Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, Gastric Bypass Surgeries

Launched by YALE UNIVERSITY · Dec 4, 2013

Keywords

ClinConnect Summary

This clinical trial is studying three different types of weight loss surgeries—gastric banding, laparoscopic sleeve gastrectomy, and gastric bypass—specifically for severely obese adolescents aged 14 to 19. The goal is to find out how safe and effective these surgeries are in the short and long term. It's important to know that this trial is not randomized, which means participants will choose their surgery type, often in consultation with their families and healthcare providers.

To be eligible for this trial, participants need to have made at least six months of efforts to manage their weight and be approved for surgery by a specialized clinic. They should have a body mass index (BMI) of 35 or higher with related health issues, or a BMI of 40 or higher. Participants must also be committed to following specific nutritional guidelines after surgery and agree to avoid pregnancy for at least a year afterward. It's important for potential participants to have a supportive family environment and the ability to make informed decisions about their treatment. If you’re considering this trial, it’s a good idea to discuss it thoroughly with your family and healthcare team to understand the process and what to expect.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Youth 14-19yrs
• • 6 months of attempts at weight management by primary care physician or Pediatric Endocrinologist
• • Approval by the Adolescent Bariatric Surgery clinic to undergo surgery
• • Physically or nearly physically mature
• • BMI \>= 35kg/m2 with one obesity related comorbidities or BMI \>= 40 kg/m2
• • Commitment to avoid pregnancy for at least 1 year postoperatively
• • Capability and willingness to adhere to nutritional guidelines postoperatively
• • Informed consent to surgical treatment
• • Demonstration of decisional capacity
• • Supportive family environment
• Exclusion Criteria:
• • Inability to be approved by Yale Adolescent Bariatric Surgery clinic to undergo surgery
• • Uncontrolled psychosis
• • Uncontrolled depression
• • Drug or alcohol abuse
• • History of congenital or acquired anomalies of gastrointestinal tract
• • Esophageal anatomical abnormality or dysmotility
• • Inflammatory bowel disease
• • Severe cardiopulmonary disease
• • Severe coagulopathy
• • Hepatic insufficiency or cirrhosis
• • Presence of localized or systemic infection at time of surgery
• • Obesity related to central causes: Prader Willi and hypothalamic abnormalities
• • Non-compliance to nutrition plan, exercise, and behavioral counseling/treatment
• • Pregnant, breast-feeding or planning of becoming pregnant within 1-2 years of surgery