Randomized clinical trial and follow-up study of cost-effectiveness of laparoscopic versus conventional Nissen fundoplication.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) has essentially replaced its conventional open counterpart (CNF). An economic evaluation of LNF compared with CNF based on prospective data with adequate follow-up is lacking. METHODS: Data from two consecutive studies (a randomized clinical trial (RCT) of 57 patients undergoing LNF and 46 undergoing CNF that was terminated prematurely, and a follow-up study of 121 consecutive patients with LNF) were combined to determine incremental cost-effectiveness 1 year after surgery. RESULTS: Mean operating time, reoperation rate and hospital costs of LNF were lower in the second series. The mean overall hospital cost per patient was euro 9126 for LNF and euro 6989 for CNF at 1 year in the initial RCT, and euro 7782 in the second LNF series. The success rate of both LNF and CNF at 1 year was 91 per cent in the RCT, and LNF was successful in 90.1 per cent in the second series. A cost reduction of euro 998 for LNF would cancel out the cost advantage of CNF. Similarly, if the reoperation rate after LNF decreased from 0.05 to below 0.008 and/or if the mean duration of sick leave after LNF was reduced from 67.2 to less than 61.1 days, the procedure would become less expensive than CNF. Complications, reoperation rate and quality of life after both operations were similar. CONCLUSION: Including reinterventions, the outcome at 1 year after LNF and CNF was similar. In a well organized setting with appropriate expertise, the cost advantage of CNF may be neutralized.

Impact of anatomical wrap position on the outcome of Nissen fundoplication.

BACKGROUND: The importance of anatomical reposition and fixation of the type I hiatal hernia during antireflux surgery has often been emphasized. It is not known whether the initial anatomical repair withstands the test of time and whether this repair is necessary for a successful outcome. METHODS: The relationship between the objective anatomical and subjective symptomatic outcome of Nissen fundoplication was investigated prospectively in 57 patients. Findings of herniation, telescoping and obstruction at the level of the lower oesophageal sphincter on barium swallow were scored 2 years after operation by investigators who were unaware of the symptoms, and were related to symptoms and patient satisfaction evaluated by a standard questionnaire. RESULTS: According to strict criteria, some 55 per cent of patients had some degree of anatomical failure; if only complete herniation, significant telescoping and signs of obstruction were scored as abnormal, 27 per cent had anatomical failure. There was no relation to subjective outcome; relief was reported by 48 of 49 patients, 25 of whom were cured and 23 significantly improved. CONCLUSION: Anatomical repair during antireflux surgery does not stand the test of time. Although this has no demonstrable influence on the subjective outcome, the authors do not recommend deviating from well designed surgical guidelines. Current theories on the mechanism of antireflux surgery require further evaluation.

Elicitation of transient lower oesophageal sphincter relaxations in response to gastric distension and meal ingestion.

The aim of this study was to compare the effect of graded gastric barostat distension and meal-induced fundic relaxation on the elicitation of transient lower oesophageal sphincter relaxation (TLOSR). In 15 healthy subjects, stepwise fundic distension and oesophageal manometry were performed simultaneously. Next, the effect of meal ingestion on proximal stomach volume and lower oesophageal sphincter function was studied. During stepwise barostat distension of the proximal stomach, a significant linear correlation between intragastric pressure (r = 0.91; P < 0.01) and the TLOSR rate during inflation and subsequent deflation (r = 0.96; P < 0.01) was found. A similar relationship was found for volume. In addition, after meal ingestion, the TLOSR rate increased significantly from 1.40 +/- 3 to 5.4 +/- 1.5 h-1 (P < 0.01) and 5.2 +/- 1.7 h-1 (P < 0.01), respectively, during the first and second 30-min postprandially. However, at similar calculated intragastric volumes, barostat distension led to a significantly higher TLOSR rate than the meal. Similarly, distension-induced increase in gastric wall tension, estimated from the measured bag pressure and volume using Laplace's law, was associated with significantly higher TLOSR rates (P < 0.01). In conclusion, the rate of TLOSRs in healthy volunteers is directly related to the degree of proximal gastric distension and pressure-controlled barostat distension is a more potent trigger of TLOSRs than a meal. The latter finding suggests that tension receptor activation is an important stimulus for TLOSRs.

Impact of delayed gastric emptying on the outcome of antireflux surgery.

OBJECTIVE: To study the effect of Nissen fundoplication on the pattern of gastric emptying and intragastric distribution of symptoms in patients with normal and delayed gastric emptying before surgery, especially in those with delayed emptying before surgery. SUMMARY BACKGROUND DATA: Gastroesophageal reflux disease is associated with delayed gastric emptying and dyspeptic symptoms in approximately 40% of the patients. After Nissen fundoplication, dyspeptic symptoms are also not uncommon. METHODS: Thirty-six patients (26 men, 10 women, mean age 43.1) were studied before and 3 months after Nissen fundoplication. Gastric emptying (dual-isotope, expressed in lag phase, emptying rate, T50, and intragastric distribution) was not included in the decision for surgery. Reflux-related and dyspeptic symptoms were scored before and at 3, 6, and 12 months after surgery. RESULTS: Twenty-six patients had normal and 10 had delayed gastric emptying before surgery. Nissen fundoplication on average enhanced gastric emptying for solids in both subgroups by a combination of a decrease in mean lag phase, emptying rate, and T50. The preoperative difference in intragastric distribution between patients with and without delayed gastric emptying was abolished by fundoplication. Patients with normal gastric emptying before surgery showed an increase in early postprandial satiety; in those with delayed emptying, this was not observed. A correlation was found between preoperative T50 for liquid gastric emptying and postoperative nausea at 3 months in patients with normal gastric emptying. In patients with delayed emptying, preoperative correlations between lag phase for liquids and nausea respectively early satiety were significant, as well as for T50 for liquids and vomiting. CONCLUSIONS: Nissen fundoplication equalizes the preoperative difference in intragastric distribution and accelerates gastric emptying without an effect on symptoms in patients with preexisting delayed gastric emptying, but with an increase in early satiety in patients with normal gastric emptying. Delayed gastric emptying is not a contraindication for antireflux surgery.

Analysis and surgical treatment of persistent dysphagia after Nissen fundoplication.

BACKGROUND: After Nissen fundoplication, troublesome dysphagia develops in 5-10 per cent of patients. The mechanism of dysphagia has not been fully resolved, in spite of a number of studies focusing on oesophageal motility and lower oesophageal sphincter (LOS) dynamics. Tightness and length of the wrap have had considerable attention, without giving a fully satisfactory explanation of the pathophysiological mechanism. METHODS: Eighteen patients with persistent dysphagia after Nissen fundoplication needing reoperation were studied. Eighteen patients, matched for age and sex, without dysphagia after Nissen fundoplication were used as controls. Reoperation consisted of conversion of a 360 degrees into a 270 degrees wrap. Barium swallow, endoscopy, oesophageal manometry and 24-h pH monitoring were performed before and after (re)operation. RESULTS: Peristaltic amplitude, velocity and duration of contraction were not significantly influenced by operation. In 16 of 18 patients with dysphagia, LOS relaxation was incomplete and the residual relaxation pressure was significantly higher than that in the group without dysphagia (P < 0.01). No correlation was found between LOS pressure and peristaltic amplitude, nor between LOS pressure and ramp pressure in the distal oesophagus. After reoperation, basal LOS pressure decreased significantly (P < 0.01) and LOS relaxation was complete in all but three patients; residual relaxation pressure decreased (P < 0.01) and was significantly lower than that after uncomplicated Nissen fundoplication. In the latter group, LOS pressure, residual relaxation pressure and ramp pressure increased significantly after operation (P < 0.01). CONCLUSION: A return to complete LOS relaxation and a decrease in residual relaxation pressure play an important role in resolving dysphagia.

Surgical treatment for recurrent gastro-oesophageal reflux disease after failed antireflux surgery.

BACKGROUND: Recurrent or persistent symptoms occur in 10-15 per cent of patients after antireflux surgery. Failure of surgery is not uniform in its presentation. The cause of failure is not easily detected and even harder to treat. Different approaches have been proposed and few reports are available on the objective and subjective outcome of reoperation. METHODS: This study focuses on 30 patients (16 men and 14 women; age range 20-69 years) with recurrent symptomatic gastro-oesophageal reflux disease (GORD) resistant to medical treatment. In all patients reoperation was by the Belsey Mark IV antireflux operation. A clinical history, endoscopy and oesophageal manometry were obtained in all patients, and 24-h pH monitoring was performed in 27 of 30 before and in most patients after the Belsey procedure. RESULTS: Symptomatic improvement was reported in 24 of 30 patients. Oesophagitis (present before operation in 19 patients) was cured or remained absent in 24 of 30 patients, stabilized in one, improved in four and deteriorated in one. Relief of symptoms combined with absence of oesophagitis was obtained in 21 of 30 patients, with concomitant normalization of the 24-h pH profile in 11 of 22 patients. The median basal lower oesophageal sphincter (LOS) pressure increased significantly from 6. 9 to 9.0 mmHg (P < 0.01). Redo surgery had no effect on oesophageal body motility. CONCLUSION: Reoperation performed for documented recurrent GORD had a good and lasting effect on symptoms, on oesophagitis (both in 24 of 30 patients) and on the combination of both (21 of 30). In these patients reoperation increased basal LOS pressure and decreased reflux time. Overall, the results approximate to those of primary operation.

Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial. The Netherlands Antireflux Surgery Study Group.

BACKGROUND: For the surgical treatment of gastrooesophageal reflux disease (GORD), laparoscopic Nissen fundoplication has largely replaced the open procedure. Retrospective and prospective non-randomised studies have shown similar results after laparoscopic Nissen fundoplication compared with the open procedure. METHODS: In a multicentre randomised trial candidates for surgical treatment of GORD were randomly assigned to either laparoscopic or open 360 degrees Nissen fundoplication. Primary endpoints were dysphagia, recurrent GORD, and intrathoracic hernia. Secondary endpoints were effectiveness and quality of life. This planned interim analysis focuses on endpoints and complications and in-hospital costs. FINDINGS: At the time of interim analysis, 11 patients in the laparoscopic group and one in the conventional group had reached a primary endpoint (p=0.01; relative risk=8.8, 95% CI 1.2-66.3). This difference was caused mainly by whether or not patients had dysphagia (seven patients in the laparoscopic group and none in the conventional group, p=0.016). INTERPRETATION: Although laparoscopic Nissen fundoplication was as effective as the open procedure in controlling reflux, the significantly higher risk of reaching a primary endpoint in the laparoscopic group led us to stop the study.

Resistance to venous outflow during laparoscopic cholecystectomy and laparoscopic herniorrhaphy.

The effects of pneumoperitoneum on peak venous flow velocity in the common femoral vein and the vena cava have already been studied. The results suggested that venous stasis occurs during surgical pneumoperitoneum. This study determines the effects of pneumoperitoneum on the overall venous outflow resistance of the lower limbs. Venous outflow resistance was measured during surgical procedures by impedance plethysmography in 12 patients undergoing laparoscopic cholecystectomy, 4 patients undergoing laparoscopic herniorrhaphy, 4 patients undergoing conventional cholecystectomy, and 2 patients undergoing conventional herniorrhaphy. Venous outflow resistance did not change significantly during laparoscopic cholecystectomy or herniorrhaphy. No difference in venous outflow resistance between laparoscopic cholecystectomy and herniorrhaphy was found. During pneumoperitoneum, no obstruction to total lower limb venous outflow could be demonstrated, indicating that venous stasis in the limbs did not occur, and consequently, flow in the iliac and inferior caval veins was not compromised. Hypothetically, active vasodilatation resulting from mild compression may explain this. In our view, no special measures to prevent deep venous thrombosis have to be taken during laparoscopic procedures.