Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356213
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
2006-07-24
Brief Title:
Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The laparoscopic sleeve-gastrectomy SG compared to laparoscopic proximal Roux-Y-gastric bypass PGB is as successful in the treatment of morbid obesity in the majority of patients In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch BPD The resection of the gastric fundus LG leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus PGB
Detailed Description:
Background
Obesity is reaching epidemic proportions in the developed world In morbidly obese patients only surgical treatment bariatric operations leads to a sustained weight loss and cure of comorbidities in the majority of patients There exist a number of different operations resulting in either a restrictive effect andor malabsorption accompanied by a humoral effect which is caused by changes of the different gastrointestinal hormones It is still unknown which patients needs which operation
Working Hypothesis
The laparoscopic sleeve-gastrectomy SG compared to laparoscopic proximal Roux-Y-gastric bypass PGB is as successful in the treatment of morbid obesity in the majority of patients In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch BPD The resection of the gastric fundus LG leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus PGB
Specific Aims
We plan to compare the SG and PGB in a prospective randomized study Primary outcome measure is effectiveness in terms of weight loss reduction in co-morbidity and quality of life secondary outcome measures are early morbidity duration and cost of the operation late morbidity re-operations for complications for insufficient weight loss postoperative changes of gastrointestinal hormones
Experimental DesignMethods
An interdisciplinary team evaluates morbidly obese patients for bariatric surgery After informed consent eligible patients will be randomized into SG or PGB a number of 45 per group Preoperative examination consists of quantification of comorbidity eating behavior indirect calorimetry body composition by dual energy x-ray absorptiometry DEXA routine blood chemistry gastrointestinal hormones before and after test meal gastroscopy manometry of the esophagus upper GI series abdominal ultrasound quality of life Perioperative investigations operative time fat tissue samples omental and subcutaneous early morbidity gastrointestinal hormones before and after test meal duration of hospital stay costs Follow-up data will be obtained every 3 months in the first year twice in the second year and once per year thereafter weight reduction in comorbidities blood tests gastrointestinal hormones before and after test meal DEXA and quality of life
Obesity is reaching epidemic proportions in the developed world In morbidly obese patients only surgical treatment bariatric operations leads to a sustained weight loss and cure of comorbidities in the majority of patients There exist a number of different operations resulting in either a restrictive effect andor malabsorption accompanied by a humoral effect which is caused by changes of the different gastrointestinal hormones It is still unknown which patients needs which operation
Working Hypothesis
The laparoscopic sleeve-gastrectomy SG compared to laparoscopic proximal Roux-Y-gastric bypass PGB is as successful in the treatment of morbid obesity in the majority of patients In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch BPD The resection of the gastric fundus LG leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus PGB
Specific Aims
We plan to compare the SG and PGB in a prospective randomized study Primary outcome measure is effectiveness in terms of weight loss reduction in co-morbidity and quality of life secondary outcome measures are early morbidity duration and cost of the operation late morbidity re-operations for complications for insufficient weight loss postoperative changes of gastrointestinal hormones
Experimental DesignMethods
An interdisciplinary team evaluates morbidly obese patients for bariatric surgery After informed consent eligible patients will be randomized into SG or PGB a number of 45 per group Preoperative examination consists of quantification of comorbidity eating behavior indirect calorimetry body composition by dual energy x-ray absorptiometry DEXA routine blood chemistry gastrointestinal hormones before and after test meal gastroscopy manometry of the esophagus upper GI series abdominal ultrasound quality of life Perioperative investigations operative time fat tissue samples omental and subcutaneous early morbidity gastrointestinal hormones before and after test meal duration of hospital stay costs Follow-up data will be obtained every 3 months in the first year twice in the second year and once per year thereafter weight reduction in comorbidities blood tests gastrointestinal hormones before and after test meal DEXA and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None