Clinical trial NCT04354532: Laparoscopic Banded Sleeve Gastrectomy
Official title: Laparoscopic Banded Sleeve Gastrectomy: Single-Centre Experience With A 4-Year Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Surgery
Keywords: Sleeve gastrectomy
Banded sleeve gastrectomy
Laparoscopy
Bariatric Surgery
Obesity
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Severe Obesity with BMI \> 35 kg/m2

Exclusion Criteria:

* Alcoholism
* Drug addiction
* Psychiatric Disease

Primary outcomes:
measure: % Excess Weight Loss
timeFrame: 4 years
Secondary outcomes:
measure: Post-operative complications
timeFrame: 4 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Michela Campanelli
state: RM
Study officials:
affiliation: University Hospital of Tor Vergata, Rome, Italy
name: paolo gentileschi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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