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Randomized Controlled Trial on Conventional Versus Tailored Limb Lengths in Laparoscopic Roux-en-Y Gastric Bypass Surgery
Led by GEM Hospital & Research Center · Updated on 2025-01-03
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate whether adjusting limb lengths based on the one-third and two-thirds concept improves outcomes in patients undergoing Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery, compared to the usual limb lengths. The study focuses on adults aged 18 to 65 years who are candidates for bariatric surgery due to obesity and related metabolic conditions. Researchers will compare clinical outcomes like weight loss, BMI improvement, and remission of comorbidities over a year. Two groups are studied: one receives the standard LRYGB procedure with fixed limb lengths of 75 cm for the biliopancreatic limb and 125 cm for the alimentary limb, regardless of total bowel length. The other group undergoes a tailored approach where limb lengths are adjusted based on the total small bowel length, with the biliopancreatic limb set as three-eighths and the alimentary limb as five-eighths of one-third of the total bowel length. Both procedures involve creating a small gastric pouch connected to the small intestine to reduce food intake and nutrient absorption. Participants will be followed up at 3, 6, and 12 months after surgery. During these visits, researchers will assess total weight loss percentage, BMI changes, improvements in type 2 diabetes, hypertension, and dyslipidemia, nutritional status, quality of life, and any surgical complications. The study uses randomized assignment to groups and double-blind methods to ensure reliable results. The total participation duration is about one year from surgery to final assessments.
CONDITIONS
Brief Title
Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Body Mass Index (BMI) of 40 kg/m² or higher, or BMI of 35 kg/m² or higher with at least one obesity-related comorbidity such as type 2 diabetes, hypertension, or obstructive sleep apnea
- American Society of Anesthesiologists (ASA) score less than or equal to 3
- Ability and willingness to provide written informed consent and follow study procedures
- Documented previous attempts at weight loss through diet, exercise, or medical management
You will not qualify if you...
- Previous bariatric or major gastrointestinal surgery affecting Roux-en-Y Gastric Bypass outcomes
- Severe cardiac or pulmonary conditions posing high surgical risk, like severe congestive heart failure or chronic obstructive pulmonary disease
- Uncontrolled psychiatric disorders or substance abuse, including eating disorders
- Current pregnancy or plans to become pregnant within 12 months after surgery
- Active malignancy or cancer treatment within the past 5 years, except for non-melanoma skin cancer
- Severe liver disease such as cirrhosis or significant liver dysfunction (Child-Pugh B or C)
- Inability or unwillingness to comply with postoperative follow-up and dietary requirements
- Chronic use of medications significantly affecting weight or metabolism, like corticosteroids or antipsychotics
- Any other medical or surgical condition that investigators consider makes the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo laparoscopic Roux-en Y gastric bypass surgery using either conventional or tailored limb lengths, followed by immediate post-operative care.
1 surgical procedure and hospital stay
Duration - 12 months
Participants are monitored for surgical complications and progress with weight loss and health improvements.
Visits at 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
GEM Hospital and Research Center
Coimbatore, Tamil Nadu, India, 641045
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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