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The study aims to investigate whether tailoring limb lengths based on the 1/3rd and 2/3rd concept improves clinical outcomes in Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional limb lengths. In this study, two groups were described, first group involves patients who will undergo Lap RYGB with conventional limb lengths of 75cms and 125cms, while the second group is given tailored limb lengths according to the total small bowel length. In the follow up period, Total percentage weight loss, improvement in BMI along with the remission of co-morbidities were also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional group | Placebo Comparator | In this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length |
|
| Tailored group | Active Comparator | In this arm, limb lengths are tailored according to the total small bowel length, 1/3rd of the total bowel length is measured and in that 3/8th and 5/8th were kept as BP limb and alimentary limb respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach | Procedure | The procedure involves creating a small gastric pouch from the upper portion of the stomach, which is then directly connected to the small bowel, in a roux- enY fashion with another jejune-jejunal anastamosis bypassing a large part of the stomach and the duodenum. This results in reduced food intake and decreased nutrient absorption. In this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total weight loss (%TWL) | 3, 6 and 12 months | |
| Improvement in BMI | BMI is calculated by dividing Weight in kilogram by height in square meters. This is calculated at 3,6 and 12 month intervals and BMI is calculated at each point of time. Improvement in BMI when compared to the pre-operative BMI is calculated for both the groups and analysed. | 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Type 2 diabetes | HbA1c for Type 2 diabetes | 3, 6 and 12 months |
| Improvement in Hypertension | Blood pressure measurement for Hypertension |
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Inclusion Criteria:
Age: 18-65 years
Body Mass Index (BMI):
BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea).
ASA - less than or equal to 3
Informed Consent: Ability and willingness to provide written informed consent and comply with procedures.
Previous Weight Loss Attempts: Documentation of previous attempts at weight loss through diet, exercise, or medical management.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GEM Hospital and Research Center | Recruiting | Coimbatore | Tamil Nadu | 641045 | India |
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|
| Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach | Procedure | The procedure involves creating a small gastric pouch from the upper portion of the stomach, which is then directly connected to the small bowel, in a roux- enY fashion with another jejune-jejunal anastamosis bypassing a large part of the stomach and the duodenum. This results in reduced food intake and decreased nutrient absorption. In this arm, limb lengths are tailored according to the total small bowel length, 1/3rd of the total bowel length is measured and in that 3/8th and 5/8th were kept as BP limb and alimentary limb respectively. |
|
| 3, 6, 12 months |
| Improvement in dyslipidemia | Lipid profiles for dyslipidemia | 3, 6, 12 months |
| Nutritional status | Assessed with the skeletal muscle mass | 3, 6 and 12 months |
| Quality of life of patient | SF (Short Form) 36 questionnaire | 3, 6 and 12 months |
| Surgical complications | Includes postoperative bleeding, 30 day readmission, Leaks, Re-exploration | 3, 6 and 12 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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