Effect of Peritoneal Lavage With Clindamycin-gentamicin o... | NCT02479971

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

NCT02479971

Sponsor

Hospital General Universitario Elche

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Pain

Interventions

Clindamycin-gentamicin irrigation
Normal saline irrigation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jun 17, 2015

First Submission Date that Met QC Criteria

Jun 22, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Ruiz-Tovar, MD, PhD, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario ElchePrincipal Investigator

Lead Sponsor

Hospital General Universitario ElcheOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clindamycin-gentamicin irrigation	Drug	An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.	Clindamycin-gentamicin irrigation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio Arroyo, MD, PhD	Hospital general Elche	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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