

A staple line inversion will be performed with a running suture of Polypropylene 2/0

COMBINATION_PRODUCTStaple line buttressing

The gastric section will be performed with a stapler with preloaded buttress material

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* BMI \>40 * BMI\>35 with obesity-related comorbidities

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative nausea and vomits	24 hours after surgery	Postoperative nausea and vomits will be measured using the postoperative nausea and vomiting intensity scale, described by Wengritzky et al (Br J Anaesth 2010;104:158-166). In this scale, the number of vomits are quantified, the frequence of nausea and if it is constant or varying are determined, and the duration of the feeling of nausea is established.

Countries

Spain

Contacts

Primary ContactLorea Zubiaga, MD, PhD

obesidadhospitalgeneralelche@gmail.com

Backup ContactMaria Diez, MD, PhD

neuroestimulacionobesidad@gmail.com

Outcome results

None listed

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