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Clinical Trials in India / NCT06756789
Recruiting Not applicable

Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery

NCT06756789 · tracked via the Priya Life Science India tracker
Sponsor
GEM Hospital & Research Center
Phase
Not applicable
Started
2024-04-01
Last updated
2025-01-03

Condition(s) studied

ObesityMetabolic DiseaseBariatric Surgery CandidateMetabolic SurgeryRYGB

Investigational drug(s) / intervention(s)

Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approachLaparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach

Laparoscopic 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

Laparoscopic 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
GEM Hospital and Research Center Coimbatore Tamil Nadu Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06756789 on ClinicalTrials.gov ↗ ← All trials in India