NCT01459471

Brief Summary

The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

5 months

First QC Date

October 4, 2011

Last Update Submit

October 21, 2011

Conditions

Complication of Surgical ProcedureLeak; Blood

Outcome Measures

Primary Outcomes (1)

  • safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.

    a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed

    six months

Study Arms (1)

bleeding, leak, operative time

EXPERIMENTAL
Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Staple line reinforcement during sleeve gastrectomy

Also known as: bariatric surgical procedure, gastric resection, steaple line reinforcement
bleeding, leak, operative time

Eligibility Criteria

Age28 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Morbidly obese patients waiting for sleeve gastrectomy

You may not qualify if:

  • BMI\<35 Kg/m2,
  • Important comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bariatric SurgeryGastrectomy

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Paolo Gentileschi, MD

    University of Tor Vergata, Rome, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 25, 2011

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 25, 2011

Record last verified: 2011-10