Plain English Summary
Background and study aims
Weight loss surgery, also called bariatric or metabolic surgery, is sometimes used as a treatment for people who are very obese. It can lead to significant weight loss and help improve many obesity-related conditions, such as type 2 diabetes or high blood pressure.
Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most popular bariatric procedures currently used. With that being said, SG and RYGB both have limitations of their own. gastroesophageal reflux disease (GERD), diabetes relapse, and weight regain are the issues that may be faced following SG. While RYGB might be able to solve the issues of GERD and diabetes relapse related to SG’s, these procedures have an equal weight loss effect. Furthermore, the RYGB procedure creates a risk in that gastric cancer screening is no longer possible. This is worrying especially in countries with high gastric cancer prevalence.
Sleeve gastrectomy with transit bipartition (SG-TB) was introduced in 2012 with the notion that this procedure might be able to solve SG’s issues. Currently studies on SG-TB are lacking, especially on the randomized controlled study comparing SG-TB and standard SG procedure. Therefore, this study is aimed to provide an answer for whether SG-TB provides additional benefits against the standard SG.
Who can participate?
Patients aged 18 - 65 years with a BMI of 27 kg/m² or above.
What does the study involve?
Participants will either undergo SG-TB or standard SG surgical procedure over the study period. Participants data on their weight and diabetes conditions as well as prevalence of GERD symptoms and incidence of surgical complications preoperatively and postoperatively will be collected at the start of the study and every 6 months for the 5 years following.
What are the possible benefits and risks of participating?
SG-TB patients might receive longer and superior weight loss and anti-diabetic outcomes than the SG patients. Also fewer SG-TB patients might have GERD symptoms than SG patients.
As SG-TB procedure is a relatively new procedure, there are complications that can occur that have never been previously reported, such as marginal ulcer and severe malnutrition. It has been reported previously that SG-TB might have complications such as incisional or internal hernia and mild malnutrition. On the other hand, standard SG might have increased in leakage and postoperative GERD risks due to the high pressured “sleeve”.
Where is the study run from?
Affiliated Hospital of Xuzhou Medical University (China)
When is the study starting and how long is it expected to run for?
August 2019 to December 2026
Who is funding the study?
Affiliated Hospital of Xuzhou Medical University (China)
Who is the main contact?
Dr Jason Widjaja
drjwbs@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jason Widjaja
ORCID ID
http://orcid.org/0000-0003-0103-6147
Contact details
No.99 Huaihai West Road
Affiliated Hospital of Xuzhou Medical University
Xuzhou
221006
China
+86 15094357019
drjwbs@yahoo.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
XYFY2020-JS003-01
Study information
Scientific title
Weight loss and diabetes remission outcomes on SG-TB versus SG: a randomized controlled trial
Acronym
Study hypothesis
1. Transit bipartition is superior or equal to sleeve gastrectomy in inducing weight loss.
2. Transit bipartition is superior to sleeve gastrectomy in inducing diabetes remission.
Ethics approval
Approved 08/06/2020, Ethical Committee of The Affiliated Hospital of Xuzhou Medical University (Department of General Surgery, the Affiliated Hospital of Xuzhou Medical University, Huaihai West Road No. 99, Xuzhou Jiangsu 221002, P. R. China; no telephone number provided; zhuxccf@163.com), ref: XYFY2020-JS003-01
Study design
Single-centered interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity with or without type-2 diabetes mellitus
Intervention
The study implements a randomized controlled trial (RCT) design (1:1 ratio) involving at least 100 patients undergoing bariatric surgery in total with ≥50 in the sleeve gastrectomy with transit bipartition (SG-TB) group and ≥50 in the standard sleeve gastrectomy group. The study surgery, data collection, analysis, and evaluation that applies to all groups will be performed by the same individuals. And detailed intervention in intervention arms varies from patient to patient due to the personalized approach. The analysis and reporting of the trial will be in accordance with the CONSORT guidelines.
The overall goal of this particular study is to find out the benefits of SG-TB procedure against the standard SG. In overall:
1. Is SG-TB superior to standard SG in terms of the short-term (1 year) and long-term (>5 years) weight loss outcome?
2. Is SG-TB superior to standard SG in terms of the short-term (1 year) and long-term (>5 years) diabetes remission outcome?
3. The prevalence of gastroesophageal reflux disease (GERD) following both procedures.
4. The early and late complications of SG-TB.
To compare the weight loss efficacy between SG-TB and standard SG, variables that are included are as such: weight (kg), height (m), BMI (calculated using patient’s weight and height). In terms of the anti-diabetic outcomes: fasting blood glucose (mmol/L), glycosylated hemoglobin (% HbA1C), fasting insulin and C-peptide; Complete remission is defined as HbA1C <6% without anti-diabetic medications and partial remission as 6-6.49%. These variables will be monitored every 6 months since surgery (at 0, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months). In terms of GERD, preoperatively patients will undergo endoscopy for diagnosis as well as history taking of using PPI to solve GERD symptoms; postoperatively all patients will be monitor on the use of PPI as well as performing endoscopy every 1 year since surgery. Early complications are defined as complications that occur within 30 days after the surgery, and late complications as complications occurring in the period following 30 days after surgery.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
At surgery, 1-year and 5-year follow-up
1. Weight (kg)
2. BMI (weight, kg divided by the square of height, m)
3. Percentage of Excess BMI Loss, %EBMIL ([(preoperative BMI – postoperative BMI) / (Preoperative BMI – 25)] x 100%”)
Secondary outcome measures
1. Diabetes Remission measured at surgery, 1-year and 5-year follow-up using:
1.1. Fasting blood glucose, HbA1C (blood test)
1.2. Anti-diabetic drug usage (patient records)
Overall trial start date
01/08/2019
Overall trial end date
31/12/2026
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-65 years old
2. BMI ≥27.5 kg/m²
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned a total of 100 patients (Each 50)
Participant exclusion criteria
1. Type-2 diabetes mellitus of longer than 15 years
2. Previous bariatric surgery
3. Patients debilitated with neurological, cardiovascular and/or malignancies before the procedure
4. Patients refusal to sign the consent form
Recruitment start date
01/01/2020
Recruitment end date
31/12/2021
Locations
Countries of recruitment
China
Trial participating centre
The Affiliated Hospital of Xuzhou Medical University
No.99 Huaihai West Road
Department of General Surgery
Affiliated Hospital of Xuzhou Medical University
Xuzhou
221006
China
Sponsor information
Organisation
Affiliated Hospital of Xuzhou Medical College
Sponsor details
Huaihai West Road no. 99 (徐州市泉山区淮海西路99号)
Xuzhou
221006
China
+86 18052268152
zhuxccf@163.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Xuzhou Medical University
Alternative name(s)
XZMU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
China
Results and Publications
Publication and dissemination plan
We plan to publish 2 papers, 1-year and 5-year outcomes of the study. The 1-year outcome is expected to be published in early 2022. The 5-year outcome is expected to be published in early 2027.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/01/2022
Participant level data
Other
Basic results (scientific)
Publication list