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Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sleeve gastrectomy
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Sleeve gastrectomy, banded sleeve, obesity surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Morbid obesity
  • Failure of medical treatment
  • >18yrs; <60 yrs

Exclusion Criteria:

  • Previous bariatric or GI surgery
  • Psychiatric disease
  • Pregnancy
  • Contraindication to laparoscopy

Sites / Locations

  • Tor Vergata University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic banded sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Arm Description

Group undergoing banded sleeve

Group undergoing standard sleeve

Outcomes

Primary Outcome Measures

weight loss
comparison of weight loss between the two procedures

Secondary Outcome Measures

Complications
Short and mid-term complications

Full Information

First Posted
January 9, 2020
Last Updated
January 11, 2020
Sponsor
University of Rome Tor Vergata
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1. Study Identification

Unique Protocol Identification Number
NCT04228185
Brief Title
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results
Official Title
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term. The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term. Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years. Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Sleeve gastrectomy, banded sleeve, obesity surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic banded sleeve gastrectomy
Arm Type
Experimental
Arm Description
Group undergoing banded sleeve
Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Group undergoing standard sleeve
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
Comparison of banded and not-banded sleeve gastrectomy
Primary Outcome Measure Information:
Title
weight loss
Description
comparison of weight loss between the two procedures
Time Frame
from surgery to 4 years follow up
Secondary Outcome Measure Information:
Title
Complications
Description
Short and mid-term complications
Time Frame
from surgery to 4 years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Morbid obesity Failure of medical treatment >18yrs; <60 yrs Exclusion Criteria: Previous bariatric or GI surgery Psychiatric disease Pregnancy Contraindication to laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano D'Ugo, MD PhD
Organizational Affiliation
Tor Vergata University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tor Vergata University Hospital
City
Roma
ZIP/Postal Code
00133
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32566276
Citation
Gentileschi P, Bianciardi E, Siragusa L, Tognoni V, Benavoli D, D'Ugo S. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. J Obes. 2020 May 28;2020:9792518. doi: 10.1155/2020/9792518. eCollection 2020.
Results Reference
derived

Learn more about this trial

Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

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