Effect of Peritoneal Lavage With Clindamycin-gentamicin on Laparoscopic Sleeve Gastrectomy

June 22, 2015 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy

A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomized study will be performedin patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
  • Patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure.

Exclusion Criteria:

  • Gastroesophageal reflux
  • Preoperative diagnosis of chronic renal failure
  • Uncontrolled psychiatric disorders
  • Active infections
  • Malignancies
  • Any other concomitant pathology considered as a contraindication for bariatric surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
Drug: Normal saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
Other Names:
  • Saline irrigation
Experimental: Clindamycin-gentamicin irrigation
An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed.
Drug: Clindamycin-gentamicin irrigation
An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.
Other Names:
  • Clindamycin-gentamicin solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 24 hours after surgery
Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C reactive protein
Time Frame: 24 hours after surgery
C reactive protein will be evaluated at a blood analoytics obtained 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Study Director: Antonio Arroyo, MD, PhD, Hospital General Elche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGUE 2015-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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