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

NCT ID: NCT04228185

Last Updated: 2020-01-14

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic banded sleeve gastrectomy

Group undergoing banded sleeve

Group Type EXPERIMENTAL

sleeve gastrectomy

Intervention Type PROCEDURE

Comparison of banded and not-banded sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Group undergoing standard sleeve

Group Type ACTIVE_COMPARATOR

sleeve gastrectomy

Intervention Type PROCEDURE

Comparison of banded and not-banded sleeve gastrectomy

Interventions

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sleeve gastrectomy

Comparison of banded and not-banded sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous bariatric or GI surgery
* Psychiatric disease
* Pregnancy
* Contraindication to laparoscopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Stefano D'Ugo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefano D'Ugo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Tor Vergata University Hospital

Locations

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Tor Vergata University Hospital

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 32566276 (View on PubMed)

Other Identifiers

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Banded_Sleeve

Identifier Type: -

Identifier Source: org_study_id

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