Actively Recruiting
Randomized Controlled Trial Comparing Conventional and Tailored Limb Lengths in Laparoscopic Roux-en-Y Gastric Bypass Surgery for Obesity
Led by GEM Hospital & Research Center · Updated on 2025-01-03
40
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether tailoring the lengths of certain sections of the small intestine during Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery improves outcomes compared to using conventional limb lengths. This study focuses on adults with obesity or metabolic disease who are candidates for bariatric surgery, aiming to assess total weight loss, improvement in body mass index (BMI), and remission of related health conditions over time. Participants are divided into two groups. One group undergoes the standard LRYGB surgery 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 receives a tailored approach where limb lengths are adjusted based on the total small bowel length, with the biliopancreatic limb set at 3/8th and the alimentary limb at 5/8th of one-third of the total bowel length. Both procedures create a small gastric pouch connected to the small intestine to reduce food intake and nutrient absorption. Throughout the follow-up period at 3, 6, and 12 months after surgery, researchers will measure the percentage of total weight loss and improvement in BMI. Participants will be monitored for changes in obesity-related conditions and overall clinical outcomes. The study ensures participants' safety and tracks their progress through scheduled assessments and evaluations over this time frame.
CONDITIONS
Official 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 condition such as type 2 diabetes, hypertension, or obstructive sleep apnea
- ASA physical status classification of 3 or less
- Ability and willingness to provide written informed consent and follow study procedures
- Previous attempts at weight loss through diet, exercise, or medical treatment documented
You will not qualify if you...
- Previous bariatric or major gastrointestinal surgery that could influence the results of LRYGB
- Severe heart or lung diseases posing high surgical risk, such as severe congestive heart failure or severe 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 or recent malignancy requiring treatment within the past 5 years, excluding 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 follow-up visits and dietary requirements after surgery
- Chronic use of medications that significantly affect weight or metabolism, including corticosteroids or antipsychotics
- Any other medical or surgical condition that investigators believe makes participation unsuitable
AI-Screening
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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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