Clinical trial NCT01040533: Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass
Official title: One-stage Laparoscopic Revision of Failed and/or Complicated Jejunoileal Bypass to Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinically Severe Obesity
Metabolic Complications After Jejunoileal Bypass
Nutritional Complications After Jejunoileal Bypass
Obesity Recidivism
Inadequate Initial Weight Loss
Intestinal Malabsorptive Syndrome
Protein Malnutrition
Keywords: Failed jejunoileal bypass
Complicated jejunoileal bypass
Revision gastric bypass
Revisional surgery
Reoperations
Metabolic and nutritional complications
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent laparoscopic revision of JIB to Roux-en-Y gastric bypass (RYGB) for poor weight loss or JIB-related late complications were analyzed. Failed or JIB-related late complications, mostly metabolic, were considered for surgical intervention after optimized medical multidisciplinary management

Brief summary: This study objectives are the following.

* To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB).
* To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss.
* To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.

Detailed description: 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 years8.

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 percent of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1 percent 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 percent of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.

Regardless of being an effective treatment of morbid obesity, JIB was abandoned in the early 80s mostly because of its metabolic and nutritional complications. Multiple patients who underwent this procedure more than two decades ago are still alive. Close follow-up, in even asymptomatic patients, is necessary after JIB because they may present with nonreversible complications.

As with any bariatric procedure, weight regain, inadequate initial weight loss, and late complications or a combination of them are the most widely accepted indications to undergo revisional bariatric surgery. Specifically, the JIB related late complications can be arbitrarily categorized into "malabsorption and malnutrition" and "bacterial overgrowth syndrome". The former might present with steatorrhea, electrolyte (K, Ca, P, Mg) and acid base imbalance (hyperchloremic metabolic acidosis), liposoluble (A, D, E, K) and hydrosoluble (B1, B12 and Folate) vitamin deficiencies, and protein calorie malnutrition "PCM". "The bacterial overgrowth syndrome" causes a variety of complications such as gas bloat syndrome, foul smelling flatulence, recurrent migratory polyarthralgia and necrotizing skin lesions. Other late non metabolic complications related to the bypassed bowel include intussusception, pseudo-obstruction, and bypass enteropathy.

"PCM" is quickly and effectively treated by parenteral nutritional support. Diet optimization with consumption of high biological value protein (90 g per day) and a total calorie intake adjusted to ideal body weight might decrease the severity of the malabsorption syndrome and or prevent its recurrence.

Transitory resolution of most symptoms caused by the bacterial overgrowth syndrome is accomplished by the administration, in divided doses, of oral tetracycline (2.0 g per day), amoxicillin-clavulanate (1 to 1.7g per day), clindamycin (0.9 to 1.8 g per day), and metronidazole (1 to 1.5 g per day) among others. Rapid symptomatic improvement is observed, however, over time, organisms become resistant to the systemic absorption of antibiotics, ceasing the benefit of this therapy. In addition, side effects including superinfections such as pseudomembranous colitis might present. Local instillation of antibiotic through an intestinal indwelling catheter placed in the excluded bowel limb has been described.

When the JIB related complications present as intractable, severe or recurrent, surgical intervention is required. Liver, either acute liver failure or cirrhosis, (secondary to "PCM" and bacterial overgrowth syndrome) and kidney, either tubulointerstitial nephropathy or renoureteral lithiasis, (secondary to enteric hyperoxaluria and volume depletion) dysfunction are the most frequently described complications leading to death. However, after end stage liver (cirrhosis) and renal diseases are established, good judgment is needed to assess the risk benefit algorithm for operative intervention, as these conditions are irreversible.

In the United States, the most popular type of intestinal bypass performed was the so called "14 plus 4" with an end to side jejunoileostomy, a 14 inches biliopancreatic limb with a 4 inches common channel. Because of poor weight loss, some surgeons used to performed an end to end jejunoileostomy avoiding chyme to reflux into the defunctionalized limb; Through an ileocolostomy, the defunctionalized jejunoileal limb was drained into the cecum or sigmoid colon.

Open reversal or conversion to gastric bypass has been shown to be effective procedures with defined complications. Since the 60s Payne, DeWind and Commons had already demonstrated that takedown and restitution of the gastrointestinal continuity is an effective strategy to solve the metabolic complications. However, relapse of obesity along with its comorbidities is the rule.

Series from the 70s and 80s suggested that one stage open revision of JIB to gastric bypass was feasible and safe. However, most of these revisions were performed a couple of years after the original bariatric surgery with a completely different configuration (non divided horizontal pouch with a loop gastrojejunostomy) from how modern RYGB is performed in these days. Hence, outcome analysis of those series is not transferable in today context.

Because of the long interval time between the JIB and the revision surgery, bowel adaptation is maximal causing a marked discrepancy in the lumen diameter and bowel thickness between the functional and defunctionalized bowel segments. Thus, different approaches have been described in the literature to deal with more extensive intestinal changes..

Based on Cannova et al. report in which described the placement of an intestinal indwelling catheter in the excluded bowel limb, Dallal et al. with a minimally invasive approach established enteral nutritional support in the defunctionalized bowel limb, to revert its atrophy. After a three month period with extensive counseling to undergo conversion to a RYGB, the patient decided just to be reversed.

Another staged option for revising the JIB is as follows. Initially, the JIB is dismantled and the normal gastrointestinal continuity restored. After the initially bypassed and atrophied small bowel regains its function and the bowel atrophy is partially overturned, the second stage (weight loss procedure) is performed, so weight loss can be maintained or achieved.

The two accepted revisionary procedures described in the literature for failed JIB are mainly adjustable gastric banding (AGB) and gastric bypass. In 2000, O'Brien et al. reported a series of 50 revisions to adjustable gastric banding. As the primary bariatric procedure, two patients had a JIB. A one stage open revision was performed without providing specific subset outcome analysis.

In 1993, Behrns et al. reported the outcome analysis of 61 open assorted revision surgeries from which 14 had a JIB. The indication for this subgroup was due to severe metabolic complications with a pre-revisional mean BMI of 34.2 kilograms per squared meter. Nine patients were revised to VBG and five patients to a non-divided, vertical RYGB. The percent excess weight loss for this five patients was 49.5 percent (overall follow-up was 23 months) with a 67 percent dissatisfaction rate of their new lifestyle because of the change in eating patterns caused by switching from a full size meal to a restricted diet.

In 1996, Owens et al. reported the open surgical revision of 75 patients from which 23 patients had a JIB as their primary procedure. Specific subgroup analysis was not provided. In 2005, khaitan et al. reported 37 patients who underwent 39 bariatric revisions, either open or laparoscopic. Originally, five had a JI bypass from which two were initially approached laparoscopically. However, specific subgroup analysis was not provided.

In summary, there are just two manuscripts reporting cases of attempted laparoscopic conversion of JIB to RYGB with its modern anatomical construction. However, a one stage procedure has not been achieved up to date. Therefore, no outcomes with this approach have been documented as well. With this study, we will advance our knowledge about revision bariatric surgery and report excellent outcomes after conversion from a completely malabsorptive procedure to a mostly restrictive weight loss procedure, the gastric bypass and although JIB was abandoned long time ago, there are still living patients with this procedure and bariatric surgeons need to be aware of side effects and minimally invasive strategies for the management of these highly complex patients.

Eligibility criteria: Inclusion Criteria:

* Met NIH criteria for weight loss surgery with poor weight loss after JIB
* Intractable, severe and/or recurrent JIB-related late complications after optimized medical management
* Laparoscopic approach for primary revisional bariatric surgery

Exclusion Criteria:

* Any other type of revisional bariatric procedure
* Open approach for revision surgery
* missing records and/or unreachable patients with scant information for analysis

Primary outcomes:
measure: Morbidity and mortality
timeFrame: throughout follow-up
measure: Weight loss expressed as Body Mass Index and Percentage excess weight loss
timeFrame: throughout follow-up
measure: Remission or improvement of symptoms and JIB-related complications
timeFrame: throughout follow-up
measure: Remission or improvement of other comorbidities
timeFrame: throughout follow-up
Secondary outcomes:
measure: Operative time
timeFrame: transoperatively
measure: conversion to open approach
timeFrame: transoperatively
measure: Hospital stay
timeFrame: same hospitalization
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno Center for Medical Education and Research, Department of Surgery
state: California
Study officials:
affiliation: Research Associate, University of California San Francisco
name: Francisco M Tercero, MD
role: STUDY_DIRECTOR
affiliation: Professor of Surgery, University of California San Francisco
name: Kelvin D Higa, MD
role: PRINCIPAL_INVESTIGATOR
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