Adding Malabsorption for Failed Gastric Bypass

NCT01040481 | Completed DMC

• 2 other identifiers: CMC IRB No. 2009066U1111-1113-0500
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to analyze and report the preliminary and intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3) Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized, non-validated subjective satisfaction questionnaire and the validated, disease-specific, Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity \& Mortality including nutritional status and metabolic complications. Consequently, secondary objectives of this study are 1) to assess failure rate defined as percentage of excess weight loss \< 50% , lowest BMI \>35 for morbidly obese (MO) or \>40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessing preliminary and intermediate results after the surgery under analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters. This research is in line with the most current provocative new ideas and recent high impact publications. To the best of our knowledge, this is the very first outcome study of revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass. Previously, several studies have addressed conversion to malabsorptive gastric bypass after a failed primary proximal gastric bypass but none has addressed the failed distal gastric bypass nor the adequate balance between increasing restriction and malabsorption for decreasing the risk of protein-calorie malnutrition.

Conditions

Clinically Severe Obesity; Obesity Recidivism; Inadequate Initial Weight Loss; Poor Weight Loss; Persistent Obesity; Refractory Obesity; Intractable Obesity

Keywords

Failed gastric bypass; Malabsorptive distal gastric bypass; Distal gastric bypass; Malabsorptive gastric bypass; Adding malabsorption; Increasing malabsorption; Re-operative bariatric surgery; Revisional bariatric surgery; Revisional gastric bypass; Reoperations; Conversions

Outcome Measures

Primary Outcomes (2)

• Morbidity and mortality

  throughout follow-up

• Weight loss expressed as Body Mass Index and Percentage excess weight loss

  throughout follow-up

Secondary Outcomes (4)

• Traditional outcome measurements

  Variable

• Remission or improvement of comorbidities

  throughout follow-up

• Health-related Quality of Life (HR-QoL)

  at last follow-up

• Subjective Satisfaction

  at the last follow-up

Study Arms (1)

Malabsorptive distal gastric bypass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had either clinically severe obesity (morbid obesity, MO, or super obesity, SO) underwent a primary Roux-en-Y gastric bypass. The ones that were subsequently revised ending up with an optimized malabsorptive distal gastric bypass were identified from our prospectively maintained bariatric database and included in this study. Specific metabolic and nutritional complications after RYGB surgery were defined according to standard definitions based on signs, symptoms, and laboratory measurements.

You may qualify if:

• Patients who met NIH criteria for recommendation of a bariatric procedure with the combination of the following characteristics:
• Failed primary proximal gastric bypass with subsequent revision to a malabsortive distal gastric bypass.
• Failed primary distal malabsorptive gastric bypass with subsequent revision to increase the restrictive component (revisional: gastroplasty, Fobi, or adjustable gastric band)

You may not qualify if:

• Patients with prior major conversions or revisions.
• Missing records and/or unreachable patients with scant information for analysis.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

Location

Related Publications (33)

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• http://www.asbs.org/htm/Private/resolution.html. American Society for Metabolic and Bariatric Surgeons.

  BACKGROUND

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• Brolin RE, Cody RP. Adding malabsorption for weight loss failure after gastric bypass. Surg Endosc. 2007 Nov;21(11):1924-6. doi: 10.1007/s00464-007-9542-z. Epub 2007 Sep 3.

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• Pareja JC, Pilla VF, Callejas-Neto F, Coelho-Neto Jde S, Chaim EA, Magro DO. [Gastric bypass Roux-en-Y gastrojejunostomy--conversion to distal gastrojejunoileostomy for weight loss failure--experience in 41 patients]. Arq Gastroenterol. 2005 Oct-Dec;42(4):196-200. doi: 10.1590/s0004-28032005000400002. Epub 2006 Jan 19. Portuguese.

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco M Tercero, MD

  Research Associate, University of California San Francisco

  STUDY DIRECTOR

• Kelvin D Higa, MD

  Professor of Surgery, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2009
• First Posted: December 29, 2009
• Study Start: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

US (1)