Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293703
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Brief Title:
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes CLIMB II Study
Sponsor:
Salvador Navarrete
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes CLIMB II Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
CLIMB II
Brief Summary:
The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15 respectively of patients total small bowel length versus current standard practice using fixed lengths The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects The investigators hypothesize RYGB with ratio-adjusted limb lengths aRYGB will result in higher total weight loss and resolution of metabolic syndrome comorbidities including diabetes hyperlipidemia and hypertension compared to standard fixed-length RYGB sRYGB The study will also utilize the Short Form Rand 36-Item Health Survey SF36 to determine differences in postoperative quality of life metrics
Detailed Description:
This study will be a prospective randomized controlled trial with a 11 recruitment allocation ratio Patients will be randomized to Standard fixed-length RYGB sRYGB or ratio-adjusted limb lengths aRYGB once the total small bowel length TSBL is fully counted intraoperatively
sRYGB will serve as the control group which will utilize BP and roux limb lengths of 100cm and 100cm respectively For the treatment group aRYGB will incorporate a BP limb length measuring 30 and a roux limb of 15 of total small bowel length each
Outcomes to be investigated
Specific Aim 1 To determine significantly increased Total Weight Loss TWL after aRYGB compared to sRYGB in morbidly obese patients Given current understanding that weight loss after RYGB is mediated at least in part by a malabsorptive process the investigators hypothesize that TWL will be greater after aRYGB versus sRYGB As per standard of care at our institute routine postoperative follow-up in the multidisciplinary Bariatric clinic will occur every 6 months 14 days or more frequently as clinically indicated for the first two years postoperatively followed by yearly thereafter Weight will be recorded in kilograms and a BMI will be calculated by the ratio of patient weight in kilograms over patient height in meters squared Postoperative TWL will then be measured postoperatively at 6 12 24 60 months from surgery
Specific Aim 2 To compare rates of Diabetes Mellitus DM resolution between aRYGB Vs SRYGB by DM subgroup analysis Of the many metabolic changes that occur after bariatric surgery one of the most salient effects include a rapid and effective resolution of DM This has been extensively studied in context of various bariatric surgeries including RYGB by our institution as previously described by the STAMPEDE trial Significant reduction of HbA1C and improvement in insulin sensitivity was noted as early as six to 12 months postoperatively As such this study proposes measurement of the following two metrics at 6 12 24 60 months postoperatively 1 proportion of subjects achieving HbA1C less than or equal to 65 and 2 proportion of subjects able to wean andor discontinue glycemic control medications
Specific Aim 3 To investigate the relative postoperative efficacy of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity Metabolic syndrome is a constellation of diagnoses including Hypertension HTN and Hyperlipidemia HLD which posit significant risk of medical comorbidities such as DM coronary disease and strokes As such addressing these conditions in morbidly obese patients confers a significant health benefit and decreases overall morbidity This secondary outcome will be measured by comparing pre- versus postoperative serum lipid levels and proportion of patients requiring less antihypertensives 6 12 24 60 months postoperatively
Specific Aim 4 To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups
These secondary outcomes will be addressed comparing the vitamin levels between the groups at 6 12 24 60 months postoperatively
Additional outcomes proposed include evaluation of postoperative quality of life as captured by the Impact of Weight on Quality of Life-Lite-Clinical Trials IWQOL-Lite-CT survey as validated and effectively used in previous investigative bariatric studies Responses will be tracked and obtained preoperatively and at various postoperative time points including Post-Operative Day POD 30 15 days and POD 365 90 days The investigators will furthermore track postoperative complications and adverse events as measured by the Comprehensive Complications Index in addition to instances where additional bariatric surgical interventions are pursued
sRYGB will serve as the control group which will utilize BP and roux limb lengths of 100cm and 100cm respectively For the treatment group aRYGB will incorporate a BP limb length measuring 30 and a roux limb of 15 of total small bowel length each
Outcomes to be investigated
Specific Aim 1 To determine significantly increased Total Weight Loss TWL after aRYGB compared to sRYGB in morbidly obese patients Given current understanding that weight loss after RYGB is mediated at least in part by a malabsorptive process the investigators hypothesize that TWL will be greater after aRYGB versus sRYGB As per standard of care at our institute routine postoperative follow-up in the multidisciplinary Bariatric clinic will occur every 6 months 14 days or more frequently as clinically indicated for the first two years postoperatively followed by yearly thereafter Weight will be recorded in kilograms and a BMI will be calculated by the ratio of patient weight in kilograms over patient height in meters squared Postoperative TWL will then be measured postoperatively at 6 12 24 60 months from surgery
Specific Aim 2 To compare rates of Diabetes Mellitus DM resolution between aRYGB Vs SRYGB by DM subgroup analysis Of the many metabolic changes that occur after bariatric surgery one of the most salient effects include a rapid and effective resolution of DM This has been extensively studied in context of various bariatric surgeries including RYGB by our institution as previously described by the STAMPEDE trial Significant reduction of HbA1C and improvement in insulin sensitivity was noted as early as six to 12 months postoperatively As such this study proposes measurement of the following two metrics at 6 12 24 60 months postoperatively 1 proportion of subjects achieving HbA1C less than or equal to 65 and 2 proportion of subjects able to wean andor discontinue glycemic control medications
Specific Aim 3 To investigate the relative postoperative efficacy of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity Metabolic syndrome is a constellation of diagnoses including Hypertension HTN and Hyperlipidemia HLD which posit significant risk of medical comorbidities such as DM coronary disease and strokes As such addressing these conditions in morbidly obese patients confers a significant health benefit and decreases overall morbidity This secondary outcome will be measured by comparing pre- versus postoperative serum lipid levels and proportion of patients requiring less antihypertensives 6 12 24 60 months postoperatively
Specific Aim 4 To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups
These secondary outcomes will be addressed comparing the vitamin levels between the groups at 6 12 24 60 months postoperatively
Additional outcomes proposed include evaluation of postoperative quality of life as captured by the Impact of Weight on Quality of Life-Lite-Clinical Trials IWQOL-Lite-CT survey as validated and effectively used in previous investigative bariatric studies Responses will be tracked and obtained preoperatively and at various postoperative time points including Post-Operative Day POD 30 15 days and POD 365 90 days The investigators will furthermore track postoperative complications and adverse events as measured by the Comprehensive Complications Index in addition to instances where additional bariatric surgical interventions are pursued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None