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a Division of General Thoracic Surgery, Mayo Clinic College of Medicine, Rochester, Minnesota
b Division of Biostatistics, Mayo Clinic College of Medicine, Rochester, Minnesota
Accepted for publication February 28, 2008.
* Address correspondence to Dr Deschamps, Division of General Thoracic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (Email: deschamps.claude{at}mayo.edu).
| Abstract |
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Methods: This was a matched paired analysis with retrospective chart review and follow-up questionnaire of 116 patients undergoing transabdominal fundoplication with gastroplasty with 116 matched controls undergoing transabdominal fundoplication alone from January 1997 to June 2005. Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and Quality Of Life in Reflux And Dyspepsia (QOLRAD) instruments were used to measure overall and reflux-related QOL. Overall response rate was 75%; including 65 matched pairs used for long-term follow-up and QOL analysis.
Results: Groups were similar in age, sex, duration of hospitalization, and complications (p > 0.05). Gastroplasty patients had larger hiatal hernias and were more likely to have undergone a previous fundoplication (p < 0.01). No perioperative deaths or major morbidity occurred in 18% of both groups. Survey respondents were older than nonrespondents (p < 0.01). Complications did not impact response rates (p = 0.11). Median follow-up was 14 months in the gastroplasty group and 17 months in controls (p = 0.02). The groups had similar scores on the SF-36 and QOLRAD (p > 0.05) and similar overall frequency of patient satisfaction, perceived health status, and self-reported symptoms of reflux, dysphagia, bloating, diarrhea, and excessive flatus (p > 0.05). Control patients were more likely to require rehospitalization or reinterventions (p = 0.04).
Conclusions: Transabdominal gastroplasty and fundoplication for shortened esophagus is safe and results in similar overall and reflux-related QOL compared with fundoplication alone.
| Introduction |
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This study investigated the effects of gastroplasty and presence of the resultant neoesophagus on overall and reflux-related quality of life (QOL). We hypothesized that transabdominal gastroplasty and fundoplication with hiatal hernia repair would result in impaired QOL compared with matched controls undergoing hiatal hernia repair and transabdominal fundoplication alone.
| Material and Methods |
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Between September 1999 and June 2005, 626 transabdominal hiatal hernia repairs were performed at our institution. From this group, we identified 119 (19%) consecutive patients who underwent gastroplasty for a shortened esophagus. Three refused permission to participate in research studies, leaving 116 patients who gave consent and whose results were analyzed. A group of 116 control patients was identified in a matched-paired fashion from a list of all fundoplications performed at our institution between January 1997 and June 2005. Controls were matched for sex, operative approach (laparoscopic vs open), type of fundoplication (partial vs Nissen), and within 4 years for the variables of age and time from operation. Matching variables are reported in Table 1. Time from operation was the only matching variable that differed between the groups (p < 0.01). Each gastroplasty patient was matched with a control patient in a matched-paired fashion. For the matched-paired analysis, data were analyzed only if the gastroplasty patient and the exact matched control both returned the survey. To eliminate bias, all matching was performed before survey mailing and data acquisition. No post hoc analysis or postanalysis matching was performed.
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Chart Review and Operative Technique
Patient records from our institution were reviewed retrospectively. We collected data on patient demographics at the time of operation, medical history, evaluation of hiatal hernia and reflux symptoms, operative data, morbidity, mortality, postoperative hospital stay, and follow-up data. We also collected follow-up data pertaining to reflux symptoms and hiatal hernia as well as any evidence of recurrence or further intervention related to the operative procedure.
A short esophagus was diagnosed by the operating surgeon at the time of hiatal hernia repair if the surgeon was unable to achieve a 2 to 3 cm length of intraabdominal esophagus without tension after adequate esophageal mobilization [1, 2]. The techniques used by our group to perform a transabdominal gastroplasty have been described previously in detail [1]. Briefly, a cut Collis gastroplasty was performed by creating a neoesophagus from the lesser curvature by first applying an EEA stapler (United States Surgical Corp, Norwalk, CT) through the body of the stomach 2 to 5 cm distal to the angle of His calibrated by a bougie. This was followed by the application of one or two firings of a gastrointestinal anastomosis stapler (GIA, United States Surgical, Norwalk, CT) oriented toward the angle of His to effect a gastroplasty [1–3]. Alternatively, wedge gastroplasty was performed by removing a wedge of greater curvature oriented toward the angle of His calibrated by a bougie to effect a 2 to 4 cm gastroplasty [1, 6, 7].
Both methods of gastroplasty were followed by either a Nissen (360°) or Toupet (180°) fundoplication. The decision to perform a Toupet or Nissen fundoplication was by surgeon preference. We routinely perform a Nissen fundoplication, and the Toupet fundoplication is generally performed in those patients with poor esophageal motility.
All operations were performed by 5 surgeons either currently, or previously, in our group. Control patients were drawn from all 5 surgeon's practices, whereas 4 surgeons performed either a cut Collis or wedge gastroplasty selectively. Three surgeons contributed most of the patients to this study, which is a consequence of our referral patterns and individual practices. Major complications were defined as those that required additional intervention, prolonged hospitalization, or resulted in readmission within 30 days of operation.
Questionnaire
Patients in both groups were mailed a follow-up questionnaire which contained 14 generic questions as well as the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) [8] and the Quality Of Life in Reflux And Dyspepsia (QOLRAD) [9], both validated QOL questionnaires. Patients were asked to answer questions about general health, reflux symptoms, and their prevalence, diarrhea, dysphagia, chronic cough, postprandial bloating, and difficulty belching. Patients were also asked to report further interventions for reflux or hiatal hernia, medical treatment, and satisfaction.
The SF-36 is a validated instrument used extensively in health care research to evaluate overall QOL [8]. It consists of eight domains (physical functioning, role-physical, pain index, general health perceptions, vitality, social functioning, role-emotional, and mental health index) and two composite scores (mental component scale, and physical component scale). The maximum score possible for each component of the SF-36 is 100.
The QOLRAD is a validated instrument used to measure the effects of gastroesophageal reflux and dyspepsia on QOL [9]. It consists of five domains (emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality) designed specifically to evaluate the effects of symptoms related to upper gastroesophageal disorders on QOL and social functioning. There are two versions of the QOLRAD; one is used to evaluate dyspepsia, and the other used in our study was designed to evaluate reflux. This latter version used to evaluate reflux correlates well with other QOL instruments, including the SF-36, as well as the relief of reflux symptoms after fundoplication [9–11]. The maximum score possible for each component of the QOLRAD is 7.
Both questionnaires are self-administered by the patient, do not require health provider assistance, and have high rates of concordance and reproducibility [8, 9]. Nonresponders were mailed a second and third questionnaire; a phone call reminder was also performed after the third questionnaire was mailed.
Response to Questionnaire and Follow-Up
Questionnaire response rates were 77% (89 of 116) for the gastroplasty group and 74% (84 of 113) for the control group (p > 0.05). There was no association between the occurrence of a complication and response to the survey (p = 0.11); however, survey respondents were older than nonrespondents (median age, 69 vs 61 years, p < 0.01). For 65 matched pairs, both the gastroplasty patient and the matched control, as identified by prestudy matching, returned the survey questionnaire. These were used for QOL and symptom analysis, and all 116 patients from each group were used to compare preoperative and perioperative data.
Median follow-up was 14 months (range, 1 to 70 months) for the 116 gastroplasty patients and 17 months (range, range 0 to 78) for the control patients (p = 0.02). The median follow-up for the 65 matched pairs used in the QOL and symptoms analysis was 17 months (range, 2 to 66 months) in the gastroplasty group and 26 months (range, 3 to 71 months) in the control group (p < 0.01). We routinely obtain follow-up imaging at 1 to 2 months postoperatively, accompanied by a follow-up visit. We encourage patients to return yearly thereafter for clinical follow-up and imaging. We do not routinely obtain follow-up esophageal manometry and 24-hour pH monitoring. Referral patterns are such that many patients travel long distances and do not return yearly for follow-up. Recurrence was defined as anatomic recurrence and not recurrence of symptoms.
Statistical Analysis
Assuming a standard deviation of 20 points on a 100-point scale for both the SF-36 and QOLRAD questionnaires, 50 patients would be needed in each group to achieve statistical power to detect a difference of 10 points with 80% confidence and p = 0.05. A difference of 10 points has been identified as a clinically meaningful difference in QOL measures by Sloan and colleagues [12].
For survey respondents, all outcomes were compared between cases and controls using the Wilcoxon signed rank test for continuous outcomes and the McNemar test for categoric/dichotomous outcomes [13]. Continuous data from chart review were compared using a two-tailed Student t test or the Wilcoxon–Mann-Whitney test and categoric data using the
2 test. Test statistics with an associated probability of p
0.05 were considered statistically significant unless otherwise noted. Values are reported as the median (range) or number (%). The QOL scores are reported as the median ± interquartile range. All analysis was conducted using SAS 9.3 software (SAS Institute, Cary, NC).
| Results |
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In the gastroplasty group, 3 patients (3%) required reoperation within 30 days. One patient experienced a fascial dehiscence after a laparotomy, Nissen fundoplication, and wedge gastroplasty and required operative fascial closure. In a second patient, esophageal perforation was diagnosed at another hospital 20 days after a laparoscopic Nissen fundoplication and wedge gastroplasty, which required esophagectomy. Reoperation on postoperative day 3 was required in a third patient when a leak developed from the staple line after a laparoscopic Nissen and wedge gastroplasty. The leak was oversewn successfully with revision of the Nissen fundoplication, and the patient left the hospital on postoperative day 17. Two patients (2%) in the control group required reoperation within 30 days. One patient was reexplored for a suspected fascial dehiscence with a deep wound infection after a laparotomy and Nissen fundoplication. The other patient required two reoperations for a subphrenic abscess, gastrocutaneous fistula, and fascial dehiscence after a laparoscopic Nissen fundoplication.
Postoperative QOL and Symptoms
Reflux-related and overall QOL in the 65 matched pairs did not differ between the gastroplasty and control groups as determined by the QOLRAD and SF-36 survey questionnaires, respectively (Fig 1
and Fig 2). Both groups had high reflux-related QOL scores in all five components of the QOLRAD questionnaire. We then analyzed the SF-36 and QOLRAD scores for all survey respondents in both groups (77% of the gastroplasty group and 72% of the control group) in a non-matched-paired analysis. The results of this analysis again showed no difference in QOL scores between the two groups for all eight domain and two component scores of the SF-36 and the five component scores of the QOLRAD.
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| Comment |
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The goal of our study was to determine the effect of transabdominal gastroplasty and fundoplication on QOL compared with a group of control patients who underwent fundoplication alone during the same time period. We showed that gastroplasty and fundoplication results in similar QOL compared with fundoplication alone in a group of matched controls. In addition, gastroplasty patients experienced the same rate of complications, with no difference detected in the incidence of postoperative symptoms and a similar recurrence rate, even though patients in the gastroplasty group had, on average, a larger hiatal hernia and therefore likely a greater degree of esophageal shortening.
The QOL scores seen in the current study for both the gastroplasty and control groups are consistent with those reported by others. Richards and colleagues [11] reported an average QOLRAD score of 6.2 of 7 possible after laparoscopic fundoplication in 75 patients, 8 of whom underwent a Collis gastroplasty. Although we reported median values, the mean scores in our study were 6.0 to 6.7 for both groups. Similarly Dassinger and colleagues [10] reported an average QOLRAD score of 5.9 after laparoscopic fundoplication, which is also congruent with our results. Other authors have used the Gastroesophageal Reflux Health-Related Quality-of-Life scale (GERD-HRQOL) to evaluate patients before and after fundoplication, with good correlation between postoperative scores and satisfaction [5, 17–19].
The SF-36 scores also correlate with good outcomes after fundoplication [17, 18, 20]. Although most other studies used an earlier version of the SF-36 questionnaire, the scores reported by other groups are similar to our results [17, 18, 20]. The high QOLRAD scores we observed in both groups from the current study (9 of 10 reaching a median maximum score) were enlightening. The mean score observed in normal controls has been reported to be 6 of 7 possible, whereas those patients with reflux without operative repair achieve scores of 3.5 to 5.5 [9, 10]. In addition, mean QOLRAD scores after fundoplication in nonselected cohorts with good outcomes have been reported to be about 6 [10, 11]. These previous results suggested that the QOLRAD questionnaire was a good choice for the present study and for this population.
The high scores seen in both groups have two potential implications. First, with most patients achieving the maximum possible score, our ability to detect differences between the two groups (control and gastroplasty) was compromised. The second possible implication is that reflux symptoms do not affect QOL significantly in either group, suggesting both groups experienced good outcomes in control of reflux symptoms.
Pierre and colleagues [5] reported QOL scores and clinical results for 203 patients with giant paraesophageal hernias who underwent attempted laparoscopic repair, 113 of which included a gastroplasty. The authors included patients with at least one-third of the stomach within the chest on barium esophagram, similar to the gastroplasty population in the current study. They showed excellent QOL scores after repair in 84% of their patients. The incidence of postoperative complications was 28% and was similar to our 18% incidence of major complications. The leak rate in their study was 3%, similar to the 3% in our gastroplasty group and 2% in the controls.
Our study has several limitations. First, the current study is a retrospective, matched paired cohort study and therefore carries the burden inherent in all retrospective studies.
Second, as with most retrospective studies, the two groups being compared were different. The follow-up was significantly greater in the control group, which may have allowed more time for recurrent symptoms or other problems to develop compared with the gastroplasty group and therefore impact results. Although we tried to correct for this in our matching process by restricting the operative dates to within 4 years for the controls, a significant difference was still present. The differences in follow-up likely stem from the evolution of our practice during the years studied that represent changes in practice patterns.
Another difference between the two groups was the size of the hiatal hernia; gastroplasty patients had larger hiatal hernias (6 cm vs 3 cm). Despite this disparity, however, both groups had similar rates of complications, recurrence, and satisfaction, as well as postoperative symptoms. The gastroplasty group with larger hiatal hernias might have been expected to have higher recurrence rates, poorer outcomes, and possibly even greater rates of operative complications compared with the control group with smaller hernias; this was not the case. Hiatal hernia size was not a factor used when identifying control patients; having done so may have made the groups more homogeneous.
The third limitation of the current study is a lack of preoperative QOL data, which does not allow us to document individual patient improvement postoperatively.
In conclusion, transabdominal gastroplasty and fundoplication for shortened esophagus is safe and results in similar overall and reflux-related QOL compared with fundoplication alone.
| Acknowledgments |
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| References |
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