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Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

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ClinicalTrials.gov Identifier: NCT03104023
Recruitment Status : Unknown
Verified March 2017 by Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche.
Recruitment status was:  Recruiting
First Posted : April 7, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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.


Condition or disease Intervention/treatment Phase
Vomiting, Postoperative Procedure: Staple line inversion Combination Product: Staple line buttressing Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Staple line inversion
Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0.
Procedure: Staple line inversion
A staple line inversion will be performed with a running suture of Polypropylene 2/0

Experimental: Staple line buttressing
The gastric section will be performed with preloaded buttress material .
Combination Product: Staple line buttressing
The gastric section will be performed with a stapler with preloaded buttress material




Primary Outcome Measures :
  1. Postoperative nausea and vomits [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104023


Contacts
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Contact: Lorea Zubiaga, MD, PhD obesidadhospitalgeneralelche@gmail.com
Contact: Maria Diez, MD, PhD neuroestimulacionobesidad@gmail.com

Locations
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Spain
Hospital general Universitario de Elche Recruiting
Elche, Alicante, Spain, 03202
Contact: Jaime Ruiz-Tovar, MD, PhD    0034-630534808    jruiztovar@gmail.com   
Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Principal Investigator: Jaime Ruiz-Tovar Hospital general Elche

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Head of Bariatric Surgery Unit. Hospital general Elche, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03104023     History of Changes
Other Study ID Numbers: HGUE 2016-33
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea