Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study.

BACKGROUND: This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP). METHODS: A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed. RESULTS: One hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4-4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0-6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0-10] at baseline to 0 [0-3] at 1 month (P < 0.001) and remained low at 24 months 0 [0-6] (P < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative. CONCLUSIONS: The use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation. TRIAL REGISTRATION: The study was registered publically at clinicaltrials.gov ( NCT01848184 registered May 7, 2013).

Quality of life convergence of laparoscopic and open anti-reflux surgery for gastroesophageal reflux disease.

Although laparoscopic anti-reflux surgery (LARS) has become the surgical treatment of choice for gastroesophageal reflux disease (GERD), it is unclear whether the quality of life (QoL) advantage of LARS over open anti-reflux surgery (OARS) persists in the long term. The purpose of this study was to compare long-term QoL between LARS and OARS patients. A prospectively gathered database of all patients who underwent either LARS or OARS for symptomatic GERD was reviewed. Preoperatively, patients completed the GERD- health-related quality of life (HRQL) symptom severity questionnaire (best score 0, worst score 50), and the Medical Outcome Short Form (36) (SF-36) generic bodily QoL instrument (eight domains, physical functioning, PF; role - physical, RP; role - emotional, RE; bodily pain, BP; vitality, mental health, social functioning, SF; general health, best score 100, worst score 0). Postoperatively, patients completed both questionnaires at 6 weeks and a least 1 year. Data are presented as medians and statistically analyzed using the Mann-Whitney U-test. A beta-error was determined to assess adequacy of sample size. A total of 289 patients underwent LARS and 124 OARS. At 6 weeks there were statistically significantly better scores for LARS in the domains of PF, RP, RE, BP and SF. However, after 1 year, there were no statistically significant differences. The beta-error for non-statistically significant differences were all < 0.2, which is considered an adequate sample size. Although LARS does produce better QoL scores in the early postoperative period, after 1 year, these scores converge.

The use of tissue sealant to prevent fistula formation after laparoscopic distal pancreatectomy.

BACKGROUND: Pancreatic fistula occurs in about 20% of patients undergoing laparoscopic pancreatectomy. A variety of techniques have been described to decrease this rate, with limited success. Fibrin sealants are products that promote the adhesion of tissue surfaces to each other. This report demonstrates the use of fibrin sealants to decrease the incidence of pancreatic fistula. METHODS: After completion of the laparoscopic or hand-assisted distal pancreatectomy, 5 ml of fibrin sealant (Tisseal; Baxter Healthcare, One Baxter Parkway, Deerfield, IL, USA) is applied to the cut edge of the pancreatic remnant. Omentum, which has been dissected to expose the raw surface, is then applied over the pancreatic remnant and fastened to the cut edge by the fibrin sealant. A drain is placed over the omentum in the left upper quadrant. Postoperative computed tomography (CT) scans are obtained on postoperative day 3 to determine whether any fluid collections are present. A pancreatic fistula is defined as any amylase-rich fluid found in the drain or any juxtaposed fluid collection next to the pancreatic remnant on postoperative day 3. RESULTS: A total of eight patients underwent laparoscopic distal pancreatectomy with the use of fibrin sealant. These were compared with the previous 13 patients who underwent laparoscopic distal pancreatectomy without fibrin sealant. No patients in the fibrin sealant group experienced pancreatic fistula, as compared with three patients (23%) in the no sealant group. CONCLUSIONS: Although this series was small, it does suggest that the use of fibrin sealant may reduce the incidence of postoperative pancreatic fistula formation after laparoscopic distal pancreatectomy.

The development of the GERD-HRQL symptom severity instrument.

The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument was introduced approximately 10 years ago to provide a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). Since that time the instrument has been used to assess treatment response to medication, endoscopic procedures, and surgery for GERD. However, the development of the instrument has progressed over the course of several years, and there is no one source which reviews this progress. The purpose of this article is to summarize the development and testing of the GERD-HRQL. The GERD-HRQL was initially developed to measure the typical symptoms of GERD. It was initially determined to have face validity and subsequent studies assessed its content validity, criterion validity, concurrent validity, predictive validity and construct validity. Reliability was determined by the test-retest method. Responsiveness was determined by the effects of treatment. This instrument is practical, with little administrative burden. There are few missing responses. Because there are 51 possible scores, the instrument has a high level of precision; and because of the response anchors, cannot have a floor effect, and only 4/372 patients reached the highest score of 50, implying little ceiling effect. The instrument has been translated into several languages, and appears valid, reliable and practical in each.

Endoscopic endoluminal radiofrequency ablation of Barrett's esophagus in patients with fundoplications.

BACKGROUND: Endoscopic endoluminal radiofrequency ablation using the Barrx device is a new technique to treat Barrett's esophagus. This procedure has been used in patients who have not had antireflux surgery. This report is presents an early experience of the effects of endoluminal ablation on the reflux symptoms and completeness of ablation in post-fundoplication patients. METHODS: Seven patients who have had either a laparoscopic or open Nissen fundoplication and Barrett's esophagus underwent endoscopic endoluminal ablation of the Barrett's metaplasia using the Barrx device (Barrx Medical, Sunnyvale, CA). Preprocedure, none of the patients had significant symptoms related to gastroesophageal reflux disease. One to two weeks after the ablation, patients were questioned as to the presence of symptoms. Preprocedure and postprocedure, they completed the GERD-HRQL symptom severity questionnaire (best possible score, 0; worst possible score, 50). Patients had follow-up endoscopy to assess completeness of ablation 3 months after the original treatment. RESULTS: All patients completed the ablation without complications. No patients reported recurrence of their GERD symptoms. The median preprocedure total GERD-HRQL score was 2, compared to a median postprocedure score of 1. One patient had residual Barrett's metaplasia at 3 months follow-up, requiring re-ablation. CONCLUSIONS: This preliminary report of a small number of patients demonstrates that endoscopic endoluminal ablation of Barrett's metaplasia using the Barrx device is safe and effective in patients who have already undergone antireflux surgery. There appears to be no disruption in the fundoplication or recurrence of GERD-related symptoms. Nevertheless, longer-term follow-up with more patients is needed.

The lasso technique for laparoscopic distal pancreatectomy.

BACKGROUND: Laparoscopic distal pancreatectomy with or without splenectomy is becoming an acceptable alternative to open resection for selected pancreatic lesions. One of the difficulties with this approach is manipulating the pancreas with laparoscopic instruments to avoid unnecessary injury to the pancreas, and yet obtain adequate margins. The described technique accomplishes these goals. METHODS: Data from all patients who underwent laparoscopic distal pancreatectomy (always with splenectomy) were reviewed for age, gender, laparoscopic completion of the resection, postoperative complications, length of hospital stay, and pathology. The essential component of the technique is use of a Penrose drain around the neck or proximal body of the pancreas as a "lasso" for atraumatic manipulation. This technique is described in detail. RESULTS: A total of 11 patients have undergone laparoscopic distal pancreatectomy with splenectomy using the lasso technique. Two patients (18%) underwent conversion to an open laparotomy: the because of bleeding from the pancreatic parenchyma and the other due to local invasion of a pancreatic adenocarcinoma. The average operating time was 162 +/- 39 min, and the median length of hospital stay was 3 days. There were two (18%) pancreatic leaks, both of which were treated conservatively with resolution. Pathologic examination, found six cystic neoplasms, two neuroendocrine tumors, two masses of chronic pancreatitis, and one adenocarcinoma. CONCLUSIONS: The lasso technique simplifies intraoperative manipulation of the pancreas during laparoscopic distal pancreatectomy. It allows for safe manipulation of the pancreas and may expand the indications for the laparoscopic approach to pancreatic resection.

Qualitative analysis of the expectations of antireflux surgical outcomes of patients from different nationalities.

Patient-reported outcomes have grown in importance in assessing the value of a variety of treatments. One of the methods of assessing patient-reported outcomes is qualitative analysis. The purpose of this study was to assess if qualitative analysis can be used to assess patient expectations for antireflux surgery in different nationalities. Patients referred for antireflux surgery (ARS) in the US, Austria and Italy were prospectively studied. Preoperatively, they were asked: (i) 'How do you expect the surgery to affect your symptoms?'; (ii) 'What do you expect the possible complications or side effects to be?' These patients then underwent open or laparoscopic antireflux surgery. At 2-3 months postoperatively, they were asked: (i) 'Are you satisfied with your surgery? If so, why? If not, why not?'; (ii) 'Did your surgery meet your expectations? If not, why not?' Twenty patients in the US, 24 in Austria, and 18 in Italy completed the study. Preoperatively, there were significant differences between the patients in demographics and objective measurements of GERD. Symptomatic relief was the most common expectation. There was variation in question #2, with Austrian and Italian patients more likely to mention conversion and postoperative side effects. Postoperatively, 90% of American, 88% of Austrian, and 89% of Italian patients were satisfied. Causes for dissatisfaction were postoperative complications, symptomatic recurrences, or side effects. Ninety percent of American, 96% of Austrian, and 94% of Italian patients said that their expectations were met. Patients who did not mention the possibility of side effects or complications were more likely to be dissatisfied. Qualitative analysis is a useful tool in assessing patient expectations. Expectations were remarkably similar. Patients who did not mention postoperative adverse events as possibilities preoperatively were more likely to be dissatisfied.

Analysis of the SAGES outcomes initiative cholecystectomy registry.

BACKGROUND: In 1999, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) introduced the SAGES Outcomes Initiative as a method for its members to use for tracking their own outcomes. This report provides a descriptive analysis of the cholecystectomy database. METHODS: The SAGES Outcome Initiative database was accessed for all gallbladder cases from September 1999 to February 2005. The data from the preoperative, intraoperative, and postoperative entries were summarized. These data are purely descriptive, and no statistical analysis was performed. RESULTS: The gallbladder registry contained 3,285 cases, with 2,005 follow-up cases. Most patients were employed women with some comorbidities who had elective surgery under general anesthesia. Most of the operating surgeons were attending surgeons and surgical assistants. Most of the patients had biliary colic, and symptoms were improved for more than 95% of the patients. More than 90% of the cases were managed laparoscopically, with a conversion rate of 3%. Biliary imaging was used in the vast majority of cases, with most shown to be normal. Intraoperative gallbladder perforation was common, with bile duct injury occurring in 0.25% of cases. The most frequently cited postoperative event was wound infection, with most complications classified as class 1. More than 95% of the patients were able to return to work. CONCLUSIONS: The SAGES Outcomes Initiative database demonstrates that most participating SAGES members perform laparoscopic cholecystectomies themselves using intraoperative cholangiograms. Adverse outcomes are few, with most patients able to return to normal activity. Importantly, there were relatively few missing data points, implying that when surgeons enter data, the information is relatively complete.

Analysis of the SAGES Outcomes Initiative groin hernia database.

BACKGROUND: In 1999, the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) introduced the SAGES Outcomes Initiative as a way for its members to track their own outcomes. It contains perioperative and postoperative data on nearly 20,000 operations. This report provides a descriptive analysis of the groin hernia database. METHODS: The SAGES Outcomes Initiative database was accessed for all groin hernia cases from September 1999 to February 2005. The data from the preoperative, intraoperative, and postoperative entries were summarized. These data are purely descriptive and no statistical analysis was done. RESULTS: The hernia registry contains 1,607 entries, with 1,070 follow-up entries. Males comprised 85% of patients, 63% were employed, 62% had at least one comorbidity, with 84% ASA class I or II. Primary, unilateral hernia accounted for 86% of cases, whereas 14% were recurrent, 11% bilateral, 6% incarcerated, and 3% required emergency repair. The operating surgeon was the attending surgeon in 83% of cases. Anesthetic techniques were general anesthesia in 74% of cases, regional in 7%, and local in 34%, with only 16% of cases local only. Most patients had symptomatic hernias and symptoms were improved in more than 95% of patients. Most repairs were open, although 45% were endoscopic. The most frequently cited postoperative event was significant bruising (6%), with more than 99% of complications being class I or II. More than 95% of patients were able to return to work by the first postoperative visit. Patients who underwent endoscopic repair were reported to have fewer days of narcotic use than patients undergoing open repairs (0 vs 3). CONCLUSIONS: First analysis of the SAGES Outcomes Initiative groin hernia database demonstrates that (a) this is one of the largest prospective; voluntary hernia registries; (b) missing data are infrequent; and (c) the data are similar to published data from national, mandatory registries and randomized trials. Although the SAGES Outcomes Initiative is a voluntary registry, initially designed for surgeon self-assessment, and it therefore has the potential for methodological concerns inherent to voluntary registries, the findings from this first analysis are encouraging. Efforts are ongoing to simplify data entry (PDA), refine data parameters, increase surgeon participation, and determine the role of data audit and thereby the potential for clinical research.

Nonsurgical factors affecting symptomatic outcomes of antireflux surgery.

A small number of patients will have persistent or new symptoms after antireflux surgery for gastroesophageal reflux disease (GERD). Most of these symptoms are due to recurrent reflux or some complication or side-effect of the operation. However, a few of these patients will be symptomatic without objective findings to explain these symptoms. The purpose of this review is to highlight potential non-surgical factors that may proceed to a poor symptomatic outcome after antireflux surgery. These factors include underlying esophageal pathophysiology, issues related to chronic pain and pain perception, personality and psychoemotional disorders, functional esophageal and/or bowel disorders, and the nocebo phenomenon. Awareness of these other causes can lead to more appropriate treatments.

The effects of staging laparoscopy on trocar site and peritoneal recurrence of pancreatic cancer.

BACKGROUND: Staging laparoscopy (SL) has been used to assess resectability of patients with pancreatic cancer. It has lead to increased resectability rates and decreased morbidity. However, experimental data suggests that laparoscopy and peritoneal insufflation can promote tumor growth and potential recurrence. Few clinical data exist to allow assessment of whether these theoretical concerns translate into clinical problems. The purpose of this study was to determine if SL increases the incidence of trocar-site and peritoneal recurrence of pancreatic cancer. METHODS: A retrospective review of all patients evaluated for pancreatic cancer from 1996 to 2001, inclusive, was included in this study. Patients were divided into five groups: nonoperative management (NM), SL followed by resection (SL-R), SL without resection (SL-NR), exploratory laparotomy with resection (EL-R), and exploratory laparotomy without resection (EL-NR). Patient records were assessed for postoperative occurrence of carcinomatosis and/or malignant ascites, trocar- or incisional-site recurrence, use of postoperative chemotherapy or radiation therapy, and survival. RESULTS: A total of 235 patients were included. Peritoneal progression of disease: NM 15.9%, SL 24.2%, EL 31.6% ( p = 0.03). Trocar/incisional recurrence: SL 3.0%, EL 3.9% ( p = NS). Use of chemotherapy/radiotherapy: NM 29.4%, SL-R 76.5%, SL-NR 62.5%, EL-R 69.6%, EL-NR 41.5%. Median survival (months): NM 3; SL-R 15, EL-R 10 ( p = NS); SL-NR 6, EL-NR 5 ( p = NS). CONCLUSION: SL does not increase the occurrence of trocar-site disease or peritoneal disease progression of pancreatic cancer. Patients who are found not to be resectable by SL are more likely to receive postoperative treatment. However, this does not appear to affect survival greatly. Nevertheless, avoidance of nontherapeutic laparotomy is worthwhile in these patients.

Esophagogastrectomy without pyloroplasty.

There is no consensus on the need for pyloroplasty after esophagectomy or proximal gastrectomy with an esophagogastrostomy and vagotomy. Arguments for routine pyloroplasty include prevention of postoperative delayed gastric emptying. Arguments against include prevention of postoperative dumping syndrome and bile reflux esophagitis. The purpose of this study was to assess clinical outcomes of patients undergoing esophagogastrectomy without routine pyloroplasty. All patients undergoing esophagogastrectomy or proximal gastrectomy with esophagogastrostomy from October 1996 to September 2002, inclusive were reviewed for age, gender, diagnosis, type of resection, pathology, short-term complications, long-term complications, remedial procedures performed, and postoperative gastric emptying scintigraphy. 58 patients were studied. Postoperative mortality was 6.9%, and anastomotic leak rate 12.1%. Eleven patients (19%) had symptomatic gastroparesis, two required pyloric balloon dilation and one a pyloroplasty. No patients complained of dumping symptoms; reflux requiring medical intervention occurred in seven (12.1%), and anastomotic stricture requiring dilation occurred in five (8.6%). Omitting a pyloroplasty does not lead to a high frequency of symptomatic delayed gastric emptying. Maintaining the pylorus may protect patients from dumping syndrome, and bile reflux esophagitis with its potential noxious effects on the remaining esophageal mucosa.

The impact of gastroesophageal reflux disease on quality of life.

BACKGROUND: Quality of life as a medical endpoint has become an important measure in clinical research. METHODS: In this article, we review the recent literature that has examined the impact of gastroesophageal reflux disease (GERD) and its treatment of quality of life. RESULTS: The increasing interest in measuring patients' quality of life as an outcome reflects an increasing awareness that traditional physiological endpoints often do not correlate well with patients' functional status, general well-being, and satisfaction with therapy. It has been shown that GERD has a significant impact on patients' quality of life; therefore, improvement of quality of life is one of the major goals of GERD treatment. This can be achieved by medical as well as surgical treatment. CONCLUSION: In addition to the patients' perspective, quality of life is one of the major endpoints in medical research that will help provide more selective treatment regimens for our patients.

Psychological and emotional aspects of gastroesophageal reflux disease.

A synergy exists between the psychological and physiological aspects of esophageal and other gastrointestinal symptoms. Based on a biopsychosocial model of disease, several multidisciplinary concepts of interventions in gastrointestinal disorders have been evaluated. The role of psychological factors in gastroesophageal reflux disease (GERD) has been under study. This article reviews psychological and emotional factors influencing GERD symptoms and treatment.

The quality of quality of life studies in general surgical journals.

BACKGROUND: There has been a tremendous increase in interest on quality of life in surgical research. An increase in interest does not necessarily translate into better research. This study evaluates surgical articles that claim to measure or make some conclusion on quality of life. STUDY DESIGN: All articles published in the calendar years 1996 and 1999 that purported to assess quality of life as end points or make some conclusion about quality of life were chosen for review from eight general surgical journals. Articles were assessed for use of a quality of life instrument, type of instrument, validation of the instrument, appropriateness of the instrument for the hypothesis, quality of statistical analysis, and adherence to the Gill and Feinstein criteria. RESULTS: Of the 18 articles published in 1996, 72% used a quality of life instrument. Eighteen instruments were used in 13 studies: 7 generic, 10 disease-specific, and 1 ad hoc. Forty-three percent were validated, 39% were appropriate for the study hypothesis, 39% had correct statistical analysis. The majority did not meet the Gill and Feinstein criteria. Of the 24 studies published in 1999, 63% used a quality of life instrument. Twenty-two instruments were used in 15 studies: 11 generic, 5 disease-specific, and 6 ad hoc. Fifty-five percent were validated, 45% were appropriate, 45% had correct statistical analysis. Once again, the majority did not meet the Gill and Feinstein criteria. CONCLUSIONS: Despite the emphasis on quality of life outcomes, a substantial number of studies made errors in conceptually defining quality of life and in use of quality of life instruments. Researchers and journal reviewers need to be better versed on the techniques of quality of life research.

Heller myotomy for achalasia: quality of life comparison of laparoscopic and open approaches.

BACKGROUND: Achalasia is a relatively rare disorder with a variety of treatment options. Although laparoscopic Heller myotomy has become the surgical treatment of choice, little data exist on the overall quality of life of patients undergoing this technique versus standard open approaches. METHODS: We prospectively evaluated all patients surgically treated for achalasia by a single surgeon. Laparoscopic Heller myotomy consisted of a long (> or = 6 cm) esophageal cardiomyotomy extending at least 2 cm onto the gastric cardia, with a concomitant Dor fundoplication. Patients were evaluated preoperatively and postoperatively for symptoms and quality of life using the SF-36, a standardized, generic quality of life instrument. RESULTS: A total of 23 patients were surgically treated: 15 patients had a planned laparoscopic procedure, with 3 conversions; 8 had planned open procedures. Dysphagia resolved in 20 of 21 patients, with 1 patient in the laparoscopic group requiring reoperation due to an inadequate gastric myotomy. Compared with preoperative scores, a statistically significant improvement occurred in the general health domain of the SF-36 (70 to 82, P = 0.04). Compared with that in patients undergoing open surgery, the laparoscopic group had better scores in the domains of physical functioning and bodily pain. CONCLUSIONS: Laparoscopic Heller myotomy has comparable success to open Heller myotomy, and causes less early detriment to quality of life. This should be the primary treatment in all fit surgical patients with achalasia.

Psychiatric disorders affect outcomes of antireflux operations for gastroesophageal reflux disease.

BACKGROUND: Most of the information used to determine a patient's candidacy for antireflux surgery has centered on physiologic measurements of esophageal functioning and quantitative assessment of acid reflux. Unfortunately, little attention has been paid to the study of psychosocial factors that could affect outcomes. The purpose of this study was to establish whether concomitant psychiatric disorders might affect the symptomatic outcomes of antireflux surgery. METHODS: We retrospectively reviewed a prospectively gathered database of patients with gastroesophageal reflux disease (GERD) who underwent either open or laparoscopic antireflux surgery. A history of a psychiatric disorder was considered to be present if the patient had been previously diagnosed with a DSM-IV psychiatric diagnosis and was being medically treated for it. Preoperatively, patients were evaluated with the symptom severity questionnaire, the GERD-HRQL (best score 0, worst score 50). Later in the series, patients were also evaluated with the generic quality-of-life questionnaire, the SF-36 (best score 100, worst score 0). After antireflux surgery, patients completed both questionnaires 6 weeks postoperatively. RESULTS: A total of 94 patients underwent antireflux surgery. Seventy-seven of them had laparoscopic antireflux surgery (either Nissen or Toupet fundoplication), and 17 had open antireflux surgery (Nissen, Toupet, Collis-Nissen, or Belsey fundoplications). Nine patients had psychiatric disorders (five major depression, four anxiety disorders). At 6-week follow-up, 95.3% of patients without psychiatric disorders were satisfied with surgery, as compared to 11.1% of patients with psychiatric disorders (p < 0.000001). Patients satisfied with surgery had a median SF-36 mental health domain score of 76, as compared to a score of 36 for patients dissatisfied with surgery (p = 0.0002). Patients without psychiatric disorders showed improvement in the median total GERD-HRQL score from 27 preoperatively to 1 postoperatively (p < 0.000001), whereas patients with psychiatric disorders demonstrated less improvement, from 30 preoperatively to 10.5 postoperatively (p = 0.03). CONCLUSIONS: Patients with psychiatric disorders are rarely satisfied with the results of antireflux surgery. Moreover, these patients demonstrated less symptomatic relief than patients without psychiatric disorders. Patients who were dissatisfied with antireflux surgery--even those without psychiatric disorders--had lower scores on the SF-36 mental health domain. These results suggest that even patients who might otherwise be candidates for antireflux surgery may have a poor symptomatic outcome, if they also have low mental health domain scores. Antireflux surgery in patients who suffer from major depression or anxiety disorder should be approached with great trepidation.