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OpenTrials
Completed

NCT Number: NCT04354532

Laparoscopic Banded Sleeve Gastrectomy

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michela Campanelli

Rome, RM, 00133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe Obesity with BMI > 35 kg/m2

Exclusion criteria

  • Alcoholism
  • Drug addiction
  • Psychiatric Disease

Treatment and study plan

Laparoscopic Banded Sleeve Gastrectomy

Procedure

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

Primary outcomes

  1. % Excess Weight Loss

    Time frame: 4 years

    Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up

Secondary outcomes

  1. Post-operative complications

    Time frame: 4 years

    Complications occurred after laparoscopic banded sleeve gastrectomy during the follow-up

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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