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

NCT02479971 | Completed Phase 3 DMC

• 1 other identifier: HGUE 2015-5
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

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

  24 hours after surgery

Secondary Outcomes (1)

• C reactive protein

  24 hours after surgery

Study Arms (2)

Normal saline irrigation

ACTIVE COMPARATOR

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

Drug: Normal saline irrigation

Clindamycin-gentamicin irrigation

EXPERIMENTAL

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

Drug: Clindamycin-gentamicin irrigation

Interventions

Clindamycin-gentamicin irrigation DRUG

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

Also known as: Clindamycin-gentamicin solution

Clindamycin-gentamicin irrigation

Normal saline irrigation DRUG

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

Also known as: Saline irrigation

Normal saline irrigation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio Arroyo, MD, PhD

  Hospital general Elche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jaime Ruiz-Tovar, MD, PhD

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06