Werner A. Draaisma

Five-year subjective and objective results of laparoscopic and conventional nissen fundoplication : A randomized trial

Objective:The purpose of this prospective study was to compare the subjective and objective outcome of laparoscopic (LNF) and conventional Nissen fundoplication (CNF) up to 5 years after surgery as obtained in a multicenter randomized controlled trial. Summary of Background Data:LNF is regarded as surgical treatment of first choice for refractory gastroesophageal reflux disease by many surgeons based on several short- and mid-term studies. The long-term efficacy of Nissen fundoplication, however, is still questioned as objective data gathered from prospective studies are lacking. Methods:From 1997 to 1999, 177 patients were randomized to undergo LNF or CNF. Five years after surgery, all patients were requested to fill in questionnaires and to undergo esophageal manometry and 24-hour pH-metry. Results:A total of 148 patients agreed to participate in the follow-up study: 79 patients after LNF and 69 after CNF. Of these, 97 patients (48 LNF, 49 CNF) consented to undergo esophageal manometry and 24-hour pH-metry. At 5 years follow-up, 20 patients had undergone reoperation: 12 after LNF (15%) and 8 after CNF (12%). There was no difference in subjective outcome, with overall satisfaction rates of 88% and 90%, respectively. Total esophageal acid exposure times (pH < 4) were 2.1% ± 0.5% and 2.0% ± 0.6%, respectively (P = 0.21). Antisecretory medication was taken daily in 14% and 16%, respectively (P = 0.29). There was no correlation between medication use and acid exposure and indices of symptom-reflux association (symptom index and symptom association probability). No significant differences between subjective and objective results at 3 to 6 months and results obtained at 5 years after surgery were found. Conclusions:The effects of LNF and CNF on general state of health and objective reflux control are sustained up to 5 years after surgery and the long-term results of LNF and CNF are comparable. A substantial minority of patients in both groups had a second antireflux operation or took antisecretory drugs, although the use of those medications did not appear to be related to abnormal esophageal acid exposure.

Ten-year outcome of laparoscopic and conventional nissen fundoplication: randomized clinical trial.

Objective:To compare 10 years outcome of a multicenter randomized controlled trial on laparoscopic (LNF) and conventional Nissen fundoplication (CNF), with focus on effectiveness and reoperation rate. Summary of Background Data:LNF has replaced CNF as surgical treatment for gastroesophageal reflux disease (GERD). Decisions are based on equal short-term effectiveness and reduced morbidity, but confirmation by long-term level 1 evidence is lacking. Methods:From 1997 to 1999, 177 proton pump inhibitor (PPI)-refractory GERD patients were randomized to undergo LNF or CNF. The 10 years results of surgery on reflux symptoms, general health, PPI use, and reoperation rates, are described. High-resolution manometry, 24-hour pH-impedance monitoring and barium swallow were performed in symptomatic patients only. Results:A total of 148 patients (79 LNF, 69 CNF) participated in this 10-year follow-up study. GERD symptoms were relieved in 92.4% and 90.7% (NS) after LNF and CNF, respectively. Severity of heartburn and dysphagia were similar, but slightly more patients had relief of regurgitation after LNF (98.7% vs. 91.0%; P = 0.030). The percentage of patients using PPIs slowly increased with time in both groups to 26.6% for LNF and 22.4% for CNF (NS). General health (74.7% vs. 72.7%; NS) and quality of life (visual analogue scale score: 65.3 vs. 61.4; NS) improved similarly in both groups. The percentage of patients who would have opted for surgery again was similar as well (78.5% vs. 72.7%; NS). Twice as many patients underwent reoperation after CNF compared with LNF (12 [15.2%] vs. 24 [34.8%]; P = 0.006), including a higher number of incisional hernia corrections (2 vs. 9; P = 0.015). Mean interval between operation and reintervention was longer after CNF (22.9 vs. 50.6 months; P = 0.047). Of the patients who were dependent on daily PPI therapy at 10 years (LNF 10, CNF 10), 7 patients (LNF 3, CNF 4) had recurrent GERD on pH-impedance monitoring, 5 of them with some form of anatomic recurrence. A total of 13 of 20 (65.0%) patients did not have recurrent GERD. Fourteen patients had an abnormal high-resolution manometry. Conclusions:CNF carries a higher risk for surgical reintervention compared with LNF, mainly due to incisional hernia corrections. The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms, PPI use, quality of life, and objective reflux control. Consequently, the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD.

First experience with robot-assisted thoracoscopic esophagolymphadenectomy for esophageal cancer.

BackgroundTransthoracic esophagectomy with extended lymph node dissection is associated with higher morbidity rates than transhiatal esophagectomy. This morbidity rate could be reduced by the use of minimally invasive techniques. The feasibility of robot-assisted thoracoscopic esophagectomy (RTE) with mediastinal lymphadenectomy was assessed prospectively.MethodsThis study investigated 21 consecutive patients with esophageal cancer who underwent RTE using the Da Vinci™ robotic system. Continuity was restored with a gastric conduit and a cervical anastomosis.ResultsA total of 18 (86%) procedures were completed thoracoscopically. The operating time for the thoracoscopic phase was 180 min (range, 120–240 min), and the median blood loss was 400 ml (range, 150–700 ml). A median of 20 (range, 9–30) lymph nodes were retrieved. The median intensive care unit stay was 4 days (range, 1–129 days), and the hospital stay was 18 days (range, 11–182 days). Pulmonary complications occurred in 10 patients (48%), and one patient (5%) died of a tracheoneoesophageal fistula.ConclusionsIn this initial experience, robot-assisted thoracoscopic esophagectomy was found to be feasible, providing an effective lymphadenectomy with low blood loss. Standardization of the technique and increased experience should reduce the complication rate, which is in the range of the rate for open transthoracic dissection.

Controversies in paraesophageal hernia repair; a review of literature

BackgroundThe surgical repair of paraesophageal hiatal hernias (PHH) can be performed by endoscopic means, but the procedure is not standardized and results have not been evaluated systematically so far. The aim of this review article was to clarify controversial subjects on the surgical approach and technique, i.e., recurrence rate after conventional versus laparoscopic PHH treatment, results of mesh reinforcement of the cruroplasty, the necessity for additional antireflux surgery, and indications for an esophageal lengthening procedure.MethodsAn electronic Medline search was performed to identify all publications reporting on laparoscopic and conventional PHH surgery. The computer search was followed by additional hand searches in books, journals, and related articles. All types of publications were evaluated because of a lack of high-level evidence studies such as randomized controlled trials. Critical analysis followed for all articles describing a study population of >10 patients and those reporting postoperative outcome.ResultsA total of 32 publications were reviewed. Randomized controlled trials comparing laparoscopic and open techniques could not be identified. Nineteen of the publications described the results of retrospective series. Therefore, most of the studies retrieved were low in hierarchy of evidence (level II-c or lower). The overall median hospital time as published was 3 days for patients operated laparoscopically and 10 days in the conventional group. Postoperative complications, such as pneumonia, thrombosis, hemorrhage, and urinary and wound tract infections, appeared to be more frequent after conventional surgery. Follow-up was longer for conventional surgery (median 45 months versus 17.5 months after the laparoscopic technique). Recurrence rates reported were higher in patients operated conventionally (median 9.1% versus 7.0% for patients operated laparoscopically). Recurrences after PHH repair may decrease with usage of mesh in the hiatus, although uniform criteria for this procedure are lacking. No conclusions could be drawn regarding the necessity for an additional antireflux procedure. Furthermore, uniform specific indications for the need of an esophageal lengthening procedure or preoperative assessment methods for shortened esophagus could not be detected.ConclusionTreatment based on standardized protocols for preoperative assessment and postoperative follow-up is required to clarify the current controversies.

Mechanisms of acid, weakly acidic and gas reflux after anti-reflux surgery

Background: Whereas it is well documented that fundoplication reduces acid reflux, the effects of the procedure on non-acid and gas reflux and the mechanisms through which this is achieved have not been fully elucidated. Methods: In 14 patients, reflux was measured with impedance–pH monitoring during a postprandial 90 min stationary recording period before and 3 months after fundoplication. Concomitantly, the occurrence of transient lower oesophageal sphincter relaxations (TLOSRs) and morphology of the oesophagogastric junction were studied with high-resolution manometry. This was followed by 24 h ambulatory impedance–pH monitoring. Results: Before fundoplication, two separate high-pressure zones (hernia profile) were detected during 24.9% of total time, during which there was a large increase in reflux rate. After fundoplication, the hernia profile did not occur. Fundoplication decreased the number of TLOSRs (from 10.5 (SEM 1.2) to 4.5 (0.7), p<0.01) and also the percentage of TLOSRs associated with acidic or weakly acidic reflux (from 72.7% to 4.1%, p<0.01). Nadir pressure during TLOSRs increased after surgery (from 0 (0–0) to 1.0 (1–2) kPa, p<0.05). In the ambulatory study, there was a large decrease in prevalence of both acid (−96%, from 47.0 (5.9) to 1.8 (0.5), p<0.01) and weakly acidic reflux (−92%, from 25.0 (9.7) to 2.3 (0.9), p<0.01). The decrease in gas reflux was less pronounced (−53%, from 24.2 (4.9) to 11.3 (3.0), p<0.01). Conclusions: Fundoplication greatly reduces both acid and weakly acidic liquid reflux; gas reflux is reduced to a lesser extent. Three mechanisms play a role: (1) abolition of the double high-pressure zone profile (hiatal hernia); (2) reduced incidence of TLOSRs; and (3) decreased percentage of TLOSRs associated with reflux.

Robot-Assisted Endoscopic Surgery: A Four-Year Single-Center Experience

Background: Robotic systems were introduced in the late 1990s with the objective to overcome the technical limitations of endoscopic surgery. In this prospective cohort study the potential safety, feasibility, pitfalls and challenges of robotic systems in gastrointestinal endoscopic surgery are assessed and our vision on future perspectives is presented. Methods:Between August 2000 and December 2004, 208 procedures were performed with support of the Intuitive Surgical da Vinci™ robotic system. We started with cholecystectomies (40) and Nissen fundoplications (41) to gain experience with robot-assisted surgery. In the following years more complex procedures were carried out, i.e. colorectal procedures (7), type III/IV paraesophageal hernia repair (32), redo Nissen fundoplications (9), Heller myotomies (24), esophageal resections (22), rectopexies (16) and aortobifemoral bypasses (3). Results:The median robotic set-up time was 13 min, and 7 min in the last 50 procedures. The median operating time for the total of procedures was 120 min (45–420) and the median blood loss was 30 ml (0–800). Fourteen procedures were converted to open surgery (6.7%). Equipment-related problems, such as start-up failures and positioning difficulties of the robotic arms, were encountered in 11 cases (5.3%). Postoperative complications were seen in 11 patients (11/176, 6.3%) after robot-assisted laparoscopic procedures. Pulmonary complications occurred in 11 patients, cardiac in 3, anastomic leakage in 3, chylous leakage in 3 and vocal cord paralysis in 3 after thoracoscopic esophagolymphadenectomy for esophageal cancer. One patient died 12 days after esophageal resection (0.5%). Conclusion:During the implementation of this robotic system, we experienced an obvious learning curve, particularly with regard to the positioning of the robot cart and communication between the surgeon and operating team. After 4 years, we have experienced that the merits of the current generation of this technology probably is preserved to complex endoscopic procedures with delicate dissection and suturing. In the nearby future we will focus on the treatment of motility disorders and malignancies of the esophagus and stomach. The position of the robot in the endoscopic operating room will have to be clarified by the outcome of prospective research. Furthermore, priorities have to be acclaimed on technical sophistication and cost reduction of these systems.

Laparoscopic ventral rectopexy for rectal prolapse and symptomatic rectocele: an analysis of 245 consecutive patients.

This retrospective study aimed to determine functional results of laparoscopic ventral rectopexy (LVR) for rectal prolapse (RP) and symptomatic rectoceles in a large cohort of patients.

Oesophageal acid hypersensitivity is not a contraindication to Nissen fundoplication.

The Rome III criteria classify patients with a positive relationship between symptoms and reflux episodes but a physiological oesophageal acid exposure time as having gastro‐oesophageal reflux disease (GORD) with an acid hypersensitive oesophagus. The long‐term outcome of antireflux surgery in these patients was investigated.

Long-term outcome of Nissen fundoplication in non-erosive and erosive gastro-oesophageal reflux disease.

Non‐erosive (NERD) and erosive (ERD) gastro‐oesophageal reflux disease (GORD) show similar severity of symptoms and impact on quality of life (QoL). Prospective data on long‐term outcomes of antireflux surgery in NERD are lacking.

The Visick score: A good measure for the overall effect of antireflux surgery?

Objective. In scoring the outcome of antireflux surgery, it is extremely difficult to combine the effect on reflux symptoms and esophageal acid exposure in one and the same single system – the Visick score revisited. The aim of this study was to correlate subjective outcome variables and objective outcome variables in an attempt to come to an overall reproducible scoring system. Material and methods. From 1997 to 1999, a randomized trial was set up to compare 98 patients who had undergone laparoscopic Nissen fundoplication (LNF) with 79 patients treated with conventional Nissen fundoplication (CNF). All patients were requested to complete a questionnaire, before and 3, 6, 12, 24 and 60 months after surgery. A subgroup of 87 patients agreed to undergo objective evaluation by pH-metry. The results of all these assessments were correlated with the effect of surgery on the Visick score. Results. After LNF and CNF, 79 and 69 patients, respectively, completed the questionnaires. After 5 years, complaints about heartburn, regurgitation and dysphagia were still significantly improved in the majority of patients, but in these groups, 6, 3 and 27% of patients, respectively, experienced deterioration. Visick score I or II (complaints resolved or improved) was recorded by 87% of patients. The Visick score correlated with the reduction of postoperative reflux symptom grades for heartburn, but not with the reduction of regurgitation, dysphagia and esophageal acid exposure. Conclusions. Although this study shows that the Visick score can be applied to monitor the subjective effect of primary antireflux surgery as it correlates well with the most prominent symptom of GERD (heartburn), it also underlines the difficulty in adequately scoring symptomatic outcome of antireflux surgery.