Pepsin and oropharyngeal pH monitoring to diagnose patients with laryngopharyngeal reflux.

OBJECTIVES: The aim of this study was to compare the diagnostic accuracy of salivary pepsin with oropharyngeal pH monitoring using the Restech measurement system (Dx-pH) for the diagnosis of laryngopharyngeal reflux (LPR). STUDY DESIGN: Prospective cohort study. METHODS: Seventy patients with primary symptoms related to LPR underwent gastroscopy, high-resolution manometry, pH throughout 24-hour monitoring (MII-pH), and barium esophagography between October 2015 and May 2018. In addition, an ear, nose, and throat examination was performed, including assessment of Belafsky Reflux Finding Score (RFS). Clinical symptoms were evaluated with the Belafsky Reflux Symptom Index (RSI) and the Gastrointestinal Quality of Life Index (GIQLI). Simultaneous to MII-pH, pepsin determination and Dx-pH were performed. RESULTS: Of 70 patients, 41 (58.6%) subjects with a pathological DeMeester score showed higher mean values of pepsin (mean value: 216 ng/mL, 95% confidence interval [CI]: 172 to 260), compared to patients with a normal DeMeester score (mean value: 161 ng/mL, 95% CI: 115 to 207). Salivary pepsin showed a specificity of 86.2% and sensitivity of 41.5% for diagnosing LPR using the optimal cutoff value of 216 ng/mL. Furthermore, a significant correlation between the values of salivary pepsin and the RSI score was seen in patients with pathological results in MII-pH (r = 0.344; P = 0.046). However, elevated Dx-pH measurements showed no significant correlation with either MII-pH, RSI score, RFS score, or GIQLI score, or with the results of pepsin measurement. CONCLUSION: Pepsin measurement in saliva could be an alternative tool to assist office-based diagnosis of LPR, whereas Dx-pH does not seem to be an adequate test. LEVEL OF EVIDENCE: 2B Laryngoscope, 130:1780-1786, 2020.

Perioperative chemotherapy versus neoadjuvant chemoradiation for patients with adenocarcinoma of the distal esophagus in Austria: a retrospective analysis.

BACKGROUND: The aim of this study was to compare the outcome of patients with adenocarcinoma of the distal esophagus (AEG type I) treated with neoadjuvant chemoradiation or perioperative chemotherapy. METHODS: Eligible patients from four Austrian centers were selected to conduct a retrospective analysis. All patients treated between January 2007 and October 2017 with chemotherapy according to EOX-protocol (Epirubicin, Oxaliplatin, Xeloda) or chemoradiation according to CROSS-protocol (carboplatin/paclitaxel + RTX 41.4 Gy), before esophagectomy were included. Primary outcomes disease-free survival (DFS) and overall survival (OS) as well as secondary outcomes downstaging of T- or N-stage and achievement of pathological complete response pCR (ypT0N0M0) were analyzed. Data of 119 patients were included. RESULTS: Complete data was available in 104 patients, 53 patients in the chemoradiation group and 51 patients in the chemotherapy group. The mean number of lymph nodes removed was significantly higher in the EOX group (EOX 29 ± 15.5 vs. CROSS 22 ± 8.8; p < 0.05). Median follow-up in the CROSS group was 17 months (CI 95% 8.8-25.2) and in the EOX group 37 months (CI 95% 26.5-47.5). In the chemotherapy group, the OS rate after half a year, - 1, and 3 years was 92%, 75%, and 51%. After chemoradiation, overall survival after half a year was 85 %, after 1 year 66%, and after 3 years 17%. In the EOX group DFS after ½, - 1, and 3 years was 90%, 73%, and 45%, in the chemoradiation group after half a year 81%, after 1 year 55% and after 3 years 15%. Pathological complete response (pCR) was achieved in 23% of patients after CROSS and in 10% after EOX (p < 0.000). CONCLUSIONS: There seem to be clear advantages for chemoradiation, concerning the major response of the primary tumor, whereas a tendency in favor for chemotherapy is seen in regards to systemic tumor control. Furthermore, the type of neoadjuvant treatment has a significant influence on the number of lymph nodes resected.

Clinical feasibility of a new full-thickness endoscopic plication device (GERDx™) for patients with GERD: results of a prospective trial.

BACKGROUND: Previous studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL). METHODS: Prospective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II-III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.) RESULTS: There were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication. CONCLUSIONS: Endoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.

A proposal for a tailored approach to diverting ostomy for colorectal anastomosis.

BACKGROUND: The use of a protective stoma represents an important issue in colorectal surgery. Although evidence suggests that loop ileostomy may be superior, the optimal method for temporary decompression of colorectal anastomosis still remains controversial. Aim of this study was to make an evidence-based proposal for a tailored approach to the use of diverting colostomy or ileostomy. METHODS: A retrospective analysis of all patients subjected to creation and closure of a diverting loop colostomy or loop ileostomy between May 2007 and November 2014 in our institution was performed. Early and late complications, mortality and morbidity, time between formation and closure of the stoma in respect to adjuvant chemotherapy and the length of hospital stay were assessed and compared between the two groups. RESULTS: Outcomes of 167 patients (m=95; f=72) undergoing a loop colostomy (N.=130) or ileostomy (N.=37) were analyzed. The most frequent diagnosis was malignancy (64.1%), followed by abdominal emergency operations (18.6%) and complicated diverticular disease (17.4%). There was no mortality. Adjuvant chemotherapy (26.3%) resulted in delayed stoma reversal (P<0.001). Complications following construction of the stoma such as electrolyte disorder (P<0.001), renal insufficiency (P=0.048), and skin irritation (P=0.003) occurred significantly more often within the ileostomy group. Within the colostomy group, the rate of stoma prolapse (P=0.074) tended to be higher. CONCLUSIONS: Both methods have advantages and disadvantages. Loop transverse colostomy could be the preferred technique for older patients to avoid electrolyte disorder and renal insufficiency. Further prospective trials with documentation of electrolyte metabolism and quality of life should follow.

Role of Pepsin and Oropharyngeal pH-Monitoring to Assess the Postoperative Outcome of Patients with Laryngopharyngeal Reflux: Results of a Pilot Trial.

BACKGROUND: The aim of this study was to evaluate the value of salivary pepsin and oropharyngeal pH-monitoring to assess the surgical outcome of patients with laryngopharyngeal reflux (LPR). MATERIALS AND METHODS: Twenty consecutive patients with LPR despite proton pump inhibitor treatment received laparoscopic antireflux surgery. Twenty-four hour esophageal pH-monitoring (multichannel intraluminal impedance monitoring [MII]-pH) and esophageal manometry (high-resolution manometry) data were documented preoperatively and at 3-month follow-up. An ears, nose and throat (ENT) examination was performed, including assessment of Belafsky Reflux Finding Score (RFS). Clinical symptoms were evaluated with the Belafsky Reflux Symptom Index (RSI) and the Gastrointestinal Quality of Life Index (GIQLI). Simultaneous to the MII-pH and collection of saliva samples, detection of oropharyngeal reflux events was performed. Treatment failure was defined as postoperative pathologic RFS or RSI score and improvement of GIQLI of <10 points, despite showing a normal DeMeester score. RESULTS: At baseline, all patients had a pathological ENT examination, RSI score, and MII-pH data. All patients showed postoperatively a normal DeMeester score (mean 6.39 ± 4.87). Five patients were defined as treatment failures with a change of pepsin concentration from median 157.0 (95% confidence interval [CI]: 0-422) to 180.7 (95% CI: 0-500). In patients defined as treatment success, median pepsin value decreased from 206.3 (95% CI: 89-278) to 76.0 (95% CI: 55-205); (P = .093). Oropharyngeal pH-monitoring data showed no significant change in both groups. CONCLUSION: Salivary pepsin could be a marker for treatment success, while oropharyngeal pH-monitoring seems to be inadequate in these terms. However, larger studies are required to reach firm conclusions.

Interim Report of a Prospective Trial on the Clinical Efficiency of a New Full-thickness Endoscopic Plication Device for Patients With GERD: Impact of Changed Suture Material.

BACKGROUND: The aim of the present trial is to investigate the clinical efficiency of the GERDx device for patients with gastroesophageal reflux disease (GERD). MATERIALS AND METHODS: Prospective study evaluating Gastrointestinal Quality of Life Index, symptoms scores, as well as esophageal manometry and impedance-pH-monitoring data at baseline and 3 months after endoscopic full-thickness plication with the GERDx device. RESULTS: In total, 28 patients underwent the procedure so far. Mean Gastrointestinal Quality of Life Index scores, DeMeester scores, and general and reflux-specific scores improved (P<0.01). Three of 6 patients, who were treated with converted sutures, experienced postoperative complications. CONCLUSIONS: Endoscopic plication using the GERDx device may be effective in improving quality of life and GERD symptoms. Suture length between pledgets and suture material may have an impact on procedure outcomes.

Volume and methodological quality of randomized controlled trials in laparoscopic surgery: assessment over a 10-year period.

BACKGROUND: Measures have been taken to improve methodological quality of randomized controlled trials (RCTs). This review systematically assessed the trends in volume and methodological quality of RCTs on minimally invasive surgery within a 10-year period. DATA SOURCES: RCTs on minimally invasive surgery were searched in the 10 most cited general surgical journals and the 5 most cited journals of laparoscopic interest for the years 2002 and 2012. Bibliometric and methodological quality components were abstracted using the Scottish Intercollegiate Guidelines Network. The pooled number of RCTs from low-contribution regions demonstrated an increasing proportion of the total published RCTs, compensating for a concomitant decrease of the respective contributions from Europe and North America. International collaborations were more frequent in 2012. Acceptable or high quality RCTs accounted for 37.9% and 54.4% of RCTs published in 2002 and 2012, respectively. Components of external validity were poorly reported. CONCLUSIONS: Both the volume and the reporting quality of laparoscopic RCTs have increased from 2002 to 2012, but there seems to be ample room for improvement of methodological quality.

Laparoscopic augmentation of the diaphragmatic hiatus with biologic mesh versus suture repair: a systematic review and meta-analysis.

PURPOSE: Laparoscopic repair of large hiatal hernias is associated with high recurrence rates. Erosion and mesh migration are rare but devastating complications of synthetic mesh repair, whereas reoperation is accompanied by significant operative morbidity. The aim of this study was to estimate the comparative risk of hernia recurrence following primary suture or biologic mesh repair. METHODS: A systematic literature search of the MEDLINE database was performed and comparative data of relevant studies were combined using the Mantel-Haenszel meta-analysis model. The odds ratio (OR) for hernia recurrence with 95 % confidence interval (CI) was calculated. RESULTS: Five relevant studies (two randomized controlled trials and three case-control studies) and one follow-up report of a randomized trial, encompassing 295 patients, were identified. Small intestine submucosa and human acellular cadaveric dermis were used as mesh grafts. Short-term recurrence rates were 16.6 and 3.5 % for suture repair and biologic mesh repair, respectively (OR 3.74, 95 % CI 1.55-8.98, p = 0.003). Long-term recurrence based on data provided by one trial only was 51.3 and 42.4 %, respectively (OR 1.43, 95 % CI 0.56-3.63, p = 0.45). Sensitivity analysis of the two randomized trials at short-term follow up demonstrated no significant difference (OR 2.54, 95 % CI 0.92-7.02, p = 0.07). CONCLUSIONS: Biologic mesh repair of large hiatal hernias may confer short-term benefits in terms of hernia recurrence; however, the limited available information does not allow us to make conclusions about the long-term efficacy of biologic mesh in this setting. Individual biologic mesh grafts require further clinical assessment.

Comparison of 231 patients receiving either "pull-through" or "push" percutaneous endoscopic gastrostomy.

BACKGROUND: A percutaneous endoscopic gastrostomy (PEG) can be performed as a direct stomach puncture, known as Seldinger technique ("push") or a thread pulling method ("pull"). The aim of this study was to compare the final results deriving from both application methods. METHODS: Data of all pull-through-PEG and push-PEG applications, which had been carried out in our department from 2009 to 2012, were analyzed and compared retrospectively. Data collection included patients' demographics, indications, comorbidities, peri-interventional chemotherapy, and/or radiotherapy. The complications were graded according to the Clavien-Dindo classification and divided in early- and late-term complications (before and after 10 days after PEG insertion). RESULTS: A total of 231 patients received a PEG. Of these, 131 (56.7 %) were treated with pull-through-PEGs and 100 (43.3 %) with the push-PEG method. Overall, in 61 of 231 (26.4 %) patients, a complication was documented and 37 of 61 (60.6 %) were assigned to Clavien-Dindo grade 1. Only 5 of 231 patients (2.2 %) required a re-intervention or surgical treatment under general anesthesia. The overall complication rate was significantly increased by the type of push-PEG tube used (push 33/100 = 33 vs. pull 28/131 = 21.4 %, p = 0.047). A dislocation of the tube was noticed in 5/131 (3.8 %) cases of pull-PEGs and 12/100 (12 %) cases of push PEGs (p = 0.018). An occlusion of the PEG also occurred significantly more frequent in connection with the push-PEG (10/100 = 10 vs. 1/131 = 0.8 %; p < 0.001). CONCLUSION: Both PEG techniques are safe and well established. Push PEG showed a significantly higher rate of overall complications, dislocations, and occlusions. The decision which PEG tube should be used depends on individual conditions with preference of push-PEGs in patients with head, neck, and esophageal cancer.

Meta-analysis of laparoscopic vs open cholecystectomy in elderly patients.

AIM: To investigate the comparative effect of laparoscopic and open cholecystectomy in elderly patients. METHODS: Laparoscopic cholecystectomy has induced a revolution in the treatment of gallbladder disease. Nevertheless, surgeons have been reluctant to implement the concepts of minimally invasive surgery in older patients. A systematic review of Medline was embarked on, up to June 2013. Studies which provided outcome data on patients aged 65 years or older, subjected to laparoscopic or open cholecystectomy were considered. Mortality, morbidity, cardiac and pulmonary complications were the outcome measures of treatment effect. The methodological quality of selected studies was appraised using valid assessment tools. Τhe random-effects model was applied to synthesize outcome data. RESULTS: Out of a total of 337 records, thirteen articles (2 randomized and 11 observational studies) reporting on the outcome of 101559 patients (48195 in the laparoscopic and 53364 in the open treatment group, respectively) were identified. Odds ratios (OR) were constantly in favor of laparoscopic surgery, in terms of mortality (1.0% vs 4.4%, OR = 0.24, 95%CI: 0.17-0.35, P < 0.00001), morbidity (11.5% vs 21.3%, OR = 0.44, 95%CI: 0.33-0.59, P < 0.00001), cardiac (0.6% vs 1.2%, OR = 0.55, 95%CI: 0.38-0.80, P = 0.002) and respiratory complications (2.8% vs 5.0%, OR = 0.55, 95%CI: 0.51-0.60, P < 0.00001). Critical analysis of solid study data, demonstrated a trend towards improved outcomes for the laparoscopic concept, when adjusted for age and co-morbid diseases. CONCLUSION: Further high-quality evidence is necessary to draw definite conclusions, although best-available evidence supports the selective use of laparoscopy in this patient population.

Bibliometric analysis of scientific contributions in minimally invasive general surgery.

Publication of scientific articles in peer-reviewed medical journals is considered as a measure of research productivity. The aim of the present study was to quantify the research contributions of different countries in minimally invasive surgery and to critically discuss the results under the prism of recent socioeconomic developments. The electronical archives of 4 major surgical journals (Annals of Surgery, British Journal of Surgery, Journal of the American College of Surgeons, and Surgical Endoscopy) were searched between 2009 and 2012. Publications on minimally invasive general surgery were assessed according to the country. A total of 6595 records were identified; 2160 articles were related to minimally invasive surgery. The volume of publication activity was evenly distributed in North America (34%) and Europe (39%). The United States (31%), the United Kingdom (7.6%), and Japan (6.7%) were the most productive countries. When adjusted for country population, the Netherlands (7.7/10), Denmark (4.4/10), and Switzerland (4.1/10) occupied the highest ranks. Although the United States dominates in terms of absolute number of publications, several smaller countries were more prolific, when the number of inhabitants was taken into account. The recent financial crisis is expected to undermine international collaborative conditions in the field of minimally invasive surgery. The need for a stepped-up international scientific collaboration is hereto highlighted.

Meta-analysis of randomized trials on single-incision laparoscopic versus conventional laparoscopic appendectomy.

BACKGROUND: Single-incision laparoscopic appendectomy has emerged as a less invasive alternative to conventional laparoscopic surgery. High-quality relevant evidence is limited. METHODS: A systematic review of electronic information sources was undertaken, with the objective of identifying randomized trials that compared single-incision with conventional laparoscopic appendectomy. Outcome measures included 30-day morbidity, abdominal abscess, wound infection, open conversion, reoperation, operative time, length of hospital stay, and postoperative pain. Fixed-effects and random-effects models were used to calculate combined overall effect sizes of pooled data. Data are presented as odds ratios or weighted mean differences with 95% confidence intervals (CIs). RESULTS: Five randomized trials were identified, with a total of 746 patients. Thirty-day morbidity (9.6% vs 8.6%; odds ratio, 1.14; 95% CI, .69 to 1.89) and wound infection rates were similar between single-incision and conventional laparoscopy (4.0% vs 4.8%; odds ratio, .83; 95% CI, .41 to 1.68), whereas the duration of surgery was longer in the single-incision group (46.3 vs 40.7 minutes; weighted mean difference, 6.01; 95% CI, 2.26 to 9.76). Available data were not adequately robust to reach conclusions regarding the remaining outcome measures. CONCLUSIONS: Similar postoperative morbidity and wound infection rates for single-incision and conventional laparoscopic appendectomy are supported by the current literature, but single-incision surgery requires longer operative time.

Is laparoscopic ileocecal resection a safe option for Crohn's disease? Best evidence topic.

A best evidence topic was constructed according to a structured protocol. The question addressed was whether laparoscopic ileocecal resection for Crohn's disease is associated with higher morbidity rates in comparison to open surgery. From a total of 123 articles, 11 studies provided the best available evidence on this topic. Five observational studies, two randomized trials, three follow up studies and a meta-analysis were identified. The primary author, date and country of publication, study type, patient group characteristics, relevant outcome parameters and results of these papers were tabulated. Perioperative morbidity was either similar between the laparoscopic and the open group, or favored the laparoscopic approach. Convalescence was consistently reported to be shorter in the laparoscopic treatment arm, at cost of longer duration of surgery. Limited evidence suggests lower incidence of small bowel obstruction and disease recurrence for laparoscopy, although follow up data are of poor quality. It may be concluded that laparoscopic ileocecal resection is a safe alternative approach to open surgery for uncomplicated Crohn's disease, provided laparoscopic expertise is available.

Meta-analysis of laparoscopic versus open repair of perforated peptic ulcer.

BACKGROUND AND OBJECTIVES: Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. METHODS: We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. RESULTS: Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. CONCLUSION: In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU.

Transabdominal preperitoneal versus totally extraperitoneal repair of inguinal hernia: a meta-analysis of randomized studies.

BACKGROUND: The aim of the present study was to comparatively evaluate the outcomes of laparoscopic transabdominal preperitoneal inguinal hernia repair and totally extraperitoneal repair. METHODS: The electronic databases of Medline, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, and a meta-analysis of randomized clinical trials was undertaken. RESULTS: Seven studies comprising 516 patients with 538 inguinal hernia defects were identified. A shorter recovery time (P = .02) was found for totally extraperitoneal repair in comparison with transabdominal preperitoneal inguinal hernia repair (weighted mean difference = -.29; 95% confidence interval [CI], -.71 to .07) although the length of hospitalization (P = .89) was similar in the 2 treatment arms (weighted mean difference = .01; 95% CI, -.13 to .15). Operative morbidity (P = .004) was higher for the preperitoneal approach (odds ratio = 2.15; 95% CI, 1.29 to 3.61). No differences were found with regard to the incidence of recurrence, long-term neuralgia, and operative time. CONCLUSIONS: Current evidence suggests similar operative results for endoscopic and laparoscopic inguinal hernia repair, with a trend toward higher morbidity for the preperitoneal approach. Randomized trials with a longer-term follow-up are needed in order to assess the effect of each approach on the prevention of recurrence.

A randomized trial on endoscopic full-thickness gastroplication versus laparoscopic antireflux surgery in GERD patients without hiatal hernias.

BACKGROUND AND GOALS: Endoscopic full-thickness gastroplication by the Plicator instrument has proven to be a safe and effective method to improve symptoms of gastroesophageal reflux disease. This is the first comparative objective data study for endoscopic versus laparoscopic antireflux procedures. STUDY: In this single-center controlled open trial in 70 adult patients with documented gastroesophageal reflux disease without hiatal hernias, objective and subjective outcome parameters were evaluated prospectively and compared. Patients were randomly assigned to either endoscopic full-thickness gastroplication or laparoscopic antireflux surgery. Patients in the Plicator group received between 1 and 3 transmural-pledgeted sutures to the gastric cardia. Patients in the laparoscopic anti-reflux surgery (LARS) group underwent Nissen or Toupet fundoplication. Esophageal manometry, 24-hour impedance pH monitoring, Gastrointestinal Quality-of-Life Index, and symptom questionnaires were evaluated at baseline and at the 3-month follow-up for significant (P<0.05) changes and differences. RESULTS: Lower esophageal sphincter pressures were increased in the LARS group and unchanged in the Plicator group. Total reflux numbers, acid, nonacid, proximal, upright, and recumbent reflux events were reduced in both groups, significantly more in the LARS group. Reductions in reflux-related esophageal acid scores were significant only in the LARS group. Similar improvements of Gastrointestinal Quality-of-Life Index were found in both groups. General and gas-related symptom scores were comparably reduced. Greater Reductions in reflux-specific symptom scores were found after LARS. Bowel dysfunction symptom scores were lower after LARS. CONCLUSIONS: Improvements in the general subjective outcome parameters were similar after endoscopic full-thickness gastroplication compared with LARS despite a stronger reflux control provided by LARS. More effective relief of reflux-related symptoms favors LARS, and differences in side effect symptoms favor endoscopic full-thickness gastroplication.

Blunt versus bladed trocars in laparoscopic surgery: a systematic review and meta-analysis of randomized trials.

BACKGROUND: Trocar-associated visceral injuries are rare but potentially fatal complications of laparoscopic access. More commonly, abdominal wall bleeding occurs, which usually requires hemostatic measures and prolongs operative time. Blunt-tipped trocars have been postulated to carry a lower risk of abdominal wall bleeding and intra-abdominal injuries. The aim of the present systematic review and meta-analysis was to comparatively evaluate the relative risks of abdominal wall bleeding, visceral injuries, and overall complications with the use of bladed and blunt-tipped laparoscopic trocars. METHODS: The databases of Medline, EMBASE, and the Cochrane Central Register of Randomized Trials were searched to identify randomized studies that compared trocar-associated complications with the use of blunt and bladed trocars. Primary outcome measure was the relative risk of abdominal wall trocar site bleeding, and secondary outcome measures included visceral injuries and overall complications. Outcome data were pooled and combined overall effect sizes were calculated using the fixed- or random-effects model. RESULTS: Eight eligible randomized trials were identified; they included 720 patients with a median Jadad score of 4. The incidence of abdominal wall bleeding for the blunt and the bladed trocar group was 3 and 9 %, respectively [odds ratio (OR) 0.42, 95 % confidence interval (CI) 0.21-0.88]. Trocar-associated morbidity rate, excluding bleeding events of the abdominal wall, was documented at 0.2 and 0.7 % of the blunt and the bladed trocar arm, respectively (OR 0.43, 95 % CI 0.06-2.97). The overall trocar-associated morbidity rate was 3 % in the blunt trocar group and 10 % in the bladed trocar group (OR 0.38, 95 % CI 0.19-0.77). CONCLUSIONS: Reliable data support a lower relative risk of trocar site bleeding and overall complications with blunt laparoscopic cannulas than bladed trocars. Transition to blunt trocars for secondary cannulation of the abdominal wall is thus strongly recommended. Larger patient populations are required to estimate the relative risk of visceral injuries.

Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications.

BACKGROUND: The fundoplication of choice for the surgical treatment of gastroesophageal reflux disease (GERD) still is debated. Multichannel intraluminal impedance monitoring (MII) has not been used to compare objective data, and comparative subjective data on laparoscopic Nissen and Toupet fundoplications are scarce. METHODS: This study randomly allocated 125 patients with documented chronic GERD to either laparoscopic floppy Nissen fundoplication (LNF; n = 62) or laparoscopic Toupet fundoplication (LTF; n = 63). The Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 1 year after surgery. The pre- and postprocedure data were compared. Statistical significance was set at a p value lower than 0.01 (NCT01321294). RESULTS: Both procedures resulted in significantly improved GIQLI and GERD symptoms. Preoperative dysphagia improved in both groups, but the improvement reached significance only in the LTF group. The ability to belch was shown to be significantly more decreased after LNF than after LTF. Gas-bloat and "atypical" extraesophageal symptoms also were decreased after surgery (p < 0.01). However, bowel symptoms were virtually unchanged in both groups. Both procedures resulted in significantly improved lower esophageal sphincter pressures. The improvement was greater in the LNF group than in the LTF group (p < 0.01). The DeMeester score and the numbers of total, acid, proximal, upright, and recumbent reflux episodes decreased in both groups after surgery (p < 0.01). No significant difference between the procedures in terms of MII data was found. Six patients (4.8 %) had to undergo reoperation because of intrathoracic slipping of the wrap. All the patients had undergone LNF. CONCLUSIONS: Both procedures proved to be equally effective in improving quality of life and GERD symptoms. However, the reoperation and dysphagia rates were lower and the ability to belch was higher after LTF than after LNF.

Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants.

BACKGROUND: Subjective and especially objective data after endoluminal full-thickness gastroplication are scarce. OBJECTIVE: To evaluate symptoms and reflux activity 12 months after gastroplication by using multichannel intraluminal impedance monitoring. DESIGN: Open-label, prospective, single-center study. SETTING: Tertiary referral hospital in Zell am See, Austria. PATIENTS: Subjects without hiatal hernias with documented GERD and persistent or recurrent symptoms despite treatment with a proton pump inhibitor. INTERVENTIONS: A total of 36 patients underwent endoscopic full-thickness gastroplication with 1 or more Plicator implants. MAIN OUTCOME MEASUREMENTS: Mean Gastrointestinal Quality of Life Index and reflux-specific symptom scores significantly improved on follow-up (P < .01). Atypical reflux, gas/bloating, and bowel dysfunction-specific symptom scores as well as belching and dysphagia scores improved. Twenty-two patients returned for esophageal manometry and multichannel intraluminal impedance testing 1 year after surgery. DeMeester scores decreased from 20 to 10 (P < .029). The median numbers of total, acid, proximal, upright, and recumbent reflux episodes were all significantly reduced (P < .05). Manometric data were virtually unchanged. The percentage of patients taking proton pump inhibitors on daily basis after the procedure was 11.5%. There was only 1 postprocedure incident (bleeding) that required intervention. Three of 36 patients (8.3%) were considered treatment failures because of persistent symptoms and were assigned to undergo laparoscopic fundoplication. LIMITATIONS: No randomized comparison with a sham procedure or laparoscopic fundoplication; follow-up interval. CONCLUSIONS: Endoscopic plication is safe and improves objective and subjective parameters at 1-year follow-up, without side effects seen after laparoscopic fundoplication. Further studies on the clinical merit of this procedure in specific patient populations are warranted.