Clinical trial NCT06756789: Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
Official title: Randomized Controlled Trial on Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Metabolic Disease
Bariatric Surgery Candidate
Metabolic Surgery
RYGB
Keywords: Obesity
RYGB
Bariatric surgery
Metabolic surgery
Metabolic syndrome
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Percentage of total weight loss (%TWL)
timeFrame: 3, 6 and 12 months
measure: Improvement in BMI
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: Improvement in Type 2 diabetes
timeFrame: 3, 6 and 12 months
measure: Improvement in Hypertension
timeFrame: 3, 6, 12 months
measure: Improvement in dyslipidemia
timeFrame: 3, 6, 12 months
measure: Nutritional status
timeFrame: 3, 6 and 12 months
measure: Quality of life of patient
timeFrame: 3, 6 and 12 months
measure: Surgical complications
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: GEM Hospital and Research Center
state: Tamil nadu
Study officials:
References: