MedDataX Logo

Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

NCT ID: NCT01459471

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complication of Surgical Procedure Leak; Blood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bleeding, leak, operative time

Group Type EXPERIMENTAL

Bariatric surgery

Intervention Type PROCEDURE

Staple line reinforcement during sleeve gastrectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bariatric surgery

Staple line reinforcement during sleeve gastrectomy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

bariatric surgical procedure gastric resection steaple line reinforcement

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria

* BMI\<35 Kg/m2,
* Important comorbidities
Minimum Eligible Age

28 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paolo Gentileschi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paolo Gentileschi, MD

Role: STUDY_DIRECTOR

University of Tor Vergata, Rome, Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SEND-11-0905

Identifier Type: -

Identifier Source: org_study_id