Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass

NCT01040533 | Completed DMC

• 2 other identifiers: CMC IRB No. 2008085U1111-1112-9885
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study objectives are the following.

• To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB).
• To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss.
• To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.

Conditions

Clinically Severe Obesity; Metabolic Complications After Jejunoileal Bypass; Nutritional Complications After Jejunoileal Bypass; Obesity Recidivism; Inadequate Initial Weight Loss; Intestinal Malabsorptive Syndrome; Protein Malnutrition

Keywords

Failed jejunoileal bypass; Complicated jejunoileal bypass; Revision gastric bypass; Revisional surgery; Reoperations; Metabolic and nutritional complications

Outcome Measures

Primary Outcomes (4)

• Morbidity and mortality

  throughout follow-up

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

  throughout follow-up

• Remission or improvement of symptoms and JIB-related complications

  throughout follow-up

• Remission or improvement of other comorbidities

  throughout follow-up

Secondary Outcomes (3)

• Operative time

  transoperatively

• conversion to open approach

  transoperatively

• Hospital stay

  same hospitalization

Study Arms (1)

Failed / complicated jejunoileal 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 underwent laparoscopic revision of JIB to Roux-en-Y gastric bypass (RYGB) for poor weight loss or JIB-related late complications were analyzed. Failed or JIB-related late complications, mostly metabolic, were considered for surgical intervention after optimized medical multidisciplinary management

You may qualify if:

• Met NIH criteria for weight loss surgery with poor weight loss after JIB
• Intractable, severe and/or recurrent JIB-related late complications after optimized medical management
• Laparoscopic approach for primary revisional bariatric surgery

You may not qualify if:

• Any other type of revisional bariatric procedure
• Open approach for revision surgery
• 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, Department of Surgery

Fresno, California, 93701, United States

Location

Related Publications (28)

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  PMID: 17828427 BACKGROUND

• Bradley JE, Brown RO, Luther RW. Multiple nutritional deficiencies and metabolic complications 20 years after jejunoileal bypass surgery. JPEN J Parenter Enteral Nutr. 1987 Sep-Oct;11(5):494-8. doi: 10.1177/0148607187011005494.

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• Wands JR, LaMont JT, Mann E, Isselbacher KJ. Arthritis associated with intestinal-bypass procedure for morbid obesity. Complement activation and characterization of circulating cryoproteins. N Engl J Med. 1976 Jan 15;294(3):121-4. doi: 10.1056/NEJM197601152940301.

  PMID: 1105187 BACKGROUND

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• LaFave JW, Alden JF. Gastric bypass in the operative revision of the failed jejunoileal bypass. Arch Surg. 1979 Apr;114(4):438-44. doi: 10.1001/archsurg.1979.01370280092013.

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• Griffen WO Jr, Hostetter JM, Bell RM, Bivins BA, Bannon C. Experiences with conversion of jejunoileal bypass to gastric bypass: its use for maintenance of weight loss. Arch Surg. 1981 Mar;116(3):320-4. doi: 10.1001/archsurg.1981.01380150048013.

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• Ackerman NB. Metabolic consequences from conversion of jejunoileal bypass to gastric bypass. Ann Surg. 1982 Nov;196(5):553-9. doi: 10.1097/00000658-198211000-00007.

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• Dallal RM, Akhondzadeh M. Minimally invasive management of complications from jejunoileal bypass. Surg Obes Relat Dis. 2006 Mar-Apr;2(2):226-7. doi: 10.1016/j.soard.2006.01.006. Epub 2006 Feb 28. No abstract available.

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• O'Brien P, Brown W, Dixon J. Revisional surgery for morbid obesity--conversion to the Lap-Band system. Obes Surg. 2000 Dec;10(6):557-63. doi: 10.1381/096089200321594174.

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  PMID: 18065288 BACKGROUND

Related Links

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MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

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: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

US (1)