Plain English Summary
Background and study aims:
A gastric bypass is a type of weight loss surgery. It involves making the stomach smaller using special surgical staplers. These creates a small pouch which is then connected to a section of the small intestine, therefore bypassing the rest of the stomach and bowel. This results in a person not being able to eat as much food as before and they also absorb fewer calories from the food that they do eat. Modifications have included using a silicone band to restrict the size of the stomach rather than using staplers. This has many advantages, including being able to access the bypassed stomach to treat ulcers, bleeding episodes and cancer; access to the duodenum (first part of the small intestine) and bile ducts; tailored weight loss; reversal of deficiencies in vitamins and nutrients; being able to reverse the entire procedure; reduced risk of gastro-jejunostomy leaks, due to reduced pressure on the anastomosis; and prevention of acute gastric dilatation (abnormal enlargement of the stomach). However, potential disadvantages exist, including erosion of bands in the stomach and small intestine. Adjustable gastric bands with low pressure reduce the probability of band erosion and mini-gastric bypass has been shown to be effective. This study compares loss of weight, changes in other health conditions that the patient may have (co-morbidities, such as diabetes), quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of a new laparoscopic band-separated mini- gastric bypass (LBSMGB) procedure compared with the standard stapler (linear cutter) - separated mini-gastric bypass (LSSMGB).
Who can participate?
Obese adult patients with a BMI of between 35 kg/m2 and 60 kg/m2.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo the laparoscopic band-separated mini-gastric bypass procedure. Those in the second group undergo the linear cutter stapler-separated mini-gastric bypass procedure. All patients are then followed up one month after surgery and again after 3, 6 and, finally, 12 months after surgery where weight loss, changes in co-morbidities and quality of life are assessed.
What are the possible benefits and risks of participating?
Participants who undergo receive LSSMGB may be at risk of gastric (stomach) and jejunal (small intestine) leaks. Participants who receive LBSMGB may be at risk of erosion of bands in the stomach and jejunum.
Where is the study run from?
National Scientific Center for Oncology and Transplantation (Kazakhstan)
When is the study starting and how long is it expected to run for?
July 2015 to January 2017
Who is funding the study?
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Who is the main contact?
Professor Oral Ospanov
Study website
Contact information
Type
Scientific
Contact name
Prof Oral Ospanov
ORCID ID
http://orcid.org/0000-0002-1840-114X
Contact details
Syganak str.,5/1
kv.48
Astana
010016
Kazakhstan
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of laparoscopic band-separated mini-gastric bypass and linear cutter stapler-separated mini-gastric bypass: a randomized controlled trial
Acronym
LBSMGB-RCT
Study hypothesis
The aim was to compare the reduction of body weight, changes in co-morbidities, quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of laparoscopic band-separated mini- gastric bypass with stapler (linear cutter) - separated mini-gastric bypass.
Ethics approval(s)
Ethics Committee of Astana Medical University, 17/07/2015, ref: No. 7
Study design
Interventional prospective randomized controlled trial single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Morbid obesity
Intervention
Participants are randomly allocated have one of two possible surgeries:
1. Laparoscopic band-separated mini-gastric bypass: An adjustable low pressure gastric band was introduced in the abdomen and retracted through the retrogastric tunnel. The front wall of the stomach below the band was displaced in the upward direction through the ring band, increasing the size of the anterior portion of the stomach pouch so that a gastro-entero-anastomosis could be created at this point. Gastro-gastric sutures were placed to create a gastro-gastric plication around the band and hold it in position. The band tubing was exteriorized and connected to a special port, which was secured to the abdominal wall fascia. A jejunal loop was created about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch by hand using Vicryl 2/0 sutures.
2. Linear cutter stapler-separated mini-gastric bypass: standard surgery
Intervention type
Procedure/Surgery
Primary outcome measure
1. Weight loss, measured by body weight in kg (BMI – body mass index kg/m 2) and waist circumference before and after surgery and also the percentage of excess weight loss (%EWL) (at 6 months and then 12 months after surgery)
2. Changes in co-morbidities by evaluation of symptoms: diabetes improved or resolved in % of patients, hyperlipidemia improved in %, hypertension improved or resolved in %, and obstructive sleep apnea improved or resolved in % of patients
3. Quality of life, measured by the quality of life questionnaire the Moorehead-Ardelt Quality of Life Questionnaire II
Follow-up for all treatment arms: 1, 3, 6, 12 months after the surgery
Secondary outcome measures
Postoperative morbidity
Overall study start date
17/07/2015
Overall study end date
22/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Obese patients:
1. aged between 18 and 60
2. with American Society of Anesthesiologists (ASA) physical status of I or II
3. BMI ≥ 35
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
A total of 60 patients allocated in two groups each consisted of 30 patients.
Total final enrolment
80
Participant exclusion criteria
Obese patients with BMI ≥ 60 kg/m2.
Recruitment start date
20/07/2015
Recruitment end date
28/10/2016
Locations
Countries of recruitment
Kazakhstan
Study participating centre
National Scientific Center for Oncology and Transplantation
Syganak, 5/1, kv.48
Astana
010016
Kazakhstan
Sponsor information
Organisation
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Sponsor details
Syganak str.,5/1
kv.48
Astana
010016
Kazakhstan
Sponsor type
Other
Website
ROR
Funders
Funder type
Other
Funder name
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Publication ( in Trials) study protocol (March 2016)
2. Publication (in Obesity Surgery Journal) results of study (January 2017)
Intention to publish date
31/03/2016
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2019 | 28/05/2020 | Yes | No |