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Laparoscopic gastric plication versus mini-gastric bypass surgery in the treatment of morbid obesity: a randomized clinical trial

Article in Press

Laparoscopic gastric plication versus mini-gastric bypass surgery in the treatment of morbid obesity: a randomized clinical trial

Received 18 December 2012; accepted 20 July 2013. published online 26 July 2013.

Abstract

Background

Laparoscopic gastric plication (LGP) is emerging as a safe and effective bariatric procedure. However, there are no reports on the comparison between the efficacy and complications of LGP and laparoscopic mini-gastric bypass (LMGB), which is still an investigational bariatric procedure. The objective of this study was to compare safety and efficacy of LGP and LMGB in the treatment of morbid obesity in a one-year follow-up study.

Methods

Forty patients met the National Institutes of Health criteria and were randomly assigned to receive either LGP (n = 20) or LMGB (n = 20) by a block randomization method. Early and late complications, body mass index (BMI), excess weight loss, and obesity-related co-morbidities were determined at the 1-year follow-up.

Results

Operative time and mean length of hospitalization were shorter in the LGP group (71.0 minutes versus 125.0 minutes,P<.001, and 1.6 days versus 5.2 days; P<.001, respectively). The mean percentage of excess weight loss (%EWL) at 12 months follow-up was 66.9% in the LMGB group and 60.8% in the LGP group (P = .34). Improvement was observed in all co-morbidities in both groups, with the exception of hyperlipidemia, which remained unresolved in 4 patients. Lower incidence of iron deficiency occurred in the LGP group (P = .035). Rehospitalization and reoperation were not required in any cases. Considering the cost of instruments used in the LMGB procedure and operative time, LGP saved approximately $2,500 per case compared with LMGB.

Conclusions

Both LGP and LMGB are effective weight loss procedures. LGP proved to be a simpler and less costly procedure compared with LMGB with a lower risk of iron deficiency during a 1-year follow-up study.

Keywords: Morbid obesityBariatric surgeryLaparoscopyMini-gastric bypassGastric plication

Laparoscopic Roux-en-Y Versus Mini-Gastric Bypass for the Treatment of Morbid Obesity

Ann Surg. 2005 July; 242(1): 20–28.
PMCID: PMC1357700

Laparoscopic Roux-en-Y Versus Mini-Gastric Bypass for the Treatment of Morbid Obesity

A Prospective Randomized Controlled Clinical Trial
Wei-Jei Lee, MD, PhD,* Po-Jui Yu, RN,† Weu Wang, MD,* Tai-Chi Chen, MD,* Po-Li Wei, MD,* and Ming-Te Huang, MD*
This article has been cited by other articles in PMC.

Abstract

Objectives:

This prospective, randomized trial compared the safety and effectiveness of laparoscopic Roux-en-Y gastric bypass (LRYGBP) and laparoscopic mini-gastric bypass (LMGBP) in the treatment of morbid obesity.

Summary Background Data:

LRYGBP has been the gold standard for the treatment of morbid obesity. While LMGBP has been reported to be a simple and effective treatment, data from a randomized trial are lacking.

Methods:

Eighty patients who met the NIH criteria were recruited and randomized to receive either LRYGBP (n= 40) or LMGBP (n = 40). The minimum postoperative follow-up was 2 years (mean, 31.3 months). Perioperative data were assessed. Late complication, excess weight loss, BMI, quality of life, and comorbidities were determined. Changes in quality of life were assessed using the Gastro-Intestinal Quality of Life Index (GIQLI).

Results:

There was one conversion (2.5%) in the LRYGBP group. Operation time was shorter in LMGBP group (205 versus 148, P < 0.05). There was no mortality in each group. The operative morbidity rate was higher in the LRYGBP group (20% versus 7.5%, P < 0.05). The late complications rate was the same in the 2 groups (7.5%) with no reoperation. The percentage of excess weight loss was 58.7% and 60.0% at 1 and 2 years, respectively, in the LPYGBP group, and 64.9% and 64.4% in the LMGBP group. The residual excess weight <50% at 2 years postoperatively was achieved in 75% of patients in the LRYGBP group and 95% in the LMGBP group (P < 0.05). A significant improvement of obesity-related clinical parameters and complete resolution of metabolic syndrome in both groups were noted. Both gastrointestinal quality of life increased significantly without any significant difference between the groups.

Conclusion:

 Both LRYGBP and LMGBP are effective for morbid obesity with similar results for resolution of metabolic syndrome and improvement of quality of life. LMGBP is a simpler and safer procedure that has no disadvantage compared with LRYGBP at 2 years of follow-up.

My Lap-Band disaster; BY RAYYA ELIAS

http://www.salon.com/2013/07/08/my_lap_band_disaster/

MONDAY, JUL 8, 2013 04:30 PM PDT

My Lap-Band disaster

Doctors said I wasn’t fat enough for weight-loss surgery. But I got it done anyway — and suffered the consequences

BY 

TOPICS: BODY WARSLIFE STORIESLAP BANDWEIGHT LOSSADDICTIONEDITOR’S PICKS

My Lap-Band disaster

I tipped the scales at 206 pounds, and I was miserable. I needed to get healthy, but that was easier said than done. I loved sweets, and soda, and pasta, and everything that would put me into a food coma so I didn’t have to feel my feelings.

I was six years clean after a long, catastrophic addiction to heroin and cocaine. In the past I used drugs to lose weight; this time, my only option was to eat better. I had spent many therapy sessions exploring the reasons for my overeating, but they were feeling like excuses. If I wanted to drop those pounds, I’d have to do what everyone else did: put in the work. I’d watched Oprah. I knew I wasn’t alone.

I hired a trainer and worked my ass off at the gym three times a week. I started doing yoga and signed up for the food delivery service that all the stars supposedly used. After the first 25 pounds, I switched over to Weight Watchers, and it all worked: I lost 50 pounds. I felt like a champ. And that’s where I stayed for three years—until one day, I pulled a hamstring during a Vinyasa class.

That was the beginning of the end. The muscle was constantly irritated and inflamed, no matter what I did. Doctors prescribed physical therapy, but it didn’t help (nor did my insurance cover it). I tried to go back to the gym, but the pain was intolerable. My wonderful workout regime was slipping away from me. Depressed and angry, I turned back to my available anesthetic: food. The weight came back.

One day my friend Shawn mentioned someone with a weight problem who had a band put in.

“What’s that?” I asked.

“A Lap-Band,” he said. “You know, the alternative to the hardcore stomach surgery?”

That was all he had to say. I beat an obsessive track to Google and looked up everything I could about Lap-Band surgery, which I now saw as the answer I’d been looking for. I was back in the 175-pound range, and panicked that I might end up where I’d been a few years earlier. But there was one problem: I was too thin for a Lap-Band, and I didn’t have a high enough body mass index. I called everywhere in New York — no luck.

I wouldn’t be so easily deterred. This was the answer, damn it! I wanted to be happy and get on with my life and finally love myself because I’d be thin. So instead of listening to the professionals, I plowed ahead with my search. No one was gonna tell me I wasn’t fat enough to get skinny.



I spoke to doctors in London, and they referred me to Dr. Favretty, the guy who invented this surgery. He was Italian, and he and his partner traveled to England twice a month to perform the procedure. Favretty was having success with low-BMI people like me. For $14,000, I could have the surgery. I spoke to my partner about it, and she agreed it was the answer. A month later — off I went.

The surgery took place in Manchester. When I walked into the waiting room, I noticed that everyone was morbidly obese. They were looking at me as if I’d already had the operation. While the nurses and staff were prepping me for surgery, they shared their own stories of Lap-Band success, which eased my tension, but I was still nervous. Hello! I was in a foreign country, by myself, having surgery!

I woke up with five incisions in my stomach and a lot of pain. The next day I was released and given a strict diet: protein drinks for the next four to six weeks, then mushy food, and after eight weeks I had to come back to England to get the Lap-Band filled in order to restrict the size of my stomach. When I got back to my hotel, the pain was so bad I was hardly able to move. I took the prescribed pain medication, but when I started having the urge to smoke cigarettes and watch porn, I threw it out. That was the first sign of my addiction sticking its tongue in my ear.

When I went back home, my partner and I made a secrecy pact: No one would ever know about the surgery. I was so ashamed at “taking the easy way out” (or so I thought) that I lied about why I was in England. I told tales about going there for work and pitching my new script to a production company. It sounded glamorous, and because of my lifestyle (writer/director of two films) no one questioned me. But I was embarrassed by the lengths I’d gone to to spin this tale. It’s the secrets that keep you sick.

For the next four weeks, I was on a liquid diet and lost about 10 pounds. Because our social life revolved around food, I told people I’d had oral surgery and couldn’t chew anything. I drank everything and food processed everything else. In retrospect, if I had just done that liquid diet I would’ve lost the same amount of weight. Still, I felt good and was looking like the girl I’d been about a year earlier.

When I moved to solid foods, however, the situation got tricky. All the things I liked — all the things I could keep down — were high-calorie foods. Ice cream, and cookies soaked in tea, and bisque, and mashed potatoes. It was hard for me to eat any protein, let alone vegetables. Every time I tried to eat broccoli or carrots or anything healthy I used to enjoy, it would get caught in my throat and hurt so badly that I would race to the bathroom to puke.

This wasn’t good for my body, but it was especially bad for my mind. The surgery should have simplified my relationship to food; instead I thought about it 24/7. I questioned everything I had ever learned about positive eating habits. At the hospital I’d been told not to eat in the morning.Huh? I thought that was the most important meal of the day? Not when you have a Lap-Band, as it turns out. It’s at its tightest in the morning so you can’t put anything in without having it come back up. It had taken me 46 years to learn the rules of healthy living, and now I’d gone and changed them. What had I done?

Between weeks six and eight I put all the weight back on that I’d lost, plus a few extra pounds. I was beside myself with fear, shame and guilt, all while still keeping the surgery a secret. I went back to Manchester to see the doctors and have my first band adjustment, which means they fill the thing with saline to limit food intake into your stomach, which basically means anything that doesn’t fit through the little hole backs up into your throat and you either puke it up or choke on it. Even water has a hard time getting through.

I tried to ask all the right questions and even went to a support meeting at the hospital. Go with it, I kept telling myself, it’s helping all these other people, surely it will help me! But nothing eased the fear that I’d made a huge mistake. They gave me my first adjustment, put me on another liquid diet, and sent me on my way. Back to New York I went with a referral for aftercare and future adjustments.

On my return, I gained even more weight. Frustrated and at a loss, I went to the NYU Bariatric Center, where I met with my aftercare doctor. He himself had had the Lap-Band procedure done and was very optimistic that it would work for me. He said the band needed more fluid in order to work for me. You see, what I eventually found out is that the surgery works for the morbidly obese because no matter how high their calorie intake with the Lap-Band, it’s still less than they’re used to having. As for me, prior to the surgery I ate very healthy, just too much; but the surgery no longer allowed me to eat those healthy foods — like chicken, grains and broccoli — because they were too high in fiber to go down. Instead, I turned to pudding and macaroni — so of course I gained weight.

After the doctor put more fluid in the band, I could hardly breathe, much less eat or drink. I had to go back and have it let out again. The doctor kept telling me there was a comfort zone, a sweet spot, but after at least 15 trips to the clinic and months of not being able to lie down flat in my bed and sleep because my own saliva would choke me, I’d had enough. I had hit rock bottom with this thing: I weighed over 185 pounds, couldn’t sleep, couldn’t eat the things I liked and my body needed, and was so depressed that I had to go see my old shrink and get back on antidepressants.

I could get sober, but I couldn’t conquer this? I had to give up the hope of a quick fix: I mean, if you could pay to be thin, wouldn’t all rich people do it? But I knew the weight, like the drugs, was an inside job.

I kept talking to my therapist about why I felt the need to keep this secret. I mean, I’m a recovering drug addict who used to shoot cocaine and heroin intravenously and I’m not ashamed of that — how could I be so ashamed of this? Where did this self-loathing come from? I really needed to get to the bottom of these feelings. At the same time, I was taking a more pragmatic approach to the band. I joined Weight Watchers again. I had started utilizing it in a way that I was comfortable with, working around its limitations. When I made the decision not to be a victim of the Lap-Band but to take control, things got much better. I got much better. Now, I’ve learned to use all the tools that are at my disposal. I’m a steady 155 pounds, give or take a few (which I don’t fret about anymore). The band has definitely helped me, and gentle forms of exercise have kept me healthy.

I took a chance and told my sister about the surgery that summer. She didn’t judge me, and neither did the people I told afterward. In fact, the more I discussed it, the more I was able to accept it as well.

If I had to do it all over again, would I still spend my money on this? Probably, because my obsession with my weight and body image are much deeper than the money, and I feel great in my skin right now. But when I finally opened up about my struggles — that’s when I felt the real weight lift.

Rayya Elias was born in Aleppo Syria in 1960. Her family moved to Detroit in late 1967. She is an author, musician, and filmmaker. Her book “Harley Loco: A Memoir of Hard Living, Hair, and Post Punk, from the Middle East to the Lower East Side” was published by Viking in April 2013. She has a Huffington Post blog. She lives in New  York City.MORE RAYYA ELIAS.

From Mindless to Mindful Practice — Cognitive Bias and Clinical Decision Making Pat Croskerry, M.D., Ph.D. N Engl J Med 2013; 368:2445-2448June 27, 2013

Perspective

From Mindless to Mindful Practice — Cognitive Bias and Clinical Decision Making

Pat Croskerry, M.D., Ph.D.

N Engl J Med 2013; 368:2445-2448June 27, 2013DOI: 10.1056/NEJMp1303712

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Audio Interview

Interview with Dr. Pat Croskerry on widespread cognitive biases and ways of counteracting them for accurate diagnosis.

Interview with Dr. Pat Croskerry on widespread cognitive biases and ways of counteracting them for accurate diagnosis. (17:18)

The two major products of clinical decision making are diagnoses and treatment plans. If the first is correct, the second has a greater chance of being correct too. Surprisingly, we don’t make correct diagnoses as often as we think: the diagnostic failure rate is estimated to be 10 to 15%. The rate is highest among specialties in which patients are diagnostically undifferentiated, such as emergency medicine, family medicine, and internal medicine. Error in the visual specialties, such as radiology and pathology, is considerably lower, probably around 2%.1

Diagnostic error has multiple causes, but principal among them are cognitive errors. Usually, it’s not a lack of knowledge that leads to failure, but problems with the clinician’s thinking. Esoteric diagnoses are occasionally missed, but common illnesses are commonly misdiagnosed. For example, physicians know the pathophysiology of pulmonary embolus in excruciating detail, yet because its signs and symptoms are notoriously variable and overlap with those of numerous other diseases, this important diagnosis was missed a staggering 55% of the time in a series of fatal cases.2

Over the past 40 years, work by cognitive psychologists and others has pointed to the human mind’s vulnerability to cognitive biases, logical fallacies, false assumptions, and other reasoning failures. It seems that much of our everyday thinking is flawed, and clinicians are not immune to the problem (see Clinical Examples of Cognitive Failure). More than 100 biases affecting clinical decision making have been described, and many medical disciplines now acknowledge their pervasive influence on our thinking.

Cognitive failures are best understood in the context of how our brains manage and process information. The two principal modes, automatic and controlled, are colloquially referred to as “intuitive” and “analytic”; psychologists know them as Type 1 and Type 2 processes. Various conceptualizations of the reasoning process have been proposed, but most can be incorporated into this dual-process system. This system is more than a model: it is accepted that the two processes involve different cortical mechanisms with associated neurophysiologic and neuroanatomical substrates. Functional magnetic resonance imaging scans vividly reveal the changes in neuronal activity patterns as processes move from one system to the other during learning. Although the two processes are often construed as two different ways of reasoning, in fact very little (if any) reasoning occurs in Type 1 processing — it is largely reflexive and autonomous. The Augenblick diagnosis, made in the blink of an eye, is an impressive piece of medical showmanship and the stuff of television entertainment (and corridor consultations), but in real clinical life it is fraught with danger.

Descriptions of the operating characteristics of the dual processing system in clinical reasoning provide a useful starting point for learning about medical decision making.3 Intuitive processes are generally either hard-wired or acquired through repeated experience. They are subconscious and fast and mostly serve us well, enabling us to conduct much of our daily business in all fields of human activity. We mostly get through life by moving from one of the intuitive mode’s associations to the next in a succession of largely mindless, fixed-action patterns. These patterns are indispensable; however, they are also the primary source of cognitive failure. Most biases, fallacies, and thinking failures arise from the intuitive mode (see box). When primary care physicians trust their intuition that a patient’s chest pain does not have a cardiac origin, they will usually be correct — but not always. The clinical gamble of trusting one’s intuitions generally carries good odds, but inevitably those intuitions will fail some patients. The issue is whether we can tolerate the current levels of failure — or is there room for improvement?

Analytic processes, by contrast, are conscious, deliberate, slower, and generally reliable. They follow the laws of science and logic and therefore are more likely to be rational. Despite the ubiquity and usefulness of intuitions, they are not reliable enough for us to use them to send a spaceship to Mars. By contrast, when a patient undergoes analytic assessment for chest pain in a cardiac clinic that culminates in angiography, the conclusion is invariably correct. Analytic failures can occur, but usually when the wrong rules are followed or other factors come into play, such as cognitive overload, fatigue, sleep deprivation, or emotional perturbations. The biggest downside of analytic reasoning is that it’s resource-intensive. Although analytic reasoning can often be done quickly and effectively, in most fields of medicine, it would be impractical to deal with each clinical decision analytically.

Given the substantial impact of our evolving understanding of cognition over the past few decades, it is somewhat surprising that these major social science findings have not readily made their way into medicine. Although our awareness of research biases led to the development of the randomized, prospective, double-blind clinical trial, we remain unrealistic about the scale of everyday cognitive and affective biases and their effect on clinical reasoning. Cognitive psychology has not historically been considered within the remit of medicine, but I believe that we should embrace any work that helps us think about our thinking (metacognition) and that it would be beneficial both to include basic psychology courses in the medical school curriculum and to expand medicine’s lexicon to incorporate terms from cognitive psychology.

If cognitive biases are so abundant and troublesome in clinical decision making, why not simply identify them and use a “debiasing” strategy to avoid them? Unfortunately, that’s not as easy as it sounds. First, many decision makers are unaware of their biases, in part because our psychological defense mechanisms prevent us from examining our thinking, motivation, and desires too closely. Second, many clinicians are unaware of, or simply don’t appreciate the effect of, such influences on their decision making.

Becoming alert to the influence of bias requires maintaining keen vigilance and mindfulness of one’s own thinking. When a bias is identified by a decision maker, a deliberate decoupling from the intuitive mode is required so that corrective “mindware” can be engaged from the analytic mode. “Mindware” is defined as the “rules, knowledge, procedures, and strategies that a person can retrieve from memory in order to aid decision making and problem solving.”4 It includes knowledge about the properties of the particular bias and what strategies might eliminate or reduce it. This process appears to be uncommonly difficult, although there have been some successes. A variety of debiasing strategies have been proposed, and they lead to a few important conclusions: debiasing is not easy, no one strategy will work for all biases, some customization of strategies will be necessary, and debiasing will probably require multiple interventions and lifelong maintenance.

Cognitive failures like those described in the box can be addressed by educational strategies that embrace critical thinking — the “ability to engage in purposeful, self-regulatory judgement.”5Regulating judgment requires training that can permit judicious interventions by the analytic mode when needed — specifically, in its capacity to override the intuitive mode. This critical step has been referred to as decoupling, metacognition, mindfulness, and self-reflection. Most of us never reach our ceilings for critical thinking, and many people go through life unaware of their thinking limitations. We are not born critical thinkers. Like any other skill, however, critical thinking can be taught and cultivated, but even accomplished critical thinkers remain vulnerable to occasional undisciplined and irrational thought.

I believe that medical educators should promote critical thinking throughout undergraduate, postgraduate, and continuing medical education. One key element of training in critical thinking should be a review of the major cognitive and affective biases and the ways they affect thinking. Greater effort is needed to develop effective cognitive debiasing strategies in medicine. All clinicians should develop the habit of conducting regular and frequent surveillance of their intuitive behavior. To paraphrase Socrates, the unexamined thought is not worth thinking.

CLINICAL EXAMPLES OF COGNITIVE FAILURE

 

Case 1

 

A 21-year-old man is brought to a trauma center by ambulance. He has been stabbed multiple times in the arms, chest, and head. He is in no significant distress. He is inebriated but cooperative. He has no dyspnea or shortness of breath; air entry is equal in both lungs; oxygen saturation, blood pressure, and pulse are all within normal limits.

 

The chest laceration over his left scapula is deep but on exploration does not appear to penetrate the chest cavity. Nevertheless, there is concern that the chest cavity and major vessels may have been penetrated. Ultrasonography shows no free fluid in the chest; a chest film appears normal, with no pneumothorax; and an abdominal series is normal, with no free air. There is considerable discussion between the resident and the attending physician regarding the management of posterior chest stab wounds, but eventually agreement is reached that computed tomography (CT) of the chest is not indicated. The remaining lacerations are cleaned and sutured, and the patient is discharged home in the company of his friend.

 

Five days later, he presents to a different hospital reporting vomiting, blurred vision, and difficulty concentrating. A CT of his head reveals the track of a knife wound penetrating the skull and several inches into the brain.

 

Comment: The cognitive failures identified here are “anchoring” and “search satisficing.” The resident and attending staff both anchored onto the chest wound as the most significant injury. When they satisfied themselves that the chest wound was stable, the resident failed to conduct a sufficient search to rule out other significant injuries.

 

Case 2

 

An 18-year-old woman is referred by her family doctor to a psychiatric service for symptoms of severe anxiety and depression. She has been having frequent episodic dyspnea, associated with hyperventilation, carpopedal spasm, and loss of consciousness. The admitting psychiatrist wants to exclude the possibility of a respiratory problem and sends the patient to the emergency department (ED) with a request for a chest film to rule out pneumonia.

 

She is seen and assessed by an ED resident. The patient was not noted to be in any significant distress other than feeling breathless. She is obese, has a history of asthma, and smokes cigarettes. She is currently being treated with a benzodiazepine and anxiolytics and is taking a birth-control pill. Her chest and cardiovascular examination are normal. The resident orders routine blood work and a chest film. He reviews the film, reads it as normal, and believes the patient can be safely returned to the psychiatric facility. He attributes her respiratory problems to anxiety.

 

While she awaits transfer, she becomes very agitated and short of breath. Several nurses attempt to settle her, encouraging her to breathe into a paper bag. Shortly afterward, she loses consciousness. Her monitor shows pulseless electrical activity and then asystole. She cannot be resuscitated. At autopsy, she is found to have pelvic vein thrombosis extending from the femoral vein and saddle emboli in both lungs, as well as multiple clots of varying age.

 

Comment: Several cognitive failures probably influenced the outcome in this case. The patient’s diagnosis of anxiety established “momentum” from her family doctor through to the ED, and although she might well have had hyperventilation due to anxiety, other possibilities were not ruled out earlier on in her care. Furthermore, bias regarding her psychiatric diagnosis probably influenced her care providers; psychiatric patients are more vulnerable to adverse events. “Framing” may also have been a problem, since the psychiatrist had specifically asked the ED to rule out an infective process and had not raised the possibility of pulmonary embolus, despite the patient’s multiple risk factors. “Search satisficing” is again a problem, in that the resident called off the search for a cause for the patient’s dyspnea after ruling out pneumonia.

 
 

Disclosure forms provided by the author are available with the full text of this article at NEJM.org.

SOURCE INFORMATION

From the Division of Medical Education, Dalhousie University, Halifax, NS, Canada.