Comparing conventional and tailored limb lengths in gastric bypass surgery
Randomized Controlled Trial on Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
This study is testing whether customizing the lengths of certain parts of gastric bypass surgery can help people lose more weight and improve their health compared to standard lengths.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | GEM Hospital & Research Center Academic / other |
| Locations | 1 site (Coimbatore, Tamil Nadu) |
| Trial ID | NCT06756789 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of tailoring limb lengths based on the 1/3rd and 2/3rd concept in Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery. Participants are divided into two groups: one receiving conventional limb lengths of 75cm and 125cm, and the other receiving tailored limb lengths according to their total small bowel length. The study aims to assess total percentage weight loss, improvement in BMI, and remission of obesity-related comorbidities during the follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI of 40 kg/m² or higher, or 35 kg/m² with obesity-related comorbidities.
Not a fit: Patients with previous bariatric surgery or severe cardiopulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved weight loss outcomes and better management of obesity-related health issues for patients.
How similar studies have performed: While the concept of tailored limb lengths is innovative, similar studies have not been widely reported, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Coimbatore, Tamil Nadu
- GEM Hospital and Research Center — Coimbatore, Tamil Nadu, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.