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

Not Applicable

Recruiting

• Conditions: Obesity; Metabolic Disease; Bariatric Surgery Candidate; Metabolic Surgery; RYGB

• Registration Number: NCT06756789
• Lead Sponsor: GEM Hospital & Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-06-26
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-05-31
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of total weight loss (%TWL)	3, 6 and 12 months
Improvement in BMI	3, 6 and 12 months	BMI is calculated by dividing Weight in kilogram by height in square meters. This is calculated at 3,6 and 12 month intervals and BMI is calculated at each point of time. Improvement in BMI when compared to the pre-operative BMI is calculated for both the groups and analysed.

Secondary Outcome Measures

Name	Time	Method
Surgical complications	3, 6 and 12 months	Includes postoperative bleeding, 30 day readmission, Leaks, Re-exploration
Improvement in Type 2 diabetes	3, 6 and 12 months	HbA1c for Type 2 diabetes
Improvement in Hypertension	3, 6, 12 months	Blood pressure measurement for Hypertension
Improvement in dyslipidemia	3, 6, 12 months	Lipid profiles for dyslipidemia
Nutritional status	3, 6 and 12 months	Assessed with the skeletal muscle mass
Quality of life of patient	3, 6 and 12 months	SF (Short Form) 36 questionnaire

Trial Locations

Locations (1)

GEM Hospital and Research Center; 🇮🇳 Coimbatore, Tamil nadu, India