Postoperative ComplicationsNCT05336331
Sleeve Gastrectomy as a Standard Bariatric Procedure
An observational study of Postoperative Complications, run by Umeå University at 1 site in Sweden.
Trial summary
This study compared differences in weight loss, comorbidity resolution and complications and reoperations between a recently established sleeve gastrectomy (SG) and prior laparoscopic Rox-en-Y gastric bypass (RYGB). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- SG or a RYGB
- Type of treatment
- Surgery or procedure
- How many people
- 1,015 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 31 Dec 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Morbid obesity patients found suitable for a SG or RYGB
Who may be able to join
- Patients with either a BMI 35 or higher with comorbidity, or patients with a BMI of 40 or more without known comorbidity associated, undergoing a primary laparoscopic bariatric surgery in Sundsvall,Sweden 2010-01-01 to 2018-06-10.
Who cannot join
- All other patients undergoing a bariatric surgery during this time frame
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Laparoscopic Sleeve Gastrectomy as a Standard Procedure at a Swedish Bariatric Center
This study compared differences in weight loss, comorbidity resolution and complications and reoperations between a recently established sleeve gastrectomy (SG) and prior laparoscopic Rox-en-Y gastric bypass (RYGB).
Read the detailed description
This retrospective study with prospectively collected registry data presents results from establishment of SG as standard procedure for morbid obesity. Our first 368 patients operated with a SG were compared to 647 patients previously operated with a (RYGB. Perioperative data and results up to 2 years postoperatively regarding weight control, metabolic control as well as complications/reoperations necessary were registered.
In summary, a RYGB was associated with a longer operation time and higher rates of late complications and reoperations. Diabetes resolution was similar in both groups but patients with a RYGB had greater weight loss and significant improvement in hypertension and dyslipidemias.
- Conditions
- Postoperative Complications
- Being tested
- SG or a RYGB
- Keywords
- bariatric surgery, laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, Morbid obesity, Weight loss, Metabolic control, Metabolic syndrome, Complication risk
- Medical subject headings
- Postoperative Complications, Obesity, Morbid, Weight Loss, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG or a RYGBProcedure or surgery
operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sleeve gastrectomy (SG) | Patients operated on with a SG Receives: Procedure: SG or a RYGB | |
| laparoscopic Roux-en-Y gastric bypass (RYGB) | patients operated on with aRYGB Receives: Procedure: SG or a RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
weight and height will be combined to report various measurements of BMI in kg/m^2
Measured: after 6 weeks
Weight loss
weight and height will be combined to report various measurements of BMI in kg/m^2
Measured: after 1 year
Weight loss
weight and height will be combined to report various measurements of BMI in kg/m^2
Measured: after 2 years
Changes in Diabetes
measured as fasting plasma glucose and/or Hemoglobin A1c
Measured: after 1 year
Changes in Diabetes
measured as fasting plasma glucose and/or Hemoglobin A1c
Measured: after 2 years
Changes in Hypertension
measured as Systolic- and Diastolic Blood Pressure
Measured: after 1 year
Changes in Hypertension
measured as Systolic- and Diastolic Blood Pressure
Measured: after 2 years
Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l)
Measured: after 1 year
Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l)
Measured: after 2 year
Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L).
Measured: after 1 years
Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L).
Measured: after 2 years
Duration of surgery
Operation time in minutes
Measured: From the start of the operation until completion, in average 62 minutes
Duration of hospital stay
Duration of hospital stay in days
Measured: From time of operation until discharge, in average 1.7 days
Early complications
Complications occurred until six weeks from operation
Measured: At six weeks
Early reoperations
Reoperations occurred until six weeks from operation
Measured: At six weeks
Late complications
Complications occurred from six weeks until 2 years from operation
Measured: From six weeks until 2 years from operation
Late reoperations
Reoperations occurred from six weeks until 2 years from operation
Measured: From six weeks until 2 years from operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,015 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336331
- Sponsor's protocol ID
- YCengiz
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Laparoscopic Sleeve Gastrectomy as a Standard Procedure at a Swedish Bariatric Center
- ClinicalTrials.gov ID
- NCT05336331
- Acronym / sponsor ID
- YCengiz
- Conditions
- Postoperative Complications
- Keywords
- bariatric surgery, laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, Morbid obesity, Weight loss, Metabolic control, Metabolic syndrome, Complication risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,015 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Apr 2022 (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.
This study compared differences in weight loss, comorbidity resolution and complications and reoperations between a recently established sleeve gastrectomy (SG) and prior laparoscopic Rox-en-Y gastric bypass (RYGB).
Detailed description
This retrospective study with prospectively collected registry data presents results from establishment of SG as standard procedure for morbid obesity. Our first 368 patients operated with a SG were compared to 647 patients previously operated with a (RYGB. Perioperative data and results up to 2 years postoperatively regarding weight control, metabolic control as well as complications/reoperations necessary were registered.
In summary, a RYGB was associated with a longer operation time and higher rates of late complications and reoperations. Diabetes resolution was similar in both groups but patients with a RYGB had greater weight loss and significant improvement in hypertension and dyslipidemias.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sleeve gastrectomy (SG) | – | Procedure: SG or a RYGBPatients operated on with a SG |
| laparoscopic Roux-en-Y gastric bypass (RYGB) | – | Procedure: SG or a RYGBpatients operated on with aRYGB |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Morbid obesity patients found suitable for a SG or RYGB
Key inclusion criteria (1 listed)
- Patients with either a BMI 35 or higher with comorbidity, or patients with a BMI of 40 or more without known comorbidity associated, undergoing a primary laparoscopic bariatric surgery in Sundsvall,Sweden 2010-01-01 to 2018-06-10.
Key exclusion criteria (1 listed)
- All other patients undergoing a bariatric surgery during this time frame
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 |
|---|---|---|
| SG or a RYGBoperation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive | Procedure or surgery | laparoscopic Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastrectomy (SG) |
Primary outcome
Weight loss
Time frame: after 6 weeks
weight and height will be combined to report various measurements of BMI in kg/m^2
Weight loss
Time frame: after 1 year
weight and height will be combined to report various measurements of BMI in kg/m^2
Weight loss
Time frame: after 2 years
weight and height will be combined to report various measurements of BMI in kg/m^2
Changes in Diabetes
Time frame: after 1 year
measured as fasting plasma glucose and/or Hemoglobin A1c
Changes in Diabetes
Time frame: after 2 years
measured as fasting plasma glucose and/or Hemoglobin A1c
Changes in Hypertension
Time frame: after 1 year
measured as Systolic- and Diastolic Blood Pressure
Changes in Hypertension
Time frame: after 2 years
measured as Systolic- and Diastolic Blood Pressure
Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
Time frame: after 1 year
measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l)
Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
Time frame: after 2 year
measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l)
Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
Time frame: after 1 years
Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L).
Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
Time frame: after 2 years
Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L).
Duration of surgery
Time frame: From the start of the operation until completion, in average 62 minutes
Operation time in minutes
Duration of hospital stay
Time frame: From time of operation until discharge, in average 1.7 days
Duration of hospital stay in days
Early complications
Time frame: At six weeks
Complications occurred until six weeks from operation
Early reoperations
Time frame: At six weeks
Reoperations occurred until six weeks from operation
Late complications
Time frame: From six weeks until 2 years from operation
Complications occurred from six weeks until 2 years from operation
Late reoperations
Time frame: From six weeks until 2 years from operation
Reoperations occurred from six weeks until 2 years from operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Umeå University at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Weight loss (time frame: after 6 weeks). The study lists 17 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 20 Apr 2022.