Effect of Peritoneal Lavage With Clindamycin-gentamicin on 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Clindamycin-gentamicin irrigation

Drug

An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.

Other names: Clindamycin-gentamicin solution

Normal saline irrigation

Drug

An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.

Other names: Saline irrigation

Primary outcomes

Postoperative pain

Time frame: 24 hours after surgery

Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery

Secondary outcomes

C reactive protein

Time frame: 24 hours after surgery

C reactive protein will be evaluated at a blood analoytics obtained 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 24, 2015
Registry last updated: Jun 24, 2015

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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Completed