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

Last updated: December 30, 2024
Sponsor: GEM Hospital & Research Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Metabolic Disorders

Diabetes Prevention

Treatment

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

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

Clinical Study ID

NCT06756789
GemBariatricRYGB
  • Ages 18-65
  • All Genders

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 Criteria

Inclusion

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 andcomply with procedures.

  5. Previous Weight Loss Attempts: Documentation of previous attempts at weight lossthrough diet, exercise, or medical management.

Exclusion

Exclusion Criteria:

  1. Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery thatmight affect the outcome of RYGB.

  2. Severe Cardiopulmonary Conditions: Significant cardiac or pulmonary conditions thatpose a high surgical risk (e.g., severe congestive heart failure, severe chronicobstructive pulmonary disease).

  3. Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuseissues that are not well-controlled, including eating disorders.

  4. Pregnancy: Current pregnancy or plans to become pregnant within 12 monthspost-surgery.

  5. Malignancy: Active malignancy or history of malignancy requiring treatment in thepast 5 years (excluding non-melanoma skin cancer).

  6. Severe Liver Disease: Cirrhosis or significant liver dysfunction (e.g., Child-Pugh Bor C).

  7. Inability to Comply: Patients who are unable or unwilling to comply with thepostoperative follow-up schedule and dietary requirements.

  8. Chronic Use of Medications: Chronic use of medications known to affect weight ormetabolism significantly, such as corticosteroids or antipsychotics.

  9. Other Medical Conditions: Any other medical condition or surgical finding that, inthe opinion of the investigators, would make the patient unsuitable for the study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • GEM Hospital and Research Center

    Coimbatore, Tamil nadu 641045
    India

    Active - Recruiting

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