Bariatric Surgery for ESRD Patients vs Control

Not Applicable

Terminated

• Conditions: ESRD; Obesity
• Interventions: Procedure: Roux-en-y gastric bypass (RYGB)

• Registration Number: NCT00580762
• Lead Sponsor: Yale University

Brief Summary

This study will address a true clinical problem by developing a risk/benefit analysis for rapid surgical weight loss in the ESRD population. The risks of surgical intervention, as well as, potential nutritional concerns, balanced with that of the potential medical benefits associated with significant weight loss.

Detailed Description

The study will be designed to compare two cohorts of patients that will undergo laparoscopic RYGB. Cohort 1 will include ESRD patients on HD who meet the NIH guidelines and preoperative requirements for RYGB. Cohort 2 will include non-ESRD patients who meet the NIH guidelines and preoperative requirements for RYGB. Laparoscopic RYGB will be performed in ESRD patients who meet the guidelines recommended by the National Institutes of Health consensus statement . This includes patients who either have a BMI≥40 kg/m2 or have a BMI≥35 kg/m2 and have a significant morbidity attributed to their obesity (i.e. sleep apnea, hypertension, and diabetes mellitus). All patients will undergo a complete pre-operative evaluation inclusive of dietary instruction, assessment of surgical risk, psychosocial evaluation and compliance evaluation. This evaluation will be conducted through an existing infrastructure at the investigators Bariatric Surgery Center. Patients will be required to be on hemodialysis or able to be converted to hemodialysis for the perioperative period. All procedures will be performed by the same team of surgeons, experienced in both laparoscopic RYGB, organ transplantation and general surgery in ESRD patients. The risks involved with Roux-en-Y gastric bypass surgery will be discussed with the patient. These risks are inherent to the procedure, however the procedure is being conducted for medical appropriate reasons and therefore the benefits to the procedure outweigh the risks. At the present time, it is believed, without any justification, that this procedure is more risky or too risky in the ESRD population. A primary objective of this study is to investigate this question.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-27
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Obese ESRD patients with a BMI≥ 40kg/m2 or ≥35kg/m2 with an medical complication attributed to morbid obesity (NIH guidelines).REF
2. Age ≥ 18 and ≤ 65
3. Patients must be on hemodialysis for one month.
4. Patients listed for kidney transplant in a UNOS certified kidney transplant center.
5. Patients have accrued less than 18 months of waiting time.
6. Completion of pre-RYGB psychosocial evaluation.
7. Completion of pre-RYGB dietary counseling.
8. Completion of pre-RYGB surgical risk assessment inclusive of cardiac evaluation.
9. Full reciprocal understanding of informed consent and the risks and benefits of RYGB procedure.
10. Acceptance of clinical protocol evaluations requiring scheduled clinic visits and laboratory blood draws.

Exclusion Criteria

1. Age < 18 and > 65.
2. Patients with a history of peritoneal dialysis related bacterial peritonitis.
3. Peritoneal dialysis patients not willing to undergoing temporary hemodialysis.
4. History of difficult vascular access as defined by the inability to obtain permanent upper extremity or temporary jugular venous access.
5. History of poor hemodialysis performance.
6. Patients enrolled in another study within 6 months of initiation.
7. Patients listed for kidney transplant in a different UNOS region that has shorter transplant waiting times than the region governing the investigators institution.
8. Patients unwilling to be made temporarily unavailable for transplant.
9. History of non-compliance with medical care.
10. Uncontrolled psychiatric illness (ie. depression, anxiety, attention deficit disorder (ADD), uncontrolled binge eating disorder)
11. Inability to provide reciprocal understanding of informed consent.
12. Failure to complete the preoperative work-up (psychosocial, dietary and surgical risk) for RYGB.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESRD	Roux-en-y gastric bypass (RYGB)	End-Stage Renal Disease (ESRD) patients on dialysis who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB
Non-ESRD	Roux-en-y gastric bypass (RYGB)	Non-ESRD patients who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB

Primary Outcome Measures

Name	Time	Method
The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed.	1 year

Secondary Outcome Measures

Name	Time	Method
Weight reduction in ESRD patients will be characterized to assess additive risk factors for micronutrient abnormalities and protein malnutrition.	1 year

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States