Obesity, MorbidNCT05146011
Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity
An observational study of Obesity, Morbid, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Gatsric balloon insertion
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients, with a BMI≥50 kg/m2 undergoing Bariatric Surgery in Chelsea and Westminster Hospital
Who may be able to join
- 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)
Who cannot join
- NA
About this study
Official title: Clinical Outcomes of Single Stage Versus Two-stage Laparoscopic Roux-en-y Gastric Bypass in the Management of Super Obesity: a Propensity Score Weighted Analysis'
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.
- Conditions
- Obesity, Morbid
- Being tested
- Gatsric balloon insertion
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gatsric balloon insertionProcedure or surgery
Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| Single stage pathway | Not described Receives: Procedure: Gatsric balloon insertion | |
| Two stage pathway | Not described Receives: Procedure: Gatsric balloon insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after Bariatric Surgery
Length of hospital stay in days following Bariatric Surgery
Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups.
Measured: 90 days following gastric bypass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study startJun 2000
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matyas Fehervari, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146011
- Sponsor's protocol ID
- PCD906
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Single Stage Versus Two-stage Laparoscopic Roux-en-y Gastric Bypass in the Management of Super Obesity: a Propensity Score Weighted Analysis'
- ClinicalTrials.gov ID
- NCT05146011
- Acronym / sponsor ID
- PCD906
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2000 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single stage pathway | – | Procedure: Gatsric balloon insertion |
| Two stage pathway | – | Procedure: Gatsric balloon insertion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients, with a BMI≥50 kg/m2 undergoing Bariatric Surgery in Chelsea and Westminster Hospital
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gatsric balloon insertionInsertion of Gastric balloon prior to laparoscopic gastric bypass surgery | Procedure or surgery | Single stage pathway, Two stage pathway |
Primary outcome
Percentage of total weight loss measured in kilograms following Bariatric Surgery
Time frame: 24 months after 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.
Length of hospital stay in days following Bariatric Surgery
Time frame: 90 days following gastric bypass surgery
Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of total weight loss measured in kilograms following Bariatric Surgery (time frame: 24 months after Bariatric Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.