Internal Hernias After Laparoscopic Gastric Bypass (IHafterLRYGB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040364
First received: December 26, 2009
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition
Internal Hernia
Mesocolic Hernia
Petersen´s Hernia
Jejunojejunostomy Hernia
Bowel Obstruction
Ischemic Bowel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Internal Hernias After Laparoscopic Roux-en-Y Gastric Bypass Over the Last Decade: 1997 to 2008

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • recurrence of symptomatic mesocolic internal hernia [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Interna hernia after primary gastric bypass

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with internal hernia after different modifications of the mesenteric closure technique after Primary Laparoscopic RYGB surgery from 1997-2009.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01040364

Locations
United States, California
UCSF Fresno Center for Medical Education and Research, Department of Surgery
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Director: Francisco M Tercero, MD Research Associate, University of California San Francisco
Principal Investigator: Kelvin D Higa, MD Professor of Surgery, University of California San Francisco
  More Information

Additional Information:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01040364     History of Changes
Other Study ID Numbers: CMC IRB No. 2009024, U1111-1113-0414
Study First Received: December 26, 2009
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
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

Additional relevant MeSH terms:
Hernia
Intestinal Obstruction
Ischemia
Hernia, Abdominal
Pathological Conditions, Anatomical
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014