Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedJanuary 14, 2020
January 1, 2020
1 year
January 9, 2020
January 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight loss
comparison of weight loss between the two procedures
from surgery to 4 years follow up
Secondary Outcomes (1)
Complications
from surgery to 4 years follow up
Study Arms (2)
Laparoscopic banded sleeve gastrectomy
EXPERIMENTALGroup undergoing banded sleeve
Laparoscopic sleeve gastrectomy
ACTIVE COMPARATORGroup undergoing standard sleeve
Interventions
Comparison of banded and not-banded sleeve gastrectomy
Eligibility Criteria
You may qualify if:
- Morbid obesity
- Failure of medical treatment
- \>18yrs; \<60 yrs
You may not qualify if:
- Previous bariatric or GI surgery
- Psychiatric disease
- Pregnancy
- Contraindication to laparoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tor Vergata University Hospital
Roma, 00133, Italy
Related Publications (1)
Gentileschi P, Bianciardi E, Siragusa L, Tognoni V, Benavoli D, D'Ugo S. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. J Obes. 2020 May 28;2020:9792518. doi: 10.1155/2020/9792518. eCollection 2020.
PMID: 32566276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano D'Ugo, MD PhD
Tor Vergata University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 14, 2020
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2019
Last Updated
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share