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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02479971

Enrollment

Registered

2015-06-24

Start date

2014-01-31

Completion date

2015-06-30

Last updated

2015-06-24

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

Conditions

Pain

Brief summary

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.

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.

Interventions

DRUGClindamycin-gentamicin irrigation

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

DRUGNormal saline irrigation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

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