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This is an extensive critique of a short article about laparoscopic versus open gastric bypass surgery. The article looks at the early posoperative outcomes of the two surgeries, comparing lengths of hospital stays, complications, weight loss, and return to normal activities. Concludes that the article is a simple observational study.

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A The researchers in this study are looking to see if there is adifference between the early postoperative outcomes of laparoscopic gastricbypass surgery and open gastric bypass surgery The problem is statedclearly The problem is important to nursing in that the laparoscopicprocedure resulted in shorter hospital stays and in terms of the types ofcomplications seen after the two types of surgeries The problem was avery simplistic one which merely involved assessing the early outcomes ofthe two types of procedures and was very

There is noindication given of whether or not there were any subjects who chose not toparticipate in the study. There are no threats to internal validity in this study. Astandardized protocol was used for all patients pre-operatively and post-operatively. (2 3). Itis a simple study, and does not need any complex design. The independent variable ismorbid obesity; the dependent variables are the two types of surgery.D. Data collection was by the 36-question Health Survey SF-36questionnaire, patient body measurements at one, three, six, 9, and 12months post-surgery (percent excess bodyweight, BMI) and from patienthospital records. The concepts are the variables in this study; the constant isthat all the patients were morbidly obese. The reliability of thequestionnaires is their validity as a testing instrument which has beenproven previously, and the fact that the values of the scores on thesequestionnaires for patients were in line with the values obtained on thesequestionnaires for the normal U.S. Data for all patients wasanalyzed on an intention to treat basis. This study wassimply comparing the outcome of two techniques used for addressing the sameproblem. Because there was no hypothesis or question, there was no need toquestion their consistency with the purpose and conceptual framework of thestudy.G. had an effect on the patients' physical and mental health. Theresearchers did not base their study on previous research. Patientswere asked about the time it took to return to normal activities, andfilled out a 36-question Health Survey (SF-36) questionnaire at the longestfollowup point from surgery. The major variables were length of hospital stay, surgical complications,weight loss, and time to return to normal activities. Statistical significance wasconsidered if P< . The literature review is virtually non-existent. Also, baselineSF-36 values could have been taken and compared to those taken one yearfollowing surgery to see if the surgery made any changes in these values,i.e. To improve the study, longer termfollowup is necessary and administration of the SF-36 prior to as well asafter the surgery would have given some insight into the physical andmental benefits from such surgery. Weight loss following surgery wassignificantly better at three, six and 9 months in the laparoscopic group,but there was no difference at 12 months, with the laparoscopic gastricbypass surgery group losing 69 percent of their excess body weight and theopen gastric bypass surgery group losing 65 percent of their excess bodyweight. Primary sources, such as they were, were used in theliterature review.F. The stated purpose of the study was to evaluate the earlypostoperative outcomes of laparoscopic gastric bypass surgery with opengastric bypass surgery using a matched pair analysis. Because the aim of the study was the comparison ofthe early postoperative benefits of two alternative procedures for the sameproblem, there is no generalization possible from these results. Works CitedCourcoulas, A., Perry, Y., Buenaventura, P., & Luketich, J. population.L. Since the study was conducted at the Universityof Pittsburgh Medical Center, there is no reason to believe the patients'records were not accurate. The findings of the study were that hospital length of stay was .7days less for those patients who had laparoscopic gastric bypass surgerycompared to those who had open gastric bypass surgery. The problem was avery simplistic one, which merely involved assessing the early outcomes ofthe two types of procedures. Percent excess body weight and BMI wasmeasured at one, three, six, 9, and 12 months at office visits. Obesity Surgery, 13, 341-346 The patients were specified asbeing "consecutive" patients on which the procedures were performed, so itis not known if they were even consulted about being part of a study.Since there is no information given on whether or not patients rights wereprotected, and if so, how, it is impossible to determine if there were anyviolations of the rights of the human subjects.I. and was very simple to study because all itinvolved was determining the number and type of complications suffered byeach group of patients, their length of hospital stay, time to return tonormal function, and outcome in terms of weight loss produced.B. A. No research questions were being proposed. It is simply a comparison between two techniques. The quality of life survey showed thesepatients scored no differently than the average U.S. The worst score ( ) represents poor health and the best score (1 )represents good health. They onlyhave relevance for a specific group of patients with specific problems.J. The researchers concluded correctly that inthe short-term laparoscopic gastric bypass surgery is as safe and effectiveas surgical gastric bypass surgery, and that both groups enjoy the benefitsof a greatly improved quality of life. There is no mention of whether the patientswere asked to sign informed consent forms. It is not testing any theoretical concept. The design of the study involved following 8 laparoscopic gastricbypass patients with 8 matched open gastric bypass patients over a oneyear period. The gastrojejunal anastomosis was created using alinear stapler and a hand-sewn closure with a reinforcing fascial band. Asimilar technique was used for the laparoscopic gastric bypass, but using a21 mm circular or linear stapled and hand-sewn gastrojejunal anastomosiswith no reinforcement. There is no reason to believe the informationfrom patient questionnaires, and the patient measurements recorded wereinaccurate for the same reason. There is only one concept involvedso there is no need to link concepts. It is a comparative study of established techniques.There is no framework to relate the study to. 5. population on eitherthe individual or component summary scales.Summary. Very little background is given regarding thestudy except to say that there are very few scientifically controlledstudies in the literature, and that with the widespread dissemination ofinformation over the internet, it would be very difficult to get patientsto volunteer to be randomly assigned to open surgery for this procedurewhen it can be performed laparoscopically, and now that laparoscopicsurgery is the treatment of choice for morbid obesity.C. This was a non-probability sample since there wasno probability of any particular outcome. The problem is statedclearly. They devisedtheir own study because there was a lack of previous research on the chosentopic. It is a simple observationalstudy, not a theoretical one.E. This design is appropriate, considering the topic of the study. The statistics showed means andstandard deviations for continuous data, and medians for non-normallydistributed data. There were no descriptive tests used to describe the major variables. The reduced hospital stay in patientsundergoing laparoscopic gastric bypass surgery compared to open bypasssurgery is only .7 days, which really amounts to nothing, since in termsof hospital discharge, this amount of time can accrue merely by having towait for someone to pick up the patient, so can hardly be attributable tosurgical technique. It only cites tworandomized studies of the problem, and gives absolutely no detailswhatsoever about these studies: it just says there were two previousstudies. The findings of the study are not compromised as aresult of the data collection methods used because there is no other way tocollect the data for this study.K. The researchers provide no evidence that the rights of human subjectswere protected in any way. The only way it would not be valid was ifthe patients' records were faked in some way, or that patients' recordswere not kept accurately. The change in BMI at 12 months was 29.61 for the laparoscopicgastric bypass surgery group and 31.3 for the open gastric bypass surgerygroup. There onlyreal threats to external validity in this study, given the aim of thestudy, are that the study was carried out at only one hospital, and theremay be variations in surgical methods, treatments, nursing care, etc atother hospital which may affect the results. There can be no control group in thistype of study. The sample size was 8 patients having laparoscopic gastric bypasssurgery and 8 patients having open gastric bypass surgery. Continuous data was presented as mean+ standard deviation with a median calculated for non-normally distributeddata. The reliability for the post-operativeeffects of the two different types of surgery is the credibility of thepatients, and the accuracy of patients' records. Statistical analysis was carriedout using the SPSS software program. One patient died of complications following theopen gastric bypass surgery. There is no theoretical frameworkinvolved in this study. Outcome variables included length of hospital stay in days, andmajor and minor complications. The SF-36 measure eight health concepts:physical functioning (limitations in performance); role-physical(limitations in daily activities as a result of physical health); role-emotional (limitations in daily activities as a result of emotionalproblems); bodily pain (measures pain related to functional limitations);vitality (measures energy level); mental health (measures the presence anddegree of depression and anxiety); social functioning; and mental health(measures and individual's perception of his/her overall health). Demographic data, BMI, and obesity-related co-morbid conditions wererecorded. In the open gastric bypass patients, the gastric pouch waspartitioned and the Roux limb was brought to the pouch by a retrocolic,antegastric route. It is difficult to assess return to normalactivities because of the large standard deviations of the two groups, asthe raw data are not given. The problem is important to nursing in that the laparoscopicprocedure resulted in shorter hospital stays and in terms of the types ofcomplications seen after the two types of surgeries. The validity of the data is the fact that it is taken from patientrecords or patient measurements. The literature review did not guide the study because there wasnothing found to guide it, with only two previous studies being found. It islooking at practical outcomes from two differing procedures for treatingthe same problem. Thephysical comparisons are appropriate to assess the results, considering theaims of the study. Patients were matched by age (within 1 years), gender, pre-operative body mass index (BMI) (within 5 kg/cm2 units), and number of co-morbid medical conditions (1 to 3 with 1 to 3, 4 to 6 with 4 to 6). There was a trendto more major complications for patients having laparoscopic gastric bypasssurgery, but it was not significantly different to that for patients havingopen gastric bypass surgery. Also, the ethnic makeup ofthe patient population is not specified, and there may be ethnic factorsin the causes of morbid obesity which may affect the outcome. The results cannot begeneralized because they only affect a particular segment of society - themorbidly obese, or the obese with co-morbid medical problems requiringgastric bypass surgery. Baseline comparisons and comparisons at one year to anon-operated control group who were treated by diet/exercise programs wouldhave been interesting to see how effective gastric bypass is at helping themorbidly-obese lose weight compared to non-surgical means. There are no stated research hypothesis because no hypothesis wasbeing tested. The concept is defined as the difference in outcomesbetween the two procedures, and is defined conceptually as the overallbenefit of one procedure over the other, and operationally as the actualoutcomes observed in terms of medical complications, length of hospitalstay, etc. Two summary scores, one for physical componentscore (PCS) and one for mental component score (MCS) were calculated, witha score of 6 representing optimal health. The pouch was 15 ml in size and the Roux limb was15 cm in length. The difference in time to return to normal daily activities was 7.3+7weeks for the laparoscopic group and 9.8+16 for the open surgery group.These figures are obviously reported erroneously because they would thatsome of the patients who had laparoscopic surgery returned to workimmediately, and some of those who had open surgery returned to work beforethey even had the surgery! No rationale was given for the sample size.The sample size of 8 patients in each groups seems large enough given thenature of the study, particularly since the results were fairly consistentthroughout each group. The purpose of thestudy was clearly stated. Theresearchers also note that the laparoscopic gastric bypass was a relativelynew procedure at the hospital and this may have influenced the rate ofcomplications post-operativelyH. There are no specific gaps in knowledge pointed out in theliterature review because there was no literature as such to review. No inferential testswere used to analyze the material. The researchers in this study are looking to see if there is adifference between the early postoperative outcomes of laparoscopic gastricbypass surgery and open gastric bypass surgery. However the findings donot seem to have much significance. The sample size was a strong point of the study, with8 patients in each group. The theoretical framework for the study is that laparoscopic surgery,because it is less invasive, and usually involves a much shorter hospitalstay and much shorter recovery time, will produce a better earlypostoperative result than open surgery. The strength of the study is that it set out to evaluate theearly postoperative outcomes of two operative techniques for in morbidlyobese people and it did just that, and no more. There is no indication given that any patientsdropped out of the study. The concept of this study are that laparoscopic gastric bypasssurgery will provide different early postoperative outcomes to open gastricbypass surgery. Continuous data were analyzed for differences between pairs usingWilcoxon Signed Ranks. Categorized, discrete data were analyzed fordifferences among pairs by the McNemar test. Noinformation was available on the subject of the study, so there were noknown gaps to fill in: the whole topic was a gap in the availableliterature. "Comparing the outcomes after laparoscopic versus open gastric bypass: a matched paired analysis. There were no inferential tests used so there is noquestion of the appropriateness.M. It is unethicalto perform sham operations as controls, or to carry out the procedure onnon-obese individuals as controls.

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