Skip to main content
OpenTrials
Completed

NCT Number: NCT01040507

Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

The main aim of this study is to analyze and report the very long-term outcomes after primary laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Fresno Center for Medical Education and Research, Department of Surgery

Fresno, California, 93701, United States

About this study

There is lack of very-long term outcomes after bariatric surgery; A few series have been reported. However, most of them analyze medium-term outcomes. For RYGB, there are just two retrospective cohort studies reporting very long-term outcomes. Both studies have an open approach and a proximal Roux-en-Y configuration with different pouch orientation and size. MacLean´s series, with a better follow-up rate (83.4%), had a 67.6%EWL at a mean of 11.4 years; Failure rates were 20 and 35% for the morbidly obese and super obese, respectively. We will analyze our own series with a laparoscopic approach, vertically, lesser-curve base < 10-15ml pouch and proximal Roux limb. The main end-points for our study are 1) Morbidity including status of specific biochemical markers & Mortality, 2) Weight loss expressed as BMI or %EWL, 3) Trends in major comorbidities and 4) Assessment of Quality of Life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who met NIH criteria for recommendation of a bariatric procedure with a combination of the following characteristics
  • status post primary laparoscopic proximal RYGB surgery with or without subsequent open or laparoscopic revisions or re-operations
  • follow up > 10.0 years (Very long term outcome)

Exclusion criteria

  • patients who had a previous gastric or bariatric procedure
  • patients who underwent primary laparoscopic RYGB somewhere else by other surgical group
  • missing records and/or unreachable patients with scant information for analysis

Treatment and study plan

Primary outcomes

  1. Weight loss expressed as Body Mass Index and Percentage excess weight loss

    Time frame: throughout follow-up

  2. Comorbidity status

    Time frame: throughout follow-up

  3. Health-related Quality of Life (HR-QoL)

    Time frame: at last follow-up

  4. Subjective satisfaction

    Time frame: at the last follow-up

  5. Morbidity and mortality

    Time frame: throughout follow-up

Secondary outcomes

  1. Nutritional and metabolic status

    Time frame: throughout follow-up

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: >10yrsRYGB

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 29, 2009
Registry last updated
Dec 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.