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.

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.

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.

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.

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.

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.

Robot-assisted laparoscopic surgery of the colon and rectum.

INTRODUCTION: Laparoscopic techniques have induced a tremendous revolution in the field of general surgery. Recent multicenter trials have demonstrated similar patient-oriented and oncologic outcomes for laparoscopic colon and rectal resections compared with their open counterparts. Meanwhile, robotic technology has gradually entered the field of general surgery, allowing increased dexterity, improved operative view, and optimal ergonomics. The objective of this study was to review the current status of clinical robotic applications in colorectal surgery. METHODS: A systematic review of the literature using the PubMed search engine was undertaken to identify relevant articles. The keywords used in all possible combinations were: surgical robotics, robotic surgery, computer-assisted surgery, colectomy, sigmoid resection, sigmoidectomy, and rectal resection. RESULTS: Thirty-nine case series or comparative nonrandomized studies were identified. A specific interest for robot-assisted rectal surgery during the past few years was recorded in the literature. The retrieved articles included 13 ileocecal resections, 220 right colectomies, 190 left colectomies/sigmoid resections, 440 anterior resections, 149 abdominoperineal/intersphincteric resections, and 11 total/subtotal colectomies. The clinical application of the da Vinci robotic system in right and left/sigmoid colectomies yielded satisfactory results in terms of open conversion (1.1 and 3.8%, respectively) and operative morbidity (13.4 and 15.1%, respectively). Robot-assisted anterior resection was accompanied by a considerably low conversion rate (0.4%), morbidity (9.7%), and adequate number of harvested lymph nodes (14.3, mean). CONCLUSIONS: Robotic applications in colorectal surgery are feasible with low conversion rates and favorable morbidity. Further studies are required to evaluate its oncologic and patient-oriented outcomes.

Laparoscopic Nissen versus Toupet fundoplication: objective and subjective results of a prospective randomized trial.

BACKGROUND: Although symptom outcomes following laparoscopic fundoplication have been adequately evaluated in the past, comparative subjective data of laparoscopic Nissen and Toupet fundoplications are scarce. Multichannel intraluminal impedance monitoring (MII) has not been used so far for comparison of objective data. METHODS: One hundred patients with documented chronic gastroesophageal reflux disease (GERD) were randomly allocated to either floppy Nissen fundoplication (group I, n = 50) or Toupet fundoplication (group II, n = 50). Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 3 months after surgery. Subjective and objective outcome data were compared to those of healthy individuals. RESULTS: Symptom intensity was significantly more severe and GIQLI showed impairment in the examined patient population compared to healthy controls. Both procedures resulted in a significant improvement in GIQLI and GERD symptoms (p < 0.01). Dysphagia improved significantly only in group II, while cough, asthma, and distortion of taste improved significantly in both groups. Hoarseness symptoms showed some degree of improvement in both groups but reached statistical significance only in group I. Postoperatively, bowel symptoms partly increased and the ability to belch decreased in both groups (p < 0.05). Comparison of postoperative GIQLI and symptom scores showed no significant difference between the two groups, except for the ability to belch, which was more impaired after Nissen fundoplication. Both procedures resulted in a significant improvement in lower esophageal sphincter (LES) pressure; however, the improvement was greater in group I than in group II. MII data showed more reflux control after Nissen, but the differences between the procedures were not significant. CONCLUSIONS: Both procedures equally improve quality of life and GERD symptoms. Bowel symptoms may increase after both procedures at the 3-month follow-up. Manometry and MII data favor Nissen fundoplication, but dysphagia and the inability to belch are more common compared to Toupet fundoplication.

A comprehensive review of telementoring applications in laparoscopic general surgery.

BACKGROUND: Incorporation of advanced laparoscopic procedures in the practice of institutions without respective experience is a significant impediment in the dissemination of minimally invasive techniques. On-site mentoring programs carry several cost-related and practical constraints. Telementoring has emerged as a practical and cost-effective alternative mentoring tool. The present study aimed to review the pertinent literature on telementoring applications in laparoscopic general surgery. METHODS: A systematic review using the Medline database was performed. Articles reporting on clinical experience with telementoring applications in general surgery were included. Variations in methodology, study design, and operative procedures precluded cumulative outcome evaluation. Instead, a critical appraisal of current evidence was undertaken. RESULTS: Seventy-five articles were identified in the primary search, and ten studies were considered eligible. No randomized studies comparing on-site mentoring with telementoring were identified. The included studies reported on a total of 96 laparoscopic telementored procedures: 50 cholecystectomies, 23 colorectal resections, 7 fundoplications, 9 adrenalectomies, 6 hernia repairs, and 2 splenectomies. Completion of remotely assisted procedures was feasible in the vast majority of cases, whereas technical difficulties included video and audio latency with low transfer rates (<128 kbps) and inadequate guidance regarding the correct plane for dissection. CONCLUSION: Current evidence supports the feasibility and safety of telementoring programs in general surgery. Their clinical effectiveness as teaching alternatives to traditional mentoring programs remains to be further evaluated.

Endoscopic full-thickness plication versus laparoscopic fundoplication: a prospective study on quality of life and symptom control.

BACKGROUND: Endoscopic antireflux techniques have emerged as alternative therapies for gastroesophageal reflux disease (GERD). Endoscopic plication receives continuing interest as an effective and safe procedure. This treatment option has not been the subject of comparison with well-established operative therapies to date. The present study aimed at comparatively evaluating the effectiveness of endoscopic plication and laparoscopic fundoplication in terms of quality of life and symptom control. METHODS: Between October 2006 and April 2010, 60 patients with documented GERD were randomly assigned to undergo either endoscopic plication or laparoscopic fundoplication. Quality-of-life scores and symptom grading were recorded before treatment and at 3- and 12-month follow-up. Outcomes were compared with the statistical significance set at a p value of 0.05. RESULTS: Twenty-nine patients from the endoscopic group and 27 patients from the operative group were available at follow-up. Quality-of-life scores showed a substantial and similar increase for both groups after treatment. Symptoms of heartburn (p < 0.02), regurgitation (p < 0.004), and asthma (p = 0.03) were significantly improved in the endoscopic group, whereas laparoscopic fundoplication was more effective in controlling symptoms of heartburn (p < 0.01) and regurgitation (p < 0.05) compared to the endoscopic procedure. CONCLUSIONS: Endoscopic plication and laparoscopic fundoplication resulted in significant symptom improvement with similar quality-of-life scores in a selected patient population with GERD, whereas operative treatment was more effective in the relief of heartburn and regurgitation at the expense of higher short-term dysphagia rates.

Mesh-reinforced hiatal hernia repair: a review on the effect on postoperative dysphagia and recurrence.

PURPOSE: The objective of the present study was to review the pertinent literature and analyze the evidence for and against the use of mesh for hiatal hernia repair, with a focus on the effects on recurrence and postoperative dysphagia. METHODS: A literature search was performed between January 1990 and March 2010. Studies were considered for inclusion, provided (1) they comprised a series of at least 20 patients, (2) they documented a follow-up period of at least 6 months, (3) they reported on the outcome as expressed by hernia recurrence rates, and (4) they reported on type of mesh material, hiatal closure, and antireflux surgery. RESULTS: Twenty-three articles enrolling a cumulative number of 1,446 patients fulfilled the inclusion criteria. Polypropylene meshes seem to be associated with low recurrence rates (0-22.7%, median 1.9%) and acceptable dysphagia rates (0-21.7%, median 3.9%). Higher dysphagia rates after polytetrafluoroethylene (PTFE) and expanded PTFE (ePTFE) mesh hiatoplasty have been recorded (15.5-34.3%). Even though the use of novel biologic implants for hiatal repair is still in its infancy, the existing results from clinical research are promising. CONCLUSIONS: Polypropylene meshes seem to provide durable results with low dysphagia rates. Unacceptably high recurrence rates for PTFE/ePTFE meshes have been reported. Biologic implant engineering represents a promising field in hiatal hernia surgery.

Influence of the size of the hiatus on the rate of reherniation after laparoscopic fundoplication and refundopilication with mesh hiatoplasty.

BACKGROUND: Intrathoracic wrap migration is the most frequent morphological anatomic reason for failure of laparoscopic antireflux surgery (LARS). This study investigates whether the size of the esophageal hiatus is a factor in reherniation after LARS with mesh hiatoplasty and after primary failed hiatal closure. METHODS: Fifty-four patients who underwent a laparoscopic 270° Toupet fundoplication with simple sutured crura and posterior onlay of Parietex mesh prosthesis between October 2003 and June 2008 were evaluated with respect to the occurrence of postoperative intrathoracic wrap migration/reherniation. Indication for mesh hiatoplasty was a hiatus with a hiatal surface area (HSA) of at least 5.60 cm(2) or slippage after the first LARS. The integrity of repair was assessed using a barium swallow test. Cinematography was performed at a median of 25.6 months (3-63 months after operation) and was completed in 49 of 54 patients (90%). Follow-up was completed in 24 patients who underwent primary LARS (group A) and 25 patients who underwent a laparoscopic refundoplication (group B). RESULTS: In group A, the occurrence of postoperative wrap reherniation was diagnosed in 20.8% of the patients, compared to 40% in group B. In both groups only one patient with recurrent hiatal hernia was symptomatic. In group A, patients who developed a recurrent hernia had a larger HSA than patients without postoperative reherniation. There was a huge difference in the size of the HSA between symptomatic and asymptomatic patients with reherniation. In comparison, group B patients had HSA of similar size in all described cases. CONCLUSION: In primary intervention, recurrence of hiatal hernia is more likely the larger the HSA is. The size of the hiatus is a major contributing factor to the possibility of reherniation. After failed primary hiatal closure, the size of the hiatal defect is no marker for the possibility of reherniation.

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.

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.