AzTrials
AzTrials

Clinically Severe ObesityVBGNCT01041131

Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass

An observational study of Clinically Severe Obesity and Inadequate Weight Loss, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
70 participants
Where
1 siteUnited States
Study dates
Oct 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 status post failed and/or complicated Vertical Banded Gastroplasty (VBG) undergoing conversion to laparoscopic Roux-en-Y gastric bypass (RYGB)

Who may be able to join

  • Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB

Who cannot join

  • Patients with prior major conversion, revision, and/or esophago-gastric surgery
  • Conversion performed by open approach
  • Conversion performed somewhere else with follow-up by our program

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSF Fresno Center for Medical Education and Research

    Fresno, California, 93701

Other trials in United States

About this study

Official title: Laparoscopic Revisional Gastric Bypass Surgery for Failed and/or Complicated Open Vertical Banded Gastroplasty: Our Experience With 70 Patients

The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). 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. 3) Subjective Satisfaction and Health-Related Quality of Life "HR-QoL" are measured by a standardized, non-validated satisfaction questionnaire and by a validated, disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity \& Mortality include nutritional status and metabolic complications.

Consequently, secondary objectives of this study are the following. 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 assessed at each postoperative year after the surgery under study. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.

Read the detailed description

There is no real standardization for any of the previously stated "modern standard bariatric procedures" endorse by the ASMBS; thus, outcomes vary widely with each one of them. For purposes of this study, the term Vertical Banded Gastroplasty (VBG) is used to encompass several types of vertical gastroplasties with a reinforced stoma such as nondivided vertical banded gastroplasty, nondivided vertical ringed gastroplasty, transected or divided vertical ringed or banded gastroplasties among others. VBG, in various forms, was used extensively for more than 2 decades after its original description by Mason in 198217. Designed to avoid the long-term nutritional implications and complexity of gastric bypass, VBG evolved and permitted us to infer some mechanism of failure and modify other bariatric procedures. Regardless of a laparoscopic approach, VBG is no longer a viable option for the treatment of morbid obesity because of less overall weight loss, high failure and late complication rates.

The following are the main investigators that have addressed diverse revisional strategies including restoration or conversion of VBG into a modern bariatric procedure, either by open or laparoscopic approach, because of failure and/or technical complications:

  1. Open approach. Most of the scientific literature available on redo bariatric surgery is based on open surgery series. There is no consensus on what type of revisional procedure is the best; however, there are several options available.
  2. Restoration or re-VBG is no longer a viable option.
  3. In a study of 122 gastroplasties, Sugerman et al reported that four out of ten re-VBG patients required a third revision.
  4. With a Kaplan-Meyer analysis, Van Gemert et al found that re-VBG carry a secondary revisional rate of 68% over a 5-year period vs. a 0% rate after conversion to RYGB.
  5. Other revisional option is adjustable gastric band (AGB).
  6. In 2001, Charuzi et al described revisional adjustable gastric band after diverse failed primary bariatric procedures. However, they reported their compound outcome results without subset analysis.
  7. In the same year, Taskin et al published a series of 7 patients undergoing revisional adjustable gastric banding and obtained comparable results with primary AGB at 2 years. However, all patients had preoperatively identified a staple-line failure and the morbi-mortality was not stated.
  8. In 2004, Gavert et al analyzed 47 patients undergoing laparoscopic revisional surgery using AGB with a mean BMI at 16 months of 32 and an early complication rate of 4%. No mortality was reported.
  9. Other recently added strategy to the revisional armamentarium is Sleeve Gastrectomy (SG). Iannelli et al in 2009 published the analysis of 41 patients undergoing revisional SG for failed AGB (n=36) or VBG (n=5). No subset analysis was provided however postoperative morbidity was 12.2%; at a mean of 13.4 months, mean BMI, %EWL, and %EBL were 42.7%, 42.7%, 47.4% respectively; and re-operation rate for failure was 14.6% (n=6).
  10. Another reported revisional procedure is Biliopancreatic Diversion with Duodenal Switch (BPD-DS).
  11. Of 47 patients revised to BPD-DS by Keshishian et al, 16 had a VBG as the primary bariatric procedure. Their reported outcome data is mixed with failed RYGB (n=31). Although this revisional strategy carried a higher major morbidity rate (12.8%), the weight loss was comparable to the primary BPD-DS.
  12. However, most published studies about revisional surgery for failed or complicated VBG support RYGB as a revisional procedure. Previously some investigators have shown the RYGB superiority over VBG. Specifically, RYGB has more overall weight loss, less late complications and less revision rates than VBG.
  13. Sugerman and van Gemert have compared restoration vs. conversion to RYGB, highlighting again the supremacy of RYGB, mostly based on the revisional rate and weight loss. Therefore, conversion of VBG to RYGB seems to be logical.
  14. In 1993, Sapala et al (n=20) reported technical strategies for converting VBG to RYGB. Major early morbidity occurred in 4 patients (20%).
  15. In 1996, Sugerman et al (n=53) obtained a statistical significant increased of %EWL from 36% to 67% and 20% to 70% in "big eaters" and in "sweets eaters", respectively. Weight loss for revisional RYGB was comparable to the one after primary RYGB. Upper GI symptoms were completely resolved. Morbidity was described in 26 patients (49%).
  16. In 1998, Capella \& Capella (n=60), with an adjusted Roux-limb length for BMI, reported at 1 year follow-up 68% and 76% EWL for proximal and distal RYGB patients, respectively.
  17. In 2004, Cordera et al (n=54), with an adjusted Roux-limb length for BMI, reported weight loss as a decrease in BMI from 46 Kg/m2, at the time of conversion, to 35 Kg/m2 at 6.1 years (94% patients). In addition, comorbidities status measured by medication consumption were ameliorated and subjective patient satisfaction at survey was high (90%). However, one year post-conversion 41% of the series had a BMI greater than 35 Kg/m2.
  18. In 2005, Gonzalez et al (n=28), on a 5 basic steps of standardized technique and adjusted Roux-limb length for BMI, reported a decrease in BMI from 40 Kg/m2 to 32 Kg/m2 at 16 months of follow-up. Overall %EWL was 48% (range, 3-71%), however, resolution in comorbidities ranged from 50 to 86%. Early morbidity occurred in 9 patients (32%).
  19. In 2007, van Dielen et al (n=41) revised 11 AGB and 30 VBG most of them by open approach. BMI decreased from 37.7 to 29.4 at 12 months while %EWL increased from 39.1% to 75.4% (p< 0.001). Major early (n=4) and late (n=10) complications were registered. No remission in comorbidities was observed35.
  20. In the 2007 outcome analysis by Schouten et al (n=101) found out that the effect on weight is dependent of the indication for revision. Weight recidivism patient's BMI decreased from 40.5 Kg/m2 to 30.1 Kg/m2; excessive weight loss patients BMI increased from 22.3 Kg/m2 to 25.3 Kg/m2; and adequate response patients to VBG but with severe eating difficulties remained stable (29.8 Kg/m2 to 29.0 Kg/m2) all after a mean follow-up of 38 months.

Therefore, based on all this observational studies, the open conversion of VBG to RYGB has been demonstrated to be an effective procedure with defined complications.

II. Laparoscopic Approach. Increasing experience with minimally invasive bariatric surgery has prompted surgeons to approach most revisions procedures laparoscopically.

  1. Because most published studies about open revisional surgery for failed and/or complicated VBG support RYGB as the revisional procedure of choice, most laparoscopic bariatric surgeons follow this principle.
  2. Csepel et al (n=7), in 2001, reported their initial experience with laparoscopic approach for revision bariatric surgery; 6 patients in this group had failed VBG. Pre-revisional BMI decreased from 42.2 to 37.2 without specifying the length of follow-up or resolution of comorbidities. Three major complications (42.8%) were reported.
  3. Gagner et al reported their continued revisional experience with 12 patients, a subgroup of 27, who underwent reoperation for failed VBG. Overall, pre-revisional BMI decreased from 42.7 Kg/m2 to 35.9 Kg/m2 after 8 months of follow-up (p< 0.001) with a 22% complication rate. Resolution of comorbidities was not stated.
  4. Gagne et al, in 2005, reported their experience revising laparoscopically 25 patients with a 24% morbidity rate, 51 %EWL at 3 years, 100% resolution of diabetes and 63% resolution of hypertension.
  5. In 2005, Calmes et al (n=49) reported their initial experience with laparoscopic revisional RYGB with 15 patients, a subset of 49, who had a failed or complicated VBG. Overall complication rate of 36% (Major 4%, minor 20% and late 14%) 70-75% of the patients at 4 years had a BMI less than 35.
  6. In 2007, Suter et al reported their accumulative experience with open (n=47) and laparoscopic (n=74) revisional RYGB. The primary procedures were LAGB (n=82), VBG (36) and RYGB (n=3). Overall morbidity was 26.4% and 75% of the patients at 5 years had a BMI less than 35 Kg/m2.
  7. Van Dessel et al, in 2008, published his experience on 36 patients with laparoscopic revisional RYGB for failed restrictive procedures ( 14 VBG, 20 AGB, and 2 SG). After a short follow-up of 6.6 months, early and late morbidity was 30% and 16.7%, respectively; BMI dropped from 38.8 kg/m2 to 30.9 kg/m2; and a higher but not significant early morbidity rate for the complicated vs. the failed subgroups

Summarizing, there is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure and secondary revisional rates after VBG can be as high as 56% and 68%, respectively. Indication for further surgical intervention remains controversial, as does what type of procedure to recommend but the most widely documented and with best risk-benefit ratio option is RYGB. After extensive literature search, there is no outcome study employing a laparoscopic revisional strategy with a HSA reporting outcomes comparable to primary gastric bypass in an unselected obese population. Thus, we formally analyze our experience with the laparoscopic approach to these complex and challenging patients.

Keywords
Obesity, Obesity recidivism, Inadequate Initial Weight Loss, Technical bariatric complications, Complicated gastroplasty, Failed gastroplasty, Gastroesophageal reflux disease, Revisional gastric bypass, Conversion bariatric surgery, Re-operative bariatric surgery, Technical complications of vertical gastroplasty, Complicated vertical gastroplasty
Medical subject headings
Obesity, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01041131
Study groupRoleWhat they receive
Failed and/or Complicated VBGNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity and mortality

    Measured: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years

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

    Measured: at 6 months, 1 year and annually thereafter for up to 8 years

  3. Remission or improvement of symptoms

    Measured: at 6 months, 1 year and annually thereafter for up to 8 years

Secondary outcomes (3)
  1. Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision

    Measured: It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study

  2. Remission or improvement of comorbidities

    Measured: at 6 months, 1 year, and annually thereafter for up to 8 years

  3. Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome.

    Measured: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041131
Sponsor's protocol ID
CMC IRB No. 2009073
Other IDs
U1111-1113-0085
Acronym
VBG
Status last verified
Dec 2009
First submitted
26 Dec 2009
Last updated
1 Jan 2010
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 10982506
  • Hedley 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 15199035
  • Buchwald 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 15479938
  • Christou 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 15319713
  • Adams 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 17715409
  • Sjostrom 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 17715408
  • Cremieux 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 18778174
  • Santry 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 16234497
  • Flum 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 17895461
  • Meguid 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 18725080
  • Nguyen 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 17828427
  • ASMBS www.asbs.org/htm/Private/resolution.html

  • 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 16901357
  • Pories 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
  • Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.

    PubMed 17060766

Questions about this trial

What is this clinical trial studying?

An observational study of Clinically Severe Obesity and Inadequate Weight Loss, 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 1 inclusion and 3 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 1 Jan 2010. 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: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years). The study lists 3 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 NCT01041131, which also lists 40 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 1 Jan 2010.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in