Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expanding metal stents in benign upper gastrointestinal conditions: a comparative multicenter international study (with video).

BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper gastrointestinal (GI) conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Ovesco Endoscopy) for stent anchoring has been recently developed. The aim of this study was to evaluate the effect of OTSC fixation on SEMS migration rate. METHODS: A retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions between 1/2011 and 10/2022 at 16 centers. The primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events. RESULTS: A total of 311 (no fixation 122, OTSC 94, endoscopic suturing 95) patients underwent 316 stenting procedures. Compared to the no fixation (NF) group (n=49, 39%), the rate of stent migration was significantly lower in the OTSC (SF) (n=16, 17%, p=0.001) and endoscopic suturing (ES) group (n=23, 24%, p=0.01). The rate of stent migration was not different between the SF and ES groups (p=0.2). On multivariate analysis, SF (OR 0.34, CI 0.17-0.70, p<0.01) and ES (OR 0.46, CI 0.23-0.91, p=0.02) were independently associated with decreased risk of stent migration. Compared to the NF group (n=64, 52%), there was a higher rate of clinical success in the SF (n=64, 68%; p=0.03) and ES group (n=66, 69%; p = 0.02). There was no significant difference in the rate of adverse events between the three groups. CONCLUSION: Stent fixation using OTSC is safe and effective at preventing stent migration and may also result in improved clinical response.

Retrospective Analysis of Rectal Endoscopic Submucosal Dissection at Ordensklinikum Linz and Kepler Universitätsklinikum Linz.

Background and study aim: Endoscopic submucosal dissection is a minimally invasive endoscopic procedure for the removal of neoplastic benign and early malignant lesions in the gastrointestinal tract. In this study, we analyse the success and safety of rectal ESD at Linz hospitals, focusing on a specific endoscopist. Additionally, we examine whether there is a learning curve regarding success parameters. Methods: This retrospective study included all 102 patients who underwent endoscopic submucosal dissection of the rectum by a defined endoscopist at Ordensklinikum Hospital and Kepler University Hospital between December 2010 and May 2021. With the collected data, a descriptive statistic was carried out and regression analyses were performed. Results: The en bloc resection rate was 78.4% and the rate of lesions removed in healthy tissue was 55.6%. The average procedure time was 179 min and the complication rate was 7.8%. In total, 26.4% of cases showed carcinoma; in 25.9% of these cases, an oncologically curative resection was achieved with ESD. Follow-up data were available for 61.1% of cases, with recurrence being diagnosed in 3.6% of cases. A learning curve was observed regarding the rate of lesions removed in healthy tissue and the procedure time, but not regarding the en bloc resection rate. Conclusions: Endoscopic submucosal dissection is a safe method for the removal of large rectal adenomas and early carcinomas. The en bloc resection rate of the analysed procedures is within the range of comparable European studies. The rate of lesions removed in healthy tissue is below the R0 resection rate of the comparative literature; however, a learning curve could be observed in this parameter.

Endoscopic Submucosal Dissection in the Upper Gastrointestinal Tract and the Need for Rescue Surgery-A Multicenter Analysis.

Endoscopic submucosal dissection (ESD) has become the standard treatment for early malignant lesions in the upper gastrointestinal (GI) tract. Its clinical results have been reported to be as good as surgery. The outcomes of rescue surgery after non-curative ESD have been reported to be as good as first-line surgery. The aim of this study was to evaluate the outcomes of ESD in the upper GI tract and the outcomes of rescue surgery after non-curative ESD performed in Linz, Austria, between 2009 and January 2023. A total of 193 ESDs were included and divided into 104 esophageal ESD and 89 gastric ESD procedures. The criteria for curative ESD were in line with established guidelines' recommendations. For esophageal lesions, the mean lesion size was 40.3 mm and the rate of curative ESD was 56.7%. In the non-curative ESD, the rate of technical failure as the reason for non-curative ESD was 13.3% and the oncological failure rate was 86.7%. Only 48.7% of indicated rescue surgeries were performed. The main reason for not performing surgery was interdisciplinary consensus due to comorbidity. Perioperative complications Dindo-Clavien ≥ 3 occurred in 22.2% of cases with an in-hospital mortality rate of 0. In gastric lesions, the mean size was 39 mm and the rate of curative ESD was 69.7%. The rate of technical failure as a reason for non-curative ESD was 25.9% and the oncological failure rate was 74.1% for non-curative ESD. Rescue surgery was performed in 48.2% of indicated cases. The perioperative rate for major complications was 0. The outcome of ESD in the upper GI tract is in line with the published literature, and non-curative ESD does not worsen surgical outcomes. The available follow-up data are in line with the international published literature, showing a low rate of residual malignancy in surgical resection specimens. Therefore, the indication of rescue surgery for oncological failure remains challenging. Furthermore, the learning curve of ESD has shown a trend towards improving outcomes over time.

Endoscopic Transmural Therapy of Pancreatic Fistulas in an Interdisciplinary Setting-A Retrospective Data Analysis.

Pancreatic fistulas belong to the most feared complications after surgery on or near the pancreas, abdominal trauma, or severe pancreatitis. The majority occur in the setting of operative interventions and are called postoperative pancreatic fistulas (POPF). They can lead to various complications, including abscesses, delayed gastric emptying or hemorrhages with a significant impact on morbidity and mortality. Several risk factors have been identified, including smoking, high BMI, male gender, and age. Prophylactic measures and treatment options have been explored but with limited success. This study aimed to analyze the incidence and management of pancreatic fistulas treated in a tertiary referral center, particularly focusing on an endoscopic approach. The data of 60 patients with clinically relevant pancreatic fistulas were analyzed between 2018 and 2021. Different treatment approaches, including conservative management, percutaneous drainage, transpapillary stenting, and endoscopic transmural drainage, were evaluated. An endoscopic transmural approach using lumen-apposing metal stents (LAMS) was used in almost half of this cohort showing promising results, with a high rate of fistula closure in refractory cases and a mean time until closure of 2.7 months. The findings suggest that an endoscopic approach, particularly using LAMS, can be effective in the management of pancreatic fistulas.

Biodegradable biliopancreatic stents could help conserve health care resources during the COVID-19 pandemic: An observational multicenter study.

BACKGROUND: Considering limited resources for follow-up due to COVID-19, we used biodegradable stents (BPBS) for a range of biliopancreatic diseases. AIMS: This observational multicenter study aimed to evaluate technical safety and give first insights into clinical utility. METHODS: Technical success, clinical success, and necessity of follow-up visits for BPBS placed at three Austrian tertiary care hospitals between April 2020 and January 2021 were retrospectively analyzed. RESULTS: 63 stents were deployed in 60 patients. Main indications were prophylaxis of post-ERCP pancreatitis (PEP; n = 30/63; 48%) and bridging of prolonged waiting times to cholecystectomy (n = 21/63; 33%). Median time to surgery was 47 days (range: 136 days). The technical success rate was 94% (n = 59/63; 95% CI [0.84, 0.98]). Technical difficulties primarily arose with dislocations. Clinical success was achieved in 90% (n = 57/63; 95% CI [0.80, 0.96]). Clinical failure despite successful deployment was caused by papillary bleeding (1 patient) and cholestasis (1 patient). Both required reinterventions. No follow-up visits were needed in 97% of cases (n = 57/59; 95% CI [0.88, 1.00]). CONCLUSION: Biodegradable stents could help conserve health care resources without compromising treatment standards for PEP prophylaxis, which is particularly valuable in times of restricted resources. First insights into feasibility as bridging to cholecystectomy indicate a favorable safety profile.

Flexible diverticulotomy for Zenker's diverticulum - a bicentric study.

INTRODUCTION: Flexible diverticulotomy is an established procedure for the treatment of Zenker's diverticulum. In a bicentric study, we investigated the development of the procedure since its introduction at the Ordensklinikum Linz Barmherzige Schwestern and Elisabethinen in 2010. METHODS: All flexible diverticulotomies performed between January 2010 and December 2019 at the above-mentioned clinics were evaluated retrospectively. Patients were divided into two 5-year periods (2010-2014 and 2015-2019) and statistical tests were performed for comparison of data. RESULTS: In all, 69 flexible diverticulotomies were performed. The procedure was technically successful in 93.5% of cases. No lethal outcome was encountered. Only 2 (2.9%) interventions led to serious complications which had to be treated in the intensive care unit. Mild complications occurred in 14.5% of cases. 54 patients were evaluated in the follow-up period; 11 (20.3%) patients experienced relapses of dysphagia. The primary intervention resulted in a significant improvement over the observation period. Patients in the second intervention group had shorter average hospital stays and longer recurrence-free intervals. CONCLUSION: Flexible diverticulotomy is a safe and effective procedure for the treatment of Zenker's diverticulum. However, as the success rate appears to depend on the expertise and experience of the department, flexible diverticulotomy should be performed at centers with high caseloads.

Evolution of Transluminal Necrosectomy for Acute Pancreatitis to Stent in Stent Therapy: Step-Up Approach Leads to Low Mortality and Morbidity Rates in 302 Consecutive Cases of Acute Pancreatitis.

Background: The step-up approach, using either flexible endoscopy or a minimal invasive retroperitoneal access, has reduced mortality and morbidity in patients with acute pancreatitis. The use of fully covered self-expanding metal stents (FCSEMS) or lumen apposing metal stents (LAMS) facilitates endoscopic necrosectomy and drainage of walled-off necrosis (WON). The aim of our analysis was to investigate the 30/90/365-day mortality and morbidity rates of the subtypes of the revised Atlanta classification for acute pancreatitis. Materials and Methods: We conducted a retrospective analysis of all patients (n = 302) treated with acute pancreatitis in our institution from January 2014 to July 2017. Mortality, morbidity, management of fluid collections, interventions, complications, and new onset of diabetes were recorded. Results: In 30.8% (n = 93/302) of patients, pancreatic fluid collection developed. Out of these, 58.1% (54/93) required intervention, consisting of endoscopic treatment in 63% (34/54) or multidisciplinary approach in 37% (20/54). Overall, 90-day mortality rate according to Kaplan-Meier Estimator was 3.7%. Overall, 1-year mortality rate was 6.2%. One-year mortality for uncomplicated acute pancreatic fluid collection, pseudocyst, and WON were 5.4%, 2.6%, and 13.5%, respectively. Hemorrhage in case of metal stent treatment (FCSEMS/LAMS) occurred in 14.3%. If LAMS was combined with double pigtail stent-in-stent, bleeding was seen in 5.3%. No transperitoneal necrosectomy was needed. Conclusions: Treating acute pancreatitis with a step-up approach, including stent-in-stent procedures, leads to low mortality rates and few stent-associated bleeding complications and minimizes necessity for open transperitoneal surgical necrosectomy.

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.

Photodynamic therapy with polyhematoporphyrin for malignant biliary obstruction: A nationwide retrospective study of 150 consecutive applications.

BACKGROUND: Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. OBJECTIVE: The objective of this article is to assess the feasibility and safety of this technique. METHODS: In this nationwide, retrospective study of prospectively collected clinical data, all patients treated with PDT using polyhematoporphyrin in Austria from March 2004 to May 2013 were included. Feasibility, adverse events, stent patency and mortality rates were investigated. RESULTS: Eighty-eight patients (54 male, 34 female, median age 69 years) underwent 150 PDT procedures at seven Austrian referral centers for biliary endoscopy. The predominant underlying disease was Klatskin tumor (79/88). All PDT procedures were feasible without technical issues. Cholangitis was the most frequent adverse event (21/88). Stent patency was 246 days (95% CI 203-289) median and was significantly longer for metal than for plastic stents (269 vs. 62 days, p < 0.01). The median survival was 12.4 months (95% CI 9.7-14.9 m) calculated from first PDT and 15.6 months (95% CI 12.3-18.7 m) calculated from initial diagnosis. In patients suffering from biliary tract cancer, Cox regression revealed the number of PDT treatment sessions as the only independent predictor of survival at a multivariate analysis (p = 0.048). CONCLUSION: PDT using polyhematoporphyrin was feasible and safe in this nationwide analysis. Survival data suggest a benefit of PDT in this unselected real-life patient population. Prospective trials comparing PDT to other palliative treatments will help to define its role in the management of malignant biliary obstruction. The study is registered at ClinicalTrials.gov number: NCT02504957.

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.

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.

Endoscopic grading of the gastroesophageal flap valve is correlated with reflux activity and can predict the size of the esophageal hiatus in patients with gastroesophageal reflux disease.

BACKGROUND: Endoscopic grading of the gastroesophageal flap valve (GEFV) is simple, reproducible, and suggested to be a good predictor of reflux activity. This study aimed to investigate the potential correlation between grading of the GEFV and quality of life (QoL), gastroesophageal reflux disease (GERD) symptoms, esophageal manometry, multichannel intraluminal impedance monitoring (MII) data, and size of the hiatal defect. METHODS: The study included 43 patients with documented chronic GERD who underwent upper gastrointestinal endoscopy, esophageal manometry, and ambulatory MII monitoring before laparoscopic fundoplication. The GEFV was graded 1-4 using Hill's classification. QoL was evaluated using the Gastrointestinal Quality-of-Life Index (GIQLI), and gastrointestinal symptoms were documented using a standardized questionnaire. The size of the esophageal hiatus was measured during surgery by calculating the hiatal surface area (HSA). Analysis of the correlation between QoL, GERD symptoms, esophageal manometry, MII data, HSA size, and GEFV grading was performed. Statistical significance was set at a p value of 0.05. RESULTS: A significant positive correlation was found between increased GEFV grade and DeMeester score, total number of acid reflux events, number of reflux events in the supine position, and number of reflux events in the upright position. Additionally, a significant positive correlation was found between HSA size and GEFV grading. No significant influence from intensity of GERD symptoms, QoL, and the GEFV grading was found. The mean LES pressures were reduced with increased GEFV grade, but not significantly. CONCLUSIONS: The GEFV plays a major role in the pathophysiology of GERD. The results underscore the importance of reconstructing a valve in patients with GERD and an altered geometry of the gastroesophageal junction when they receive a laparoscopic or endoscopic intervention.

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.

Optimizing surgical approach for natural orifice translumenal endoscopic procedures.

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) often requires some degree of retroflexion of the endoscopic operating system. This study investigates the impact of retroflexion on task performance in NOTES. METHODS: In a bench-top simulation, surgeons were required to manipulate a single-channel endoscope to touch 4 dots in a predetermined order. The task was performed under the forward-view and retroflexed-view conditions. RESULTS: Tasks performed under the forward-view condition were significantly faster than those performed under the retroflexed-view condition (P = .005). Also, 5 experienced surgeons completed tasks in less time than the novices (P = .043). Experienced surgeons were mildly affected by the inverted image, whereas the novices were vulnerable to image malalignment. CONCLUSION: Careful selection of the surgical approach to avoid image malalignment is suggested for safe performance of NOTES. Extensive training is required for novices to overcome the vision-motion difficulty before they can perform NOTES safely and effectively.

A natural orifice transrectal approach for oncologic resection of the rectosigmoid: an experimental study and comparison with conventional laparoscopy.

BACKGROUND: A transrectal (TR) approach for natural orifice translumenal endoscopic surgery (NOTES) makes sense for colorectal surgery because the colotomy can be incorporated into subsequent anastomosis. Because cancer is a primary indication for left-sided colon resection, oncologic standards will have to be met by a NOTES procedure. This study aimed to assess whether pure TR rectosigmoidectomy can be performed with strict adherence to oncologic principles compared with a conventional laparoscopically assisted approach (LAP). METHODS: Human male cadavers were allocated to either TR (n = 4) or LAP (n = 2). A simulated sigmoid lesion was created at 25 cm. Transrectal retrograde mobilization of the rectosigmoid was performed using conventional transanal endoscopic microsurgery (TEM) instrumentation. After ligation of the superior hemorrhoidal artery and further mobilization, the specimen was delivered transanally and divided extracorporeally. Using a circular stapler, NOTES colorectal anastomosis was performed. Lymph node yield, adequate resection margins, and operative time were compared with LAP. RESULTS: Transrectal retrograde rectosigmoid dissection was achieved in all attempts (4/4) and showed numbers of lymph nodes (median, 5; range, 3-6) similar to the LAP group (median, 4.5; range, 2-7). One pure TR approach failed to resect the lesion. Three TR procedures required additional mobilization via an abdominal approach to provide adequate margins. The mean length of TR specimens was 16 ± 4 cm compared with 31 ± 9 cm achieved by LAP (p < 0.01). The TR operative time was significantly longer (247 ± 15 vs 110 ± 14 min). CONCLUSION: Lymph node yield during TR rectosigmoidectomy was similar to that achieved by the LAP approach. However, conventional TEM instrumentation alone did not permit adequate colon mobilization. This indicates a need for flexible instrumentation or other technical solutions to perform true NOTES colectomies.

Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy.

OBJECTIVE: To compare short-term surgical outcomes and quality of life (QOL) between single-port laparoscopic cholecystectomy (SPLC) and classic 4-port laparoscopic cholecystectomy (CLC). BACKGROUND: There is significant interest in further reducing the trauma associated with surgical procedures. Although a number of observational studies have suggested that SPLC is a feasible alternative to CLC, there is a lack of data from randomized studies validating any benefit over CLC. METHODS: Eligible patients were randomized to receive SPLC or CLC. Operative and perioperative outcomes, including cosmesis and QOL were analyzed. RESULTS: Forty-three patients were randomized to SPLC (n = 21) or CLC (n = 22). There were no significant differences between groups for most preoperative demographics, American Society of Anesthesiology score, gallstone characteristics, local inflammation, blood loss, or length of stay. Patients undergoing SPLC were older than those receiving CLC (57.3 years vs. 45.8 years, P < 0.05). Operative times for SPLC were greater than CLC (88.5 minutes vs. 44.8 minutes, P < 0.05). Overall and cosmetic satisfaction, QOL as determined by the SF-36 survey, postoperative complications, and post-operative pain scores between discharge and 2-week postoperative visit were not significantly different between groups. Wound infection rates were similar in both groups. The SPLC group contained 1 retained bile duct stone, 1-port site hernia, and 1 postoperative port site hemorrhage. CONCLUSIONS: SPLC procedure time was longer and incurred more complications than CLC without significant benefits in patient satisfaction, postoperative pain and QOL. SPLC may be offered in carefully selected patients. Larger randomized trials performed later in the learning curve with SPLC may identify more subtle advantages of one method over another.

Efficacy of using a novel endoscopic lens cleaning device: a prospective randomized controlled trial.

INTRODUCTION: Clear visualization of the surgical field is critical in laparoscopic surgery. The authors evaluated a device that does not necessitate an external cleaning process for the laparoscope. It was hypothesized that it will minimize the interruption in operative workflow. METHODS: A total of 40 advanced laparoscopy patients were randomized to either the control or device group. Demographic data, procedural data, length of stay, frequency and duration of lens cleaning, and lens clarity scores (LCS) were recorded. Independent samples t test and Fisher's exact test were performed. RESULTS: No significant difference was found between the device and control groups in demographic data, procedure time (P = .922) or LCS (P = .124). Laparoscope cleaning in the device group was significantly shorter than in the control group (P < .001). No complications were observed. CONCLUSION: An intra-abdominal laparoscopic cleaning device can effectively clean the laparoscopic lens and lead to less workflow interruption. Although not documented in this study, it may also lead to shorter operative times.