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

Obesity, Morbid Clinical Trial

Official title:

Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228185
• Other study ID #: Banded_Sleeve
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: January 2020
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2019
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Morbid obesity

• Failure of medical treatment

• >18yrs; <60 yrs

Exclusion Criteria:

• Previous bariatric or GI surgery

• Psychiatric disease

• Pregnancy

• Contraindication to laparoscopy

Related Conditions & MeSH terms

• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• sleeve gastrectomy
Comparison of banded and not-banded sleeve gastrectomy

Locations

Country	Name	City	State
Italy	Tor Vergata University Hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	comparison of weight loss between the two procedures	from surgery to 4 years follow up
Secondary	Complications	Short and mid-term complications	from surgery to 4 years follow up