NCT06756789 Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
| NCT ID | NCT06756789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GEM Hospital & Research Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-01 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06756789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06756789 currently recruiting?
Yes, NCT06756789 is actively recruiting participants. Visit ClinicalTrials.gov or contact GEM Hospital & Research Center to inquire about joining.
Where is the NCT06756789 trial being conducted?
This trial is being conducted at Coimbatore, India.
Who is sponsoring the NCT06756789 clinical trial?
NCT06756789 is sponsored by GEM Hospital & Research Center. The trial plans to enroll 40 participants.
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