Internal HerniaIHafterLRYGBNCT01040364
Internal Hernias After Laparoscopic Gastric Bypass
An observational study of Internal Hernia and Mesocolic Hernia, run by University of California, San Francisco at 1 site in United States.
Trial summary
The main goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Internal Hernia, Mesocolic Hernia, Petersen´s Hernia
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 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 presenting with internal hernia after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB surgery from 1997-2009.
Who may be able to join
- patient status post primary laparoscopic standard RYGB surgery who underwent internal hernia reduction and repair with any or the combination of the following:
- closure of synchronous mesocolic or mesenteric space defects without incarcerated bowel
- conversion to open (laparotomy)
- small bowel resection with or without reversal
- status post primary laparoscopic standard RYGB surgery with incidental finding of internal hernia space defect with or without bowel through the defect
Who cannot join
- any other type of re-operative surgery after primary standard RYGB
- patient age < 18 years
- 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, Department of Surgery
Fresno, California, 93701
About this study
Official title: Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008
The main goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.
Read the detailed description
The main goal of this study is to describe and analyze the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB Surgery from 1997 to 2009.
Secondary study aims are to describe the following points 1. Clinical presentation, whether acute (small bowel obstruction), chronic (intermittent abdominal pain), or incidental finding -(asymptomatic); 2. Preoperative image studies. The percentage of patients that underwent preoperative CT/contrast studies as well as the percentage of patients that had positive, undetermined, and normal results; 3. Site of internal herniation including transverse mesocolon, jejunal mesentery, and Peterson's space as well as single vs. multiple internal hernias. This study along with the existing literature will allow us to formulate preliminary clinical recommendations.
This research is in line with the most current provocative new ideas and recent high impact publications. Most literature points towards the antecolic routing of the Roux limb to decrease the incidence rate of internal hernia formation. However, with this study we will demonstrate the statistically and clinically significant decrement of internal hernia formation with the improvement of the closure technique with a retrocolic antegastric routing of the Roux limb.
The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30 to 40 percent), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.
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 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percentage 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 surgery10. Along with the increasing number of elective primary weight loss procedures, up to 20 percent 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 reoperations 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.
There are no multi center, randomized, double blinded control trials comparing the different standard bariatric procedures. Gastric bypass is the oldest available bariatric procedure; without any randomized controlled trials, it is considered the gold standard procedure in the United States.
Incisional hernias occur at a higher incidence rate after open RYGB, approximately 20 percent, whereas after laparoscopic Roux-en-Y gastric bypass "RYGB", the incidence rate is very low. Conversely, Internal hernia is a rare complication with the open approach whereas after laparoscopic RYGB the incidence rate has been reported somewhere between 0.2 to 8.6 percent. The most accepted theory is due to decreased adhesion formation after laparoscopic surgery compared to open surgery.
Other factors associated with a higher incidence of internal hernia formation after RYGB are 1. childbearing age with the consequent pregnancy after RYGB, 2. Roux limb routing, 3. Closure of mesenteric and or mesocolic defects.
Although there have been no randomized controlled trials comparing different techniques of laparoscopic RYGB, several authors have report lower rates after modifying their technique from a retrocolic to an antecolic approach. On the other hand, others support meticulous defect closure as the most important factor in reducing hernia formation.
The method of fixation and mesenteric closure has evolved. Initially, as with the open approach, defects were not closed. Then, absorbable sutures were used which were changed for interrupted non-absorbable sutures. Lastly, continuous non-absorbable material for closing all defects was recommended by Sugerman.
Summarizing, there is no high level of evidence for recommending the best strategy to decrease the incidence rate the potentially devastating complication of internal hernia after laparoscopic RYGB. After reviewing the literature the trend is toward lower rates of internal hernia formation with antecolic compared to retrocolic, and with defect closure compared to nonclosure. There is great variation in the incidence rate among the reported series reflecting incomplete follow-up and other factors may affect outcomes. With this study, we will analyze the trends in the incidence rate of internal hernia formation among different subgroups in our consecutive series of more than 7,500 laparoscopic retrocolic RYGB with a hand-sawn gastrojejunostomy. With this consecutive series, we will confirm reports of small series that meticulous closure technique of mesocolic/mesenteric defects with continuous nonabsorbable material clinically and statistically decreases the formation rate of internal hernias after laparoscopic gastric bypass.
- Conditions
- Internal Hernia, Mesocolic Hernia, Petersen´s Hernia, Jejunojejunostomy Hernia, Bowel Obstruction, Ischemic Bowel
- Keywords
- Internal hernia, Mesocolic hernia, Petersen´s hernia, Jejunojejunostomy hernia, Bowel obstruction, Ischemic bowel, Complication after gastric bypass, Re-operative bariatric surgery, Chronic pain after gastric bypass
- Medical subject headings
- Internal Hernia, Intestinal Obstruction
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 |
|---|---|---|
| Interna hernia after primary gastric bypass | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure technique for mesocolic defect: 1- non-closure, 2- running with absorbable material, 3- interrupted with non-absorbable material, and 4- running with non-absorbable
Measured: throughout follow-up
recurrence of symptomatic mesocolic internal hernia
Measured: throughout 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 startMay 2009
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Internal HerniaStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- 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
- NCT01040364
- Sponsor's protocol ID
- CMC IRB No. 2009024
- Other IDs
- U1111-1113-0414
- Acronym
- IHafterLRYGB
- Status last verified
- Sep 2013
- First submitted
- 26 Dec 2009
- Last updated
- 24 Sep 2013
- 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 10982506McTigue 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 of Metabolic and Bariatric Surgeons.
Capella RF, Iannace VA, Capella JF. Bowel obstruction after open and laparoscopic gastric bypass surgery for morbid obesity. J Am Coll Surg. 2006 Sep;203(3):328-35. doi: 10.1016/j.jamcollsurg.2006.05.301. Epub 2006 Jul 27.
PubMed 16931305Champion JK, Williams M. Small bowel obstruction and internal hernias after laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2003 Aug;13(4):596-600. doi: 10.1381/096089203322190808.
PubMed 12935361Felsher J, Brodsky J, Brody F. Small bowel obstruction after laparoscopic Roux-en-Y gastric bypass. Surgery. 2003 Sep;134(3):501-5. doi: 10.1067/s0039-6060(03)00251-4.
PubMed 14555940
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008
- ClinicalTrials.gov ID
- NCT01040364
- Acronym / sponsor ID
- IHafterLRYGB / CMC IRB No. 2009024
- Conditions
- Internal Hernia, Mesocolic Hernia, Petersen´s Hernia, Jejunojejunostomy Hernia, Bowel Obstruction, Ischemic Bowel
- Keywords
- Internal hernia, Mesocolic hernia, Petersen´s hernia, Jejunojejunostomy hernia, Bowel obstruction, Ischemic bowel, Complication after gastric bypass, Re-operative bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 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 goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary laparoscopic Roux-en-Y gastric bypass (RYGB) surgery from 1997-2009.
Detailed description
The main goal of this study is to describe and analyze the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB Surgery from 1997 to 2009.
Secondary study aims are to describe the following points 1. Clinical presentation, whether acute (small bowel obstruction), chronic (intermittent abdominal pain), or incidental finding -(asymptomatic); 2. Preoperative image studies. The percentage of patients that underwent preoperative CT/contrast studies as well as the percentage of patients that had positive, undetermined, and normal results; 3. Site of internal herniation including transverse mesocolon, jejunal mesentery, and Peterson's space as well as single vs. multiple internal hernias. This study along with the existing literature will allow us to formulate preliminary clinical recommendations.
This research is in line with the most current provocative new ideas and recent high impact publications. Most literature points towards the antecolic routing of the Roux limb to decrease the incidence rate of internal hernia formation. However, with this study we will demonstrate the statistically and clinically significant decrement of internal hernia formation with the improvement of the closure technique with a retrocolic antegastric routing of the Roux limb.
The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30 to 40 percent), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.
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 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percentage 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 surgery10. Along with the increasing number of elective primary weight loss procedures, up to 20 percent 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 reoperations 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.
There are no multi center, randomized, double blinded control trials comparing the different standard bariatric procedures. Gastric bypass is the oldest available bariatric procedure; without any randomized controlled trials, it is considered the gold standard procedure in the United States.
Incisional hernias occur at a higher incidence rate after open RYGB, approximately 20 percent, whereas after laparoscopic Roux-en-Y gastric bypass "RYGB", the incidence rate is very low. Conversely, Internal hernia is a rare complication with the open approach whereas after laparoscopic RYGB the incidence rate has been reported somewhere between 0.2 to 8.6 percent. The most accepted theory is due to decreased adhesion formation after laparoscopic surgery compared to open surgery.
Other factors associated with a higher incidence of internal hernia formation after RYGB are 1. childbearing age with the consequent pregnancy after RYGB, 2. Roux limb routing, 3. Closure of mesenteric and or mesocolic defects.
Although there have been no randomized controlled trials comparing different techniques of laparoscopic RYGB, several authors have report lower rates after modifying their technique from a retrocolic to an antecolic approach. On the other hand, others support meticulous defect closure as the most important factor in reducing hernia formation.
The method of fixation and mesenteric closure has evolved. Initially, as with the open approach, defects were not closed. Then, absorbable sutures were used which were changed for interrupted non-absorbable sutures. Lastly, continuous non-absorbable material for closing all defects was recommended by Sugerman.
Summarizing, there is no high level of evidence for recommending the best strategy to decrease the incidence rate the potentially devastating complication of internal hernia after laparoscopic RYGB. After reviewing the literature the trend is toward lower rates of internal hernia formation with antecolic compared to retrocolic, and with defect closure compared to nonclosure. There is great variation in the incidence rate among the reported series reflecting incomplete follow-up and other factors may affect outcomes. With this study, we will analyze the trends in the incidence rate of internal hernia formation among different subgroups in our consecutive series of more than 7,500 laparoscopic retrocolic RYGB with a hand-sawn gastrojejunostomy. With this consecutive series, we will confirm reports of small series that meticulous closure technique of mesocolic/mesenteric defects with continuous nonabsorbable material clinically and statistically decreases the formation rate of internal hernias after laparoscopic gastric bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interna hernia after primary gastric bypass | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with internal hernia after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB surgery from 1997-2009.
Key inclusion criteria (5 listed)
- patient status post primary laparoscopic standard RYGB surgery who underwent internal hernia reduction and repair with any or the combination of the following:
- status post primary laparoscopic standard RYGB surgery with incidental finding of internal hernia space defect with or without bowel through the defect
Key exclusion criteria (3 listed)
- any other type of re-operative surgery after primary standard RYGB
- patient age < 18 years
- 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
Closure technique for mesocolic defect: 1- non-closure, 2- running with absorbable material, 3- interrupted with non-absorbable material, and 4- running with non-absorbable
Time frame: throughout follow-up
recurrence of symptomatic mesocolic internal hernia
Time frame: throughout 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 24 Sep 2013.
- 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 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.
- Backgroundhttp://www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgeons.
- "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 Internal Hernia and Mesocolic Hernia, 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 5 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 24 Sep 2013. 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?
Closure technique for mesocolic defect: 1- non-closure, 2- running with absorbable material, 3- interrupted with non-absorbable material, and 4- running with non-absorbable (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 NCT01040364, which also lists 26 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 24 Sep 2013.