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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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8 June 2020 |
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Main ID: |
ISRCTN56106651 |
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Date of registration:
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06/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Laparoscopic band-separated mini-gastric bypass
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Scientific title:
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Comparison of laparoscopic band-separated mini-gastric bypass and linear cutter stapler-separated mini-gastric bypass: a randomized controlled trial |
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Date of first enrolment:
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20/07/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN56106651 |
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Study type:
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Interventional |
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Study design:
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Interventional prospective randomized controlled trial single-centre study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Kazakhstan
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Oral
Ospanov |
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Address:
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Syganak str.,5/1, kv.48
010016
Astana
Kazakhstan |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Obese patients with BMI = 60 kg/m2.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Morbid obesity
Nutritional, Metabolic, Endocrine
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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Postoperative morbidity
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Source(s) of Monetary Support
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The Society of Bariatric and Metabolic Surgeons of Kazakhstan
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee of Astana Medical University, 17/07/2015, ref: No. 7
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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22/01/2017 |
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URL:
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