Clinically Severe ObesityNCT01040481
Adding Malabsorption for Failed Gastric Bypass
An observational study of Clinically Severe Obesity and Obesity Recidivism, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clinically Severe Obesity, Obesity Recidivism, Inadequate Initial Weight Loss
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients with prior major conversions or revisions.
- Missing records and/or unreachable patients with scant information for analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Fresno Center for Medical Education and Research
Fresno, California, 93701
About this study
Official title: Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass
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.
Read the detailed description
Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery (ASMBS) reported that 81% of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80% of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1% of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20% of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure11. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner. RYGB is consistently considered the revisional procedure of choice for failed restrictive procedures.
At present there are three broad categories of bariatric procedures according to its mechanism of action: 1) purely restrictive, 2) primarily restrictive with some malabsorption, and 3) primarily malabsorptive with some restriction. Modern standard bariatric procedures recognized by the American Society for Metabolic and Bariatric Surgery "ASMBS" include the following 1) adjustable gastric band, 2) sleeve gastrectomy, 3) gastric bypass, 4) biliopancreatic diversion, and 5) duodenal switch.
In general, there is a lack of long-term (5-10 years) and very long-term (> 10 years) outcome studies for modern bariatric surgery that would allow us to better define the role of each one of these procedures, especially after the advent of the laparoscopic approach.
In an animal model, diet induced obese animals exhibiting metabolic syndrome underwent Roux-en-Y gastric bypass with highly reproducible surgical outcomes as well as biochemical and energetic homeostatic abnormalities similar to post-RYGB findings in humans. Weight regain occurs in approximately 20% of patients after two to three years after RYGB. It seems that the weight-loss-promoting effects of chronically elevated plasma PYY concentrations dominate the weight-gain-promoting effects of lowered plasma leptin concentrations, with the relative plasma PYY: leptin concentration ratio determining whether weight loss will be sustained or regained.
Several studies have compared different Roux limb lengths in primary bariatric surgery. It seems to be that long limb RYGB (150cm), especially in patients with BMI > 50 kg/m2, confers at least better short-term weight loss without nutritional consequences. Conversely, other investigators have not found any clinically significant difference in weight loss with increasing Roux limb lengths, especially in patients with BMI < 50 kg/m2 23-26. The following are the main investigators that have increased the malabsorptive component of the failed proximal gastric bypass as a revisional strategy:
- Torres JC in 1991 was the first to propose this strategy with a cohort of 140 patients followed for 5 years (90.5% follow-up rate). Analyzed traditional outcome measures were early (2.1%) and late (27%) morbidity including protein-calorie malnutrition (7%); %EWL at 1,2,3,4,and 5 years were 89.5%, 91%, 87%, 82.5%, 82.5%, respectively; and re-operations.
- Fox SR and Oh KH et al in 1996 reported 10 failed proximal gastric bypass patients undergoing distal gastric bypass from an diverse group of failed primary surgeries (n=80) followed for 3 years with a 92.5% follow-up rate. Reported traditional outcome measures were early (39%) and late (84%) morbidity; %EWL at 1,2,\&3 years was 83%, 89%and 94%, respectively; high satisfaction was also reported.
- Sugerman et al in 1997 published their outcomes with 27 patients. Five patients were converted to a malabsortive distal gastric bypass with a 50cm common channel which required a second revision for malnutrition and two died. 22 patients were revised to a 150cm common channel; three patients required a second revision for malnutrition but %EWL went from 30% to 61% at 1 year and 69% at 5 years. They concluded that a 50cm common channel had an unacceptable morbidity and mortality.
- Fobi et al in 2000 presented his results of 65 patients after mostly failed primary Fobi pouch operation. 15 patients developed protein calorie malnutrition requiring supplemental nutrition and 6 required further revision.
- The 2001 Sapala´s et al partial outcome analysis on 303 varied revisionary micropouch gastric bypass procedures with a 200cm Roux limb, 150cm biliopancreatic limb and >200cm common channel. %EWL during 3 years is similar to the primary procedure (68.6%, 76.6%, and 72.3%). However no subset analysis is performed.
- Pareja et al analysis of 41 patients, undergoing diverse distal malabsorptive techniques, included 32 revisionary procedures after primary Fobi-Capella gastric bypass. At 11, 16, and 19 months of mean follow-up, %EWL for the Scopinaro-style, Brolin, and Fobi revisionary gastric bypasses were 69.7%, 65.0%, 74.8%, respectively. Failure and success rates according to Biron et al. are provided but no other subgroup analysis is provided.
- Brolin et al on 2007 reported 47 out of 54 patients undergoing revision for failed primary bariatric surgery had a very, very long limb gastric bypass with a 75cm to 100cm common channel and a 15cm to 25cm biliopancreatic limb. 7.4% (n=4) developed protein-calorie malnutrition from which one required 6 weeks of TPN, two elongation of the common channel (150cm) and one reversal after a prolonged hiatus returning with severe metabolic complications. 47.9% of the series lost at least 50% EWL at 1 year. There was no difference between those with primary failed restrictive vs. primary failed gastric bypass patients.
- Sarr et al on 2007 states that "patients with anatomically intact, non-malabsorptive RYGB when converted to a malabsortive distal RYGB, good results are not common".
To the best of our knowledge and after extensive literature search, there is no outcome study employing a laparoscopic approach for revisional malabsorptive distal Roux-en-Y gastric bypass specially increasing the restrictive component in a failed primary malabsorptive distal type of gastric bypass. Thus, we decided to analyze our own series including the learning curve and diverse revisional techniques in this unique subset of patients: 1) revision gastroplasty; 2) Fobi-Capella (static band); 3) Adjustable gastric band; 4) Conversion to either modality of malabsorptive distal gastric bypass, very, very long limb or distal.
Summarizing, there is lack of very-long term outcomes after bariatric surgery and standardization of gastric bypass surgery. The treatment of inadequate weight loss or weight recidivism after Roux-en-Y gastric bypass (RYGB) remains refractory to medical treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese and super obese, respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of procedure to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We analyze our experience with the laparoscopic approach to these complex and challenging patients.
- Conditions
- Clinically Severe Obesity, Obesity Recidivism, Inadequate Initial Weight Loss, Poor Weight Loss, Persistent Obesity, Refractory 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malabsorptive distal gastric bypass | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity and mortality
Measured: throughout follow-up
Weight loss expressed as Body Mass Index and Percentage excess weight loss
Measured: throughout follow-up
Secondary outcomes (4)
Traditional outcome measurements
Measured: Variable
Remission or improvement of comorbidities
Measured: throughout follow-up
Health-related Quality of Life (HR-QoL)
Measured: at last follow-up
Subjective Satisfaction
Measured: at the last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Clinically Severe ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Francisco M Tercero, MD, Study director, Research Associate, University of California San FranciscoKelvin D Higa, MD, Principal investigator, Professor of Surgery, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040481
- Sponsor's protocol ID
- CMC IRB No. 2009066
- Other IDs
- U1111-1113-0500
- Status last verified
- Dec 2009
- First submitted
- 26 Dec 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Higa KD, Boone KB, Ho T, Davies OG. Laparoscopic Roux-en-Y gastric bypass for morbid obesity: technique and preliminary results of our first 400 patients. Arch Surg. 2000 Sep;135(9):1029-33; discussion 1033-4. doi: 10.1001/archsurg.135.9.1029.
PubMed 10982506Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
PubMed 15199035McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, Lohr KN. Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Dec 2;139(11):933-49. doi: 10.7326/0003-4819-139-11-200312020-00013.
PubMed 14644897Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. doi: 10.1097/01.sla.0000137343.63376.19.
PubMed 15319713Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
PubMed 17715409Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
PubMed 17715408Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008 Sep;14(9):589-96.
PubMed 18778174Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. doi: 10.1001/jama.294.15.1909.
PubMed 16234497Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. doi: 10.1001/jama.298.12.1442. No abstract available.
PubMed 17895461Meguid MM, Glade MJ, Middleton FA. Weight regain after Roux-en-Y: a significant 20% complication related to PYY. Nutrition. 2008 Sep;24(9):832-42. doi: 10.1016/j.nut.2008.06.027.
PubMed 18725080Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. doi: 10.1007/s00464-007-9572-6. Epub 2007 Sep 8. No abstract available.
PubMed 17828427http://www.asbs.org/htm/Private/resolution.html. American Society for Metabolic and Bariatric Surgeons.
O'Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006 Aug;16(8):1032-40. doi: 10.1381/096089206778026316.
PubMed 16901357Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
PubMed 7677463
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass
- ClinicalTrials.gov ID
- NCT01040481
- Acronym / sponsor ID
- CMC IRB No. 2009066
- Conditions
- Clinically Severe Obesity, Obesity Recidivism, Inadequate Initial Weight Loss, Poor Weight Loss, Persistent Obesity, Refractory 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery (ASMBS) reported that 81% of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80% of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1% of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20% of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure11. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner. RYGB is consistently considered the revisional procedure of choice for failed restrictive procedures.
At present there are three broad categories of bariatric procedures according to its mechanism of action: 1) purely restrictive, 2) primarily restrictive with some malabsorption, and 3) primarily malabsorptive with some restriction. Modern standard bariatric procedures recognized by the American Society for Metabolic and Bariatric Surgery "ASMBS" include the following 1) adjustable gastric band, 2) sleeve gastrectomy, 3) gastric bypass, 4) biliopancreatic diversion, and 5) duodenal switch.
In general, there is a lack of long-term (5-10 years) and very long-term (> 10 years) outcome studies for modern bariatric surgery that would allow us to better define the role of each one of these procedures, especially after the advent of the laparoscopic approach.
In an animal model, diet induced obese animals exhibiting metabolic syndrome underwent Roux-en-Y gastric bypass with highly reproducible surgical outcomes as well as biochemical and energetic homeostatic abnormalities similar to post-RYGB findings in humans. Weight regain occurs in approximately 20% of patients after two to three years after RYGB. It seems that the weight-loss-promoting effects of chronically elevated plasma PYY concentrations dominate the weight-gain-promoting effects of lowered plasma leptin concentrations, with the relative plasma PYY: leptin concentration ratio determining whether weight loss will be sustained or regained.
Several studies have compared different Roux limb lengths in primary bariatric surgery. It seems to be that long limb RYGB (150cm), especially in patients with BMI > 50 kg/m2, confers at least better short-term weight loss without nutritional consequences. Conversely, other investigators have not found any clinically significant difference in weight loss with increasing Roux limb lengths, especially in patients with BMI < 50 kg/m2 23-26. The following are the main investigators that have increased the malabsorptive component of the failed proximal gastric bypass as a revisional strategy:
- Torres JC in 1991 was the first to propose this strategy with a cohort of 140 patients followed for 5 years (90.5% follow-up rate). Analyzed traditional outcome measures were early (2.1%) and late (27%) morbidity including protein-calorie malnutrition (7%); %EWL at 1,2,3,4,and 5 years were 89.5%, 91%, 87%, 82.5%, 82.5%, respectively; and re-operations.
- Fox SR and Oh KH et al in 1996 reported 10 failed proximal gastric bypass patients undergoing distal gastric bypass from an diverse group of failed primary surgeries (n=80) followed for 3 years with a 92.5% follow-up rate. Reported traditional outcome measures were early (39%) and late (84%) morbidity; %EWL at 1,2,\&3 years was 83%, 89%and 94%, respectively; high satisfaction was also reported.
- Sugerman et al in 1997 published their outcomes with 27 patients. Five patients were converted to a malabsortive distal gastric bypass with a 50cm common channel which required a second revision for malnutrition and two died. 22 patients were revised to a 150cm common channel; three patients required a second revision for malnutrition but %EWL went from 30% to 61% at 1 year and 69% at 5 years. They concluded that a 50cm common channel had an unacceptable morbidity and mortality.
- Fobi et al in 2000 presented his results of 65 patients after mostly failed primary Fobi pouch operation. 15 patients developed protein calorie malnutrition requiring supplemental nutrition and 6 required further revision.
- The 2001 Sapala´s et al partial outcome analysis on 303 varied revisionary micropouch gastric bypass procedures with a 200cm Roux limb, 150cm biliopancreatic limb and >200cm common channel. %EWL during 3 years is similar to the primary procedure (68.6%, 76.6%, and 72.3%). However no subset analysis is performed.
- Pareja et al analysis of 41 patients, undergoing diverse distal malabsorptive techniques, included 32 revisionary procedures after primary Fobi-Capella gastric bypass. At 11, 16, and 19 months of mean follow-up, %EWL for the Scopinaro-style, Brolin, and Fobi revisionary gastric bypasses were 69.7%, 65.0%, 74.8%, respectively. Failure and success rates according to Biron et al. are provided but no other subgroup analysis is provided.
- Brolin et al on 2007 reported 47 out of 54 patients undergoing revision for failed primary bariatric surgery had a very, very long limb gastric bypass with a 75cm to 100cm common channel and a 15cm to 25cm biliopancreatic limb. 7.4% (n=4) developed protein-calorie malnutrition from which one required 6 weeks of TPN, two elongation of the common channel (150cm) and one reversal after a prolonged hiatus returning with severe metabolic complications. 47.9% of the series lost at least 50% EWL at 1 year. There was no difference between those with primary failed restrictive vs. primary failed gastric bypass patients.
- Sarr et al on 2007 states that "patients with anatomically intact, non-malabsorptive RYGB when converted to a malabsortive distal RYGB, good results are not common".
To the best of our knowledge and after extensive literature search, there is no outcome study employing a laparoscopic approach for revisional malabsorptive distal Roux-en-Y gastric bypass specially increasing the restrictive component in a failed primary malabsorptive distal type of gastric bypass. Thus, we decided to analyze our own series including the learning curve and diverse revisional techniques in this unique subset of patients: 1) revision gastroplasty; 2) Fobi-Capella (static band); 3) Adjustable gastric band; 4) Conversion to either modality of malabsorptive distal gastric bypass, very, very long limb or distal.
Summarizing, there is lack of very-long term outcomes after bariatric surgery and standardization of gastric bypass surgery. The treatment of inadequate weight loss or weight recidivism after Roux-en-Y gastric bypass (RYGB) remains refractory to medical treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese and super obese, respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of procedure to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We analyze our experience with the laparoscopic approach to these complex and challenging patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malabsorptive distal gastric bypass | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients who met NIH criteria for recommendation of a bariatric procedure with the combination of the following characteristics:
Key exclusion criteria (2 listed)
- Patients with prior major conversions or revisions.
- Missing records and/or unreachable patients with scant information for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity and mortality
Time frame: throughout follow-up
Weight loss expressed as Body Mass Index and Percentage excess weight loss
Time frame: throughout follow-up
4 secondary outcomes
Traditional outcome measurements
Time frame: Variable
Remission or improvement of comorbidities
Time frame: throughout follow-up
Health-related Quality of Life (HR-QoL)
Time frame: at last follow-up
Subjective Satisfaction
Time frame: at the last follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
- Background: PubMed 10982506Higa KD, Boone KB, Ho T, Davies OG. Laparoscopic Roux-en-Y gastric bypass for morbid obesity: technique and preliminary results of our first 400 patients. Arch Surg. 2000 Sep;135(9):1029-33; discussion 1033-4. doi: 10.1001/archsurg.135.9.1029.
- Background: PubMed 15199035Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
- Background: PubMed 14644897McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, Lohr KN. Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Dec 2;139(11):933-49. doi: 10.7326/0003-4819-139-11-200312020-00013.
- Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Background: PubMed 15319713Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. doi: 10.1097/01.sla.0000137343.63376.19.
- Background: PubMed 17715409Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.
- Background: PubMed 17715408Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.
- Background: PubMed 18778174Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008 Sep;14(9):589-96.
- Background: PubMed 16234497Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. doi: 10.1001/jama.294.15.1909.
- Background: PubMed 17895461Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. doi: 10.1001/jama.298.12.1442. No abstract available.
- Background: PubMed 18725080Meguid MM, Glade MJ, Middleton FA. Weight regain after Roux-en-Y: a significant 20% complication related to PYY. Nutrition. 2008 Sep;24(9):832-42. doi: 10.1016/j.nut.2008.06.027.
- Background: PubMed 17828427Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. doi: 10.1007/s00464-007-9572-6. Epub 2007 Sep 8. No abstract available.
- "Click here for more information about the department sponsor´s web site"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Tercero, MD study director
Research Associate, University of California San Francisco
Kelvin D Higa, MD principal investigator
Professor of Surgery, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Severe Obesity and Obesity Recidivism, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity and mortality (time frame: throughout follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040481, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2009.