Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass

Protein Malnutrition Clinical Trial

— JIB-to-RYGB  

Official title:

One-stage Laparoscopic Revision of Failed and/or Complicated Jejunoileal Bypass to Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040533
• Other study ID #: CMC IRB No. 2008085
• Secondary ID: U1111-1112-9885
• Status: Completed
• Phase: N/A
• First received: December 26, 2009
• Last updated: December 28, 2009
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Clinically Severe Obesity
• Inadequate Initial Weight Loss
• Intestinal Malabsorptive Syndrome
• Kwashiorkor
• Malnutrition
• Metabolic Complications After Jejunoileal Bypass
• Nutritional Complications After Jejunoileal Bypass
• Obesity
• Obesity Recidivism
• Obesity, Morbid
• Protein Malnutrition
• Weight Loss

Locations

Country	Name	City	State
United States	UCSF Fresno Center for Medical Education and Research, Department of Surgery	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (28)

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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. — View Citation

Behrns KE, Smith CD, Kelly KA, Sarr MG. Reoperative bariatric surgery. Lessons learned to improve patient selection and results. Ann Surg. 1993 Nov;218(5):646-53. — View Citation

Bradley JE, Brown RO, Luther RW. Multiple nutritional deficiencies and metabolic complications 20 years after jejunoileal bypass surgery. JPEN J Parenter Enteral Nutr. 1987 Sep-Oct;11(5):494-8. — View Citation

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. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation

Buckwalter JA, Herbst CA Jr. Reversal of jejunoileal bypass. Surg Gynecol Obstet. 1984 Oct;159(4):348-52. — View Citation

Cannova JV, Krummen DM, Schreiber H, Schaefer IK. An approach to the treatment of recurring polyarthralgia after jejunoileal bypass. Obes Surg. 1997 Jun;7(3):215-7; discussion 218-9. — View Citation

Charuzi I, Grizim D, Peiser J, Solomon H, Ovnat A. Simultaneous replacement of a failed jejunoileal bypass with a gastric bypass. Isr J Med Sci. 1984 Dec;20(12):1183-5. — View Citation

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. — View Citation

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Gasbarrini A, Lauritano EC, Gabrielli M, Scarpellini E, Lupascu A, Ojetti V, Gasbarrini G. Small intestinal bacterial overgrowth: diagnosis and treatment. Dig Dis. 2007;25(3):237-40. — View Citation

Griffen WO Jr, Hostetter JM, Bell RM, Bivins BA, Bannon C. Experiences with conversion of jejunoileal bypass to gastric bypass: its use for maintenance of weight loss. Arch Surg. 1981 Mar;116(3):320-4. — View Citation

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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. — View Citation

Khaitan L, Van Sickle K, Gonzalez R, Lin E, Ramshaw B, Smith CD. Laparoscopic revision of bariatric procedures: is it feasible? Am Surg. 2005 Jan;71(1):6-10; discussion 10-2. — View Citation

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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. Review. — View Citation

Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. Epub 2007 Sep 8. — View Citation

O'Brien P, Brown W, Dixon J. Revisional surgery for morbid obesity--conversion to the Lap-Band system. Obes Surg. 2000 Dec;10(6):557-63. — View Citation

Pessa M, Robertson J, Woodward ER. Surgical management of the failed jejunoileal bypass. Am J Surg. 1986 Mar;151(3):364-7. — View Citation

Raftopoulos I, Courcoulas AP. Revision of jejunoileal bypass to Roux-en-Y gastric bypass: technical considerations and outcomes from 2 cases. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):198-201. Epub 2007 Dec 11. — View Citation

Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. — View Citation

Sjöström L, Narbro K, Sjöström 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, Lönroth H, Näslund I, Olbers T, Stenlöf 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. — View Citation

Tapper D, Hunt TK, Allen RC, Campbell J. Conversion of jejunoileal bypass to gastric bypass to maintain weight loss. Surg Gynecol Obstet. 1978 Sep;147(3):353-7. — View Citation

Wands JR, LaMont JT, Mann E, Isselbacher KJ. Arthritis associated with intestinal-bypass procedure for morbid obesity. Complement activation and characterization of circulating cryoproteins. N Engl J Med. 1976 Jan 15;294(3):121-4. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity and mortality		throughout follow-up	Yes
Primary	Weight loss expressed as Body Mass Index and Percentage excess weight loss		throughout follow-up	No
Primary	Remission or improvement of symptoms and JIB-related complications		throughout follow-up	No
Primary	Remission or improvement of other comorbidities		throughout follow-up	No
Secondary	Operative time		transoperatively	No
Secondary	conversion to open approach		transoperatively	No
Secondary	Hospital stay		same hospitalization	No

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