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CompletedNCT05146011Updated Dec 6, 2021

Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity

An observational study in Obesity, Morbid, sponsored by Imperial College London. Completed. Per ClinicalTrials.gov, last updated 2021-12-06.

Sponsored by Imperial College London · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
155
Sex
All
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Study summary

Laparoscopic Roux-en-Y gastric bypass (LRYGB) in super obese patients (BMI≥50kg/m2) is a challenging operation. Weight reduction with intragastric balloon (IGB) prior to LRYGB may improve operative outcomes and improves weight loss. We assessed 155 patients, with a BMI≥50 kg/m2 who underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) in our institution. Two stage procedure was adopted for high-risk individuals.

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Conditions studied

  • Obesity, Morbid
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 155 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients, with a BMI≥50 kg/m2 undergoing Bariatric Surgery in Chelsea and Westminster Hospital

Inclusion criteria

  • patients, with a BMI≥50 kg/m2, underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group)

Exclusion criteria

Exclusion Criteria:

  • NA
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
155 participants (actual)
Patient registry
No

Groups and cohorts

  • Single stage pathway

    Procedure: Gatsric balloon insertion

  • Two stage pathway

    Procedure: Gatsric balloon insertion

Interventions

  • ProcedureGatsric balloon insertion

    Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

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What researchers measure

Primary outcomes

  1. Percentage of total weight loss measured in kilograms following Bariatric Surgery

    Percentage total weight loss is the proportion of weight lost in kilograms since the intervention of the weight before the intervention. This will be calculated by using the following formula. Initial weight is considered the weight on the day of surgery and Postop weight considered as the weight 24 months following Bariatric Surgery (intervention). Percent of total weight loss (%TWL)=((Initial Weight)-(Postop Weight)): Initial Weight x 100 Weight is expressed in kilograms.

    Time frame: 24 months after Bariatric Surgery

  2. Length of hospital stay in days following Bariatric Surgery

    Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups.

    Time frame: 90 days following gastric bypass surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05146011
Lead sponsor
Imperial College London
Responsible party
Matyas Fehervari (Honorary Clinical Research Fellow, Imperial College London) — Principal investigator
First posted
Dec 6, 2021
Start date
Jun 2000
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Dec 6, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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