Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
Recruiting · NCT06756789 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approachLaparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age: 18-65 years
- 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).
- ASA - less than or equal to 3
- Informed Consent: Ability and willingness to provide written informed consent and comply with procedures.
- Previous Weight Loss Attempts: Documentation of previous attempts at weight loss through diet, exercise, or medical management.
Exclusion criteria
- Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery that might affect the outcome of RYGB.
- 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).
- Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders.
- Pregnancy: Current pregnancy or plans to become pregnant within 12 months post-surgery.
- Malignancy: Active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer).
- Severe Liver Disease: Cirrhosis or significant liver dysfunction (e.g., Child-Pugh B or C).
- Inability to Comply: Patients who are unable or unwilling to comply with the postoperative follow-up schedule and dietary requirements.
- Chronic Use of Medications: Chronic use of medications known to affect weight or metabolism significantly, such as corticosteroids or antipsychotics.
- 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 it is running
1 location listed.
- GEM Hospital and Research Center - Coimbatore, Tamil Nadu, India