Open Nissen Fundoplication Research Articles

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

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. 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. 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. 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.

Pyloroplasty with Fundoplication in the Treatment of Combined Gastroesophageal Reflux Disease and Bloating

Although gastroparesis does not influence gastroesophageal reflux disease (GERD) or antireflux surgery, many patients with GERD will also suffer from gastroparesis-related bloating as a distinct symptom different from GERD-related symptoms. The purpose of this study was to assess whether a pyloroplasty with a fundoplication will improve bloating symptoms in these patients. A prospectively gathered database of all patients undergoing antireflux surgery was reviewed. All patients underwent history, physical examination, upper gastrointestinal endoscopy, esophageal manometry, 24-hour esophageal pH monitoring, and, selectively, contrast upper gastrointestinal radiography. Patients with symptoms of bloating also underwent gastric emptying scintigraphy. All patients completed the GERD-Health Related Quality of Life (HRQL) symptom severity questionnaire. One of the items of this instrument relates to bloating. The item is scored from 0 (asymptomatic) to 5 (incapacitating) based on descriptive anchors. Patients with symptomatic GERD and objective findings by physiologic testing were offered antireflux surgery. Those with delayed gastric emptying (defined as T(1/2) > 120 minutes) were also offered a pyloroplasty. Operations performed included a laparoscopic or open Nissen or Toupet fundoplication with a Heineke-Mickulicz pyloroplasty. Postoperatively, patients completed the GERD-HRQL and had a gastric emptying scintigraphy performed. Three-hundred and sixty-nine patients underwent antireflux surgery; of these, 35 patients also had a pyloroplasty. Twenty-eight (80%) of these patients reported significant symptomatic improvement. The median preoperative bloating score improved from 4 to 1 postoperatively (P < 0.05), and the median gastric emptying scintigraphy T(1/2) improved from 244 to 112 minutes (P < 0.05). Although gastroparesis may not contribute to symptoms of GERD, it can contribute to symptoms of bloating. Bloating symptoms improved in 80% of patients with the addition of a pyloroplasty. Therefore, addition of pyloroplasty to a fundoplication in patients with gastroparesis-related bloating can improve bloating symptoms.

Characterization and Management of Postoperative Hemorrhage Following Upper Retroperitoneal Laparoscopic Surgery

Surgical paradigms may change in the era of laparoscopic surgery. We evaluated a conservative nonsurgical approach to postoperative hemorrhage following laparoscopic upper retroperitoneal surgery as opposed to the more traditional strategy of reexploring the surgical site. In 911 laparoscopic procedures performed in 8 years we retrospectively identified risk factors and characterized treatment for postoperative hemorrhage. We considered postoperative hemorrhage to be present when postoperative transfusion was required that could not be accounted for by operative blood loss or another definable cause outside of the surgical field. Red blood cell transfusion was required after 53 procedures (5.8%), of which 34 (3.7%) were done for postoperative hemorrhage. Postoperative hemorrhage occurred only after nephrectomy in 3.3% of cases, after partial nephrectomy in 9.9% and after adrenalectomy in 5.4%. Multivariate analysis revealed a significant association of postoperative hemorrhage with patient age and American Society of Anesthesiologists score (preoperative factors), operative time and splenic injury (intraoperative factors), and gastrointestinal complications and prolonged hospitalization (postoperative factors). Postoperative hemorrhage increased mean hospitalization from 2.5 to 6.4 days. No significant differences in post-hospital recovery were associated with postoperative hemorrhage. Only 4 of the 34 patients (12%) required surgical management of postoperative hemorrhage. All other cases were conservatively managed. Outcome after surgical and conservative management did not differ except postoperative renal complications tended to be more common in the former cases (50% vs 7%). Most patients with hemorrhage following laparoscopic upper retroperitoneal surgery can be treated with conservative nonsurgical interventions.

Effect of Nissen Fundoplication on Gastric Motor and Sensory Functions

Bloating, abdominal pain, and early satiety have been reported in up to 30% of patients after Nissen fundoplication. We hypothesized that these postsurgical complications in children and young adults are linked to either the effects of surgery on gastric sensation, compliance or motor function or to preexisting physiological abnormalities. We prospectively evaluated the effect of Nissen fundoplication on gastric sensory and motor functions in 13 children with gastroesophageal reflux. Gastric barostat and mixed meal gastric emptying studies were performed before surgery in all patients and were repeated after surgery in 8 and 9 children, respectively. Thirteen patients (median age, 7 years; range, 6 months to 18 years) underwent open Nissen (n = 6) or laparoscopic Nissen fundoplication (n = 7). After fundoplication, patients had significantly higher minimal distending pressure values (10 mm Hg vs 3 mm Hg pre-Nissen, respectively; P < 0.001), reduced gastric compliance (slope values of 8.39 mm Hg vs 9.15 mm Hg, respectively, P < 0.001) and significantly higher pain scores (P < 0.001). Presurgery and postsurgery gastric emptying at 60, 90 and 120 minutes after feeding showed no significant changes. After Nissen fundoplication, children with gastroesophageal reflux manifest the following: (1) reduction in gastric compliance, (2) increase in minimal gastric distending pressure, (3) exacerbation of the sensations discomfort with gastric distension and (4) no effect on gastric emptying.

Quality of life and predictors of long-term outcome in patients undergoing open Nissen fundoplication for chronic gastroesophageal reflux

Background Long-term outcome of antireflux operations as well as pre- and postoperative parameters able to predict their clinical results are still controversial. The aim of the present study was to evaluate long-term quality of life of patients undergoing open fundoplication for chronic GERD and to investigate pre- and early postoperative functional parameters possibly related to persistence or recurrence of symptoms. Methods A cohort of 25 patients who underwent open Nissen fundoplications was reviewed for an evaluation of long-term residual symptoms and quality of life at an average follow-up of more than 10 years. Clinical evaluation was performed by using a symptom-specific score (DeMeester’s score), 3 health-related quality of life scores, a GERD-specific (GERD-HRQL score) score, and 2 generic scores (SF-36) evaluating physical and psychological well-being. Subjective satisfaction grade of the patients was also investigated. In addition, a univariate analysis is provided, according to the long-term presence or absence of residual symptoms (120.6-month follow-up), taking into account pre- and postoperative (6-month follow-up) data of endoscopy, 24-hour pH monitoring, stationary manometry, and gastric-emptying test. Results Persistence or recurrence of GERD-specific symptoms (heartburn and regurgitation) were reported by 8 patients (32%); 2 patients (8%) were reoperated on for persistent dysphagia, whereas 17 patients (68%) were asymptomatic. GERD-HRQL and SF-36 scores displayed significant postoperative improvement, which continued in long-term follow-up. Twenty patients (80%) had repeat fundoplication. Among tested parameters, only postoperative mean supine esophageal clearance and gastric emptying half-time, although on average improved significantly after the antireflux procedure, differed significantly in long-term asymptomatic and symptomatic subgroups. In long-term asymptomatic patients, postoperative (6 month) mean supine esophageal clearance was 0.8 ± 0.3 minutes ( P = .011) and 2.4 ± 0.2 minutes in symptomatic patients. Postoperative (6 month) mean gastric emptying half-time of long-term asymptomatic patients was 93.3 ± 8.9 minutes, whereas in symptomatic patients it was 127.5 ± 14.3 minutes ( P = .047). Conclusions Patients undergoing Nissen fundoplication had a satisfactory long-term quality of life. Clinical results did not deteriorate over time and showed to be related to postoperative esophageal clearance and gastric emptying, which could be regarded as early postoperative predictors of long-term clinical outcome.

Antireflux Surgery Outcomes in Pediatric Gastroesophageal Reflux Disease

Antireflux surgery is performed frequently in children with gastroesophageal reflux disease (GERD). Few comparative studies exist which assess the indications for and short- or long-term outcome of open Nissen fundoplication (ONF) and laparoscopic Nissen fundoplication (LNF) for pediatric GERD. We investigated the frequency of reoperation and factors that might influence its occurrence. We performed a retrospective, follow up cohort study of all children </=5 years, who underwent LNF or ONF at our institution from January 1, 1997 to December 31, 2002, where five pediatric surgeons perform fundoplication. Mean follow up time was 36.2 months. The following information was obtained: surgical indications, hospital course data, and long-term surgical outcomes. Data were analyzed using univariate and multiple logistic regressions. Overall, 456 (150 [32.9%] ONF vs. 306 [67.1%] LNF) cases were analyzed. Reoperation was performed in 55 (12.06%), LNF 43 (14.05%), and ONF 12 (8%). The mean interim to reoperation for LNF was 11 months compared to 17 months for ONF (p= 0.007). The reoperation rate at 12 and 24 months were 10.5%, 13.4% and 4%, 6.7% respectively, when LNF was compared to ONF (p= 0.01). The multivariate analysis showed that initial LNF and prematurity were the main predictors for reoperation. The majority of reoperations for both LNF and ONF occurred in the first year after initial operation; LNF had a significantly higher reoperation rate than ONF. The probability of reoperation for LNF and ONF increases with the presence of comorbidities, especially prematurity and chronic respiratory conditions.

Inflammatory response in children after laparoscopic vs open Nissen fundoplication: randomized controlled trial

We performed a randomized controlled trial to compare the inflammatory and immune responses to Nissen fundoplication in infants and children undergoing either open or laparoscopic surgery. Methods Forty children undergoing Nissen fundoplication were randomized to laparoscopy or open surgery using minimization with respect to age, neurologic status, and operating surgeon. Intraoperative and postoperative analgesias were standardized. Inflammatory markers (plasma malondialdehyde, nitrate plus nitrite level, and cytokines) and monocyte class II major histocompatibility complex expression were measured preoperatively, at end of surgery, 4, 24, and 48 hours postoperatively. Postoperative changes were compared between open and laparoscopic groups. Results There were no significant changes in circulating malondialdehyde, nitrates plus/ nitrite, interleukin-10, or tumor necrosis factor α in the postoperative period in either group. Interleukin-1 receptor antagonist (IL-1rA) and IL-6 were significantly increased in both groups, with a tendency for greater elevation of IL-1rA in the open group. Monocyte major histocompatibility complex expression fell significantly in both groups; however, this fall appeared to be slightly more marked in the open group. Conclusions The postoperative cytokine response is similar in children undergoing open and laparoscopic Nissen fundoplication. This trial indicates that laparoscopy may partly reduce postoperative immune suppression.

Ineffective oesophageal motility does not affect the clinical outcome of open Nissen fundoplication

Ineffective oesophageal motility does not affect the clinical outcome of open Nissen fundoplication

Ineffective oesophageal motility does not affect the clinical outcome of open Nissen fundoplication.

Nissen fundoplication is considered the 'gold standard' in antireflux surgery but some surgeons employ a different surgical strategy when gastro-oesophageal reflux disease (GORD) is associated with motor disorders of the oesophageal body. Ninety-three patients undergoing surgery for GORD were divided into two groups: 52 patients (group 1) had normal oesophageal body motility and 41 (group 2) had ineffective oesophageal motility (IOM). All patients had a short Nissen fundoplication via a laparotomy. The median follow-up was 5 years in group 1 and 6.5 years in group 2. The clinical outcome was satisfactory in more than 90 per cent of the patients in both groups. Only one of ten patients with IOM and dysphagia before operation still had dysphagia after surgery. One patient in each group developed postoperative dysphagia. Six of 52 patients with normal motility and eight of 41 with IOM had persistent pathological acid reflux after surgery. Significant increases in contractile wave pressure and a decrease in the percentage of non-propagated waves were found in group 2 after fundoplication. Patients with IOM did not have an increased rate of dysphagia after total fundoplication compared with those with normal motility, but they did have a higher rate of recurrence of endoscopic and pH-proven reflux.

The Effect of Chronic Pain Syndromes and Psychoemotional Disorders on Symptomatic and Quality-of-Life Outcomes of Antireflux Surgery

Psychoemotional disorders (PED) and chronic pain syndromes (CPS) are common problems. Many patients with these disorders also suffer from gastroesophageal reflux disease (GERD). It is unclear how PED/CPS affect outcomes of antireflux surgery; therefore, the purpose of this study was to determine if PED/CPS adversely affects the results of surgical therapy for GERD. All patients referred for surgical therapy for GERD completed both the GERD-HRQL symptom severity instrument and the SF-36 generic quality-of-life instrument prior to surgery. To be candidates for surgery, patients must have symptomatic GERD and objective evidence of pathologic reflux by upper endoscopy, esophageal manometry and 24-hour pH monitoring. Patients underwent either laparoscopic or open Nissen or Toupet fundoplication. Six to 24 months postoperatively, patients were evaluated for satisfaction and quality-of-life. Ninety-three percent of control patients compared to 25% of PED/CPS patients were satisfied with surgery ( P < 0.001). Dissatisfaction in PED/CPS patients was generally due to persistent or new somatic complaints. Median total GERD-HRQL scores improved for both groups, although postoperative scores were worse in the PED/CPS group. PED/CPS patients had significantly worse SF-36 scores both preoperatively and postoperatively compared to control patients. SF-36 scores improved in four of eight domains in control patients and none in the PED/CPS patients. In conclusion, PED/CPS patients are generally dissatisfied with antireflux surgery. Although some patients do benefit from surgery, careful patient selection is required. ( J Gastrointest Surg 2003;7:53–58.)

Minimally Invasive Surgical Techniques in Reoperative Surgery for Gastroesophageal Reflux Disease in Infants and Children

Fundoplication is commonly performed in children suffering from complications of gastroesophageal reflux disease (GERD). Recently laparoscopic fundoplication has become a standard of care for GERD in children. Published reports show that 2.3 to 14 per cent of children require reoperation after failed fundoplication. The purpose of this study is to show the feasibility of minimally invasive surgical (MIS) techniques to treat children after failed fundoplication. A retrospective chart review was performed for all patients who underwent laparoscopic redo fundoplication at Children's Healthcare of Atlanta at Egleston from July 1998 to July 2000. The patients' records were reviewed for age, diagnosis, type and time of initial operation, type and time of redo operation, operative time for redo operation, and complications. Seventeen children (age 3 months to 18 years) had operations for failed fundoplication attempted using MIS techniques. Six of these children were referred after their initial operation performed elsewhere. Nine (53%) were neurologically impaired. Ten (59%) have respiratory complications of GERD. The initial procedures were as follows: One open Nissen fundoplication, two open Thal fundoplications, 13 laparoscopic Nissen fundoplications, and one laparoscopic Toupet fundoplication. The reoperative procedures performed were revision of fundoplication and hiatal hernia repair (13) or hiatal hernia repair only (four). Two patients had concurrent gastric emptying procedures. One procedure was converted to open for technical reasons. One patient developed a pelvic abscess secondary to leakage around the gastrostomy tube. One child had erosion into the esophagus of a Dacron patch that was used to close a large hiatal defect. Thirteen patients began feeding by the first postoperative day. We conclude that MIS techniques can be applied to reoperative surgery for the treatment of GERD with an acceptable complication rate in this difficult group of patients. Reoperative patients appear to have the same benefits from MIS as patients undergoing their initial procedure.

Gastroesophageal Reflux Disease in Neurologically Impaired Children: The Role of the Gastrostomy Tube

We review our experience with gastrostomy techniques in neurologically impaired (NI) children, with or without a Nissen fundoplication. The records of 130 NI children who had a gastrostomy tube (GT) placed between January 1999 and October 2001 were reviewed. Data collected included: demographics, neurological status, operative time, time to first feed, postoperative stay, analgesic requirements, follow-up, mortality and complication rates. Open GTs were placed using the standard Stamm gastrostomy technique through a midline incision and were combined with a standard open Nissen fundoplication when indicated. Laparoscopic GTs were placed after institution of carbon dioxide pneumoperitoneum using a 2-port technique, a Mic-key G device of appropriate size and anchored to the anterior abdominal wall with 2 "U" stitches. The laparoscopic Nissen fundoplication (LNF) procedures were performed using a 5-port technique. Patients were divided into 4 groups: group I (n = 12) laparoscopic GT alone, group II (n = 44) open GT alone, Group III (n = 44) laparoscopic GT with LNF and Group IV (n = 30) open GT with Nissen fundoplication. Based on their similar characteristics, Groups I and II and Groups III and IV were compared together. Data were analysed using Student's t test, and internal review board approval was obtained. Patients ranged in age between 10 days and 17.7 years (mean 3.64 years). Their weight was between 1.2 and 63.4 kg (mean 12.8 kg). The compared groups showed similar characteristics with regard to age, weight, cause of mental impairment, and the reason for placement of the GT. The operative time for group III was significantly longer than that of group IV (P < 0.05). Time to first feed was significantly shorter for group I when compared to group II. The postoperative analgesic requirements were not statistically different. The overall short- and long-term complication rates were not statistically different when the related groups were compared, however, site-related complications and feeding problems were significantly less in group I compared to group II. Only 1 operative mortality occurred in group III. Follow-up showed less long-term morbidity and fewer complications with the laparoscopic GT compared to the open one as regard to admissions, surgery, and emergency department visits related to GT problems as well as frequency of GT change. Based on our experience, laparoscopic placement of a low-profile GT in NI children appears to be associated with less morbidity, permits earlier enteral nutrition, and has a cosmetic advantage. We believe that the laparoscopic technique should be the procedure of choice for GT placement in these children even when a Nissen fundoplication is deemed necessary.

Laparoscopic vs open approach for Nissen fundoplication

Several studies, most of them nonrandomized, have shown similar functional results for both laparoscopic and open Nissen fundoplication, the operation of choice for the treatment of gastroesophageal reflux disease (GERD). A total of 106 patients with documented GERD were randomized to receive either a laparoscopic or an open Nissen fundoplication. Preoperative and postoperative investigations included clinical assessment, esophagogram, upper gastrointestinal endoscopy, esophageal manometry, and 24-h ambulatory pHmetry. Both approaches were successful in controlling reflux. There was an overall improvement in esophageal peristalsis and an increase in lower esophageal sphincter (LES) pressure in both groups. Open Nissen fundoplication was associated with a significantly increased rate of wound (p <0.001) and respiratory (p <0.05) complications. Hospitalization was also longer after the open technique (p <0.001). At 3-month follow-up, although the rate of postoperative dysphagia was similar for the two approaches, the open approach was associated with a significantly higher incidence of postprandial epigastric fullness (p <0.05) and bloating syndrome (p <0.01). The open and laparoscopic approaches for the Nissen fundoplication are equally effective in controlling GERD. The open approach is associated with a significantly higher rate of wound and respiratory complications and, at early stages, an increased rate of postprandial epigastric fullness and abdominal bloating. The dysphagia rate is similar with both methods.

Comparison of laparoscopic and open Nissen fundoplication 2 years after operation

Comparison of laparoscopic and open Nissen fundoplication 2 years after operation

Effects of antireflux procedures on respiratory symptoms

Background. Antireflux surgery can reduce respiratory symptoms associated with gastroesophageal reflux. However, there is a paucity of data on the durability of this benefit. To evaluate the long-term effects of antireflux surgery on respiratory complaints associated with gastroesophageal reflux, we reviewed our experience. Methods. Retrospective review of 2,123 antireflux procedures completed between 1986 and 1998 identified 65 patients (3.1%) with associated respiratory symptoms. There were 32 men and 33 women, ranging in age from 20 to 80 years (median 59 years). Respiratory symptoms included wheezing in 43 patients, sputum production in 37, cough in 30, choking episodes in 24, and hoarseness in 17. Preoperative medication use included steroids in 23 patients and bronchodilators in 18. Results. Antireflux operations included the uncut Collis-Nissen fundoplication in 29 patients, Belsy Mark IV repair in 13, open Nissen fundoplication in 13, and laparoscopic Nissen fundoplication in 10. Perioperative complications occurred in 19 patients who underwent open procedures and in none who had laparoscopic procedures. There was one death in the open-operation group and none in the laparoscopic group. Median follow-up was 65 months (range 1 to 174 months) and was complete in 62 patients (96.9%). Improvement in respiratory symptoms (83%) and reduction in respiratory medication use (78%) were significant as compared to a calculated 33% placebo-effect improvement ( p < 0.05). Conclusions. Antireflux operations significantly reduce respiratory complaints associated with gastroesophageal reflux. This benefit appears to be long term.

Upper GI 09

Aims: This study compares the outcome of three different techniques of antireflux surgery, carried out at three regional specialist units. Methods: Patients undergoing open Nissen fundoplication (Newcastle (ON), n = 76), laparoscopic Nissen fundoplication (Edinburgh (LN), n = 119), and laparoscopic Watson fundoplication (Aberdeen (LW), n = 254) between December 1993 and February 2001 were identified from prospectively compiled databases. Patients were sent a questionnaire, including two gastrointestinal symptom scores (DeMeester and Gastrointestinal Symptom Rating Scale (GSRS)). Results: A total of 357 (80.6 per cent) patients completed questionnaires; no differences in response rate were observed among centres. Median time since surgery was 3.8 years for LW group, 2.4 years for LN group and 3.5 years for ON group (P < 0.001). Only a mean of 6.5 per cent patients reported a poor outcome. DeMeester score (GORD symptoms) was highest following LW and lowest following LN (P = 0.009), and increased with time from operation. However, logistic regression revealed no difference among the procedures after allowing for the effect of time, suggesting that time since operation is important, not procedure type. Overall, LN patients reported greater inability to belch (P = 0.007), however, this symptom also improved over time (r = −0.14, P = 0.009), and there was no difference among groups after taking time since operation into account. In addition there was no significant difference in the GSRS scores, painful bloating or inability to vomit between groups. Conclusion: This study has confirmed that the long-term outcome following all three procedures is similar with gradual reduction in inability to belch with time and some recurrence of other GORD symptoms.

One-year results of a randomised clinical trial comparing Laparoscopic with open Nissen fundoplication.

s of the Netherlands Society of Gastroenterology and the Netherlands Society of Hepatology: Spring Meeting, 15–16 March 2001

Laparoscopic Nissen fundoplication with carbon dioxide pneumoperitoneum preserves cell-mediated immunity in an immature animal model

Purpose: The aim of this study is to elucidate the effects of laparoscopic Nissen fundoplication (LNF) with carbon dioxide (CO2) or helium (He) on the cell-mediated immune response in a pediatric animal model compared with open Nissen fundoplication (ONF). Methods: Cell immune response was evaluated in 45 1-week-old Sprague Dawley rats using the delayed type hypersensitivity (DTH) skin test. Animals were sensitized against keyhole limpet hemocyanin (KLH) by subcutaneous injection (0.5 mg) in complete Freund's adjuvant. Animals were challenged 2 weeks later by an intradermal injection of KLH (0.3 mg) in sterile saline (challenge 1, baseline). Rats with positive DTH skin reaction at 24 and 48 hours after challenge 1 were put randomly into 4 groups (n = 10 each): I, only anesthesia (control); II, LNF with CO2, III, LNF with He; IV, ONF. Animals were injected intradermally with KLH (0.3 mg) immediately before the procedures (challenge 2) and 3 and 6 days postoperatively (challenges 3 and 4). Results: DTH skin reactions were measured 24 and 48 hours after each challenge. There were no significant changes in cell-mediated immunosuppression after LNF with CO2. However, a transient cell-mediated immunosuppression was observed after LNF with He and ONF. All fundoplications were intact at the time of necropsy. Conclusions: These data suggest a transient suppression of cell-mediated immunity in open procedures when compared with laparoscopic interventions using CO2 in a pediatric animal model. In addition, the type of gas used during laparoscopy also may modulate this transient immunosuppression. J Pediatr Surg 36:1564-1568. Copyright © 2001 by W.B. Saunders Company.

MD4: INCLUSION OF INDIRECT COST IN ECONOMIC OUTCOMES ANALYSES OF MEDICAL DEVICES: HOW IMPORTANT IS IT?

OBJECTIVE: To evaluate the impact of indirect cost (due to absence from work, disability, mortality) in economic evaluations comparing minimally invasive procedures using devices to conventional open surgery. Indirect cost savings benefit patients, employers and society as a whole and therefore are important costs to consider. METHODS: We searched the literature and identified studies in which “indirect cost”, “convalescence” or “work loss” were included in the analysis. All articles published since 1990 on menorrhagia (laparoscopic hysterectomy/endometrial ablation versus open hysterectomy), Gastroesophageal Reflux Disease (GERD) (laparoscopic versus open Nissen fundoplication), and coronary artery disease (Percutaneous Transluminal Coronary Angioplasty (PTCA) versus Coronary Artery Bypass Graft (CABG) surgery) were reviewed. Key information abstracted included: days of work lost, direct and indirect cost estimates, costing methodology, and follow-up period. The percentage impact, measured as the change in the difference between the total cost of open surgery compared to the less-invasive procedure due to the inclusion of indirect cost, was calculated. RESULTS: The review produced 11 articles on menorrhagia, 5 on GERD, and 5 on coronary artery disease. There were large differences in the average days of work loss between open surgery and less-invasive procedures; 21 days for laparoscopic versus 40 days for open hysterectomy, 15 days for laparoscopic versus 35 days for open fundoplication, and 27 days for PTCA versus 74 days for CABG. The percentage impact or difference in total cost due to the inclusion of indirect cost was on average 32.8% (4.4%–69.4%). CONCLUSIONS: Cost savings associated with minimally invasive surgery compared to open surgery are significantly increased when indirect costs are included in the assessment. Future economic outcome studies should attempt to include indirect cost measures to fully capture the benefits of devices and minimally invasive procedures.

What did the Laparoscopic Nissen Approach of the Gastro-oesophageal Reflux Really Change for the Patients 8 Years Later?

Background: Nissen fundoplication (NF) is recognized as the surgical treatment of the gastro-oesophageal reflux disease (GERD). NF can be achieved either by open surgery or by laparoscopic approach.Methods : From 1987 to 1997, 210 patients were treated for GERD by NF : 61 by open and 149 by laparoscopic approach. All the patients were followed more than 1 year and were scored by clinical assessment (Visick scale adaptation). In case of Visick score > 1, Gl-endoscopy, X-ray series or 24-hour pH-study complete the evaluation.Results : The operative time was comparable between both groups. The postoperative recovery was statistically faster in the laparoscopic group (p = 0.0001). The mean time of follow-up was 6 years after open NF and 4 years after laparoscopic NF. After open NF or laparoscopic NF, 72% and 67% of the patients are respectively scored Visick 1,13% and 21 % - Visick 2,6.8% and 6% -Visick 3 and 8.2% and 6% -Visick 4 (NS). Patients with recurrence of GERD were scored Visick 4, so failure of the surgical treatment is observed in 5 patients after open NF and 9 patients after laparoscopic NF. The occurrence of incisional hernia was significantly higher in the open group (p = 0.0001).Conclusion : NF remains a safe procedure for surgical treatment of GERD and can be achieved by laparoscopic approach with comparable results to those by open laparotomy. In our experience, the advantages of the laparoscopic approach is a faster postoperative recovery and a lower risk of incisional hernia.