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Laparoscopic Banded Sleeve Gastrectomy

Laparoscopic Banded Sleeve Gastrectomy: Single-Centre Experience With A 4-Year Follow-Up

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04354532
Enrollment
209
Registered
2020-04-21
Start date
2014-02-01
Completion date
2020-02-01
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid, Surgery

Keywords

Sleeve gastrectomy, Banded sleeve gastrectomy, Laparoscopy, Bariatric Surgery, Obesity

Brief summary

Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The Investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.

Detailed description

Introduction. Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period. Methods. The investigators performed a retrospective review of data from a prospectively collected database. All patients submitted to primary LBSG were examined. Patients were submitted to LBSG between February 2014 and January 2020. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Interventions

PROCEDURELaparoscopic Banded Sleeve Gastrectomy

The investigators performed Laparoscopic Sleeve Gastrectomy adding a MiniMizer Ring (Bariatric Solutions), a radiopaque silicone ring with four closing positions. The ring has a blue colour and for this reason it can easily be found back in revision surgery. The pulling lid is left in place with all closing positions in order to be adjusted postoperatively without having to place a new ring. The ring is slightly elastic and the fixation loops provide an anchorpoint to fix the ring in place which prevents it from slipping

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Severe Obesity with BMI \> 35 kg/m2

Exclusion criteria

* Alcoholism * Drug addiction * Psychiatric Disease

Design outcomes

Primary

MeasureTime frameDescription
% Excess Weight Loss4 yearsWeight loss after laparoscopic banded sleeve gastrectomy during the follow-up

Secondary

MeasureTime frameDescription
Post-operative complications4 yearsComplications occurred after laparoscopic banded sleeve gastrectomy during the follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026