Bariatric Surgery Candidate, Metabolic Disease, Metabolic Surgery, Obesity, RYGB
Conditions
Keywords
Obesity, RYGB, Bariatric surgery, Metabolic surgery, Metabolic syndrome
Brief summary
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.
Interventions
PROCEDURELaparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach
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
PROCEDURELaparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach
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.
Sponsors
GEM Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-65 years 2. 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). 3. ASA - less than or equal to 3 4. Informed Consent: Ability and willingness to provide written informed consent and comply with procedures. 5. Previous Weight Loss Attempts: Documentation of previous attempts at weight loss through diet, exercise, or medical management.
Exclusion criteria
1. Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery that might affect the outcome of RYGB. 2. Severe Cardiopulmonary Conditions: Significant cardiac or pulmonary conditions that pose a high surgical risk (e.g., severe congestive heart failure, severe chronic obstructive pulmonary disease). 3. Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders. 4. Pregnancy: Current pregnancy or plans to become pregnant within 12 months post-surgery. 5. Malignancy: Active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer). 6. Severe Liver Disease: Cirrhosis or significant liver dysfunction (e.g., Child-Pugh B or C). 7. Inability to Comply: Patients who are unable or unwilling to comply with the postoperative follow-up schedule and dietary requirements. 8. Chronic Use of Medications: Chronic use of medications known to affect weight or metabolism significantly, such as corticosteroids or antipsychotics. 9. Other Medical Conditions: Any other medical condition or surgical finding that, in the opinion of the investigators, would make the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of total weight loss (%TWL) | 3, 6 and 12 months | — |
| Improvement in BMI | 3, 6 and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in dyslipidemia | 3, 6, 12 months | Lipid profiles for dyslipidemia |
| Nutritional status | 3, 6 and 12 months | Assessed with the skeletal muscle mass |
| Improvement in Type 2 diabetes | 3, 6 and 12 months | HbA1c for Type 2 diabetes |
| Surgical complications | 3, 6 and 12 months | Includes postoperative bleeding, 30 day readmission, Leaks, Re-exploration |
| Quality of life of patient | 3, 6 and 12 months | SF (Short Form) 36 questionnaire |
| Improvement in Hypertension | 3, 6, 12 months | Blood pressure measurement for Hypertension |
Countries
India
Outcome results
None listed