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

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clinicaltrials.gov/study/NCT04228185
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT042281850
Trial Recruitment Size
500
Trial Sponsor
University of Rome Tor Vergata
University of Rome Tor Vergata
0
Clinical Trial Start Date
2014
0
Primary Completion Date
2015
0
Study Completion Date
2019
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Procedure0
Intervention Name
sleeve gastrectomy0
Interventional Trial Phase
Not Applicable0
Official Name
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study0
Last Updated
January 14, 2020
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study 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.

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