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Surg Endosc (2011) 25:1004–1011 DOI 10.1007/s00464-010-1369-3

A review of 130 humans enrolled in transgastric NOTES protocols at a single institution Peter Nau • E. Christopher Ellison • Peter Muscarella Jr. • Dean Mikami • Vimal K. Narula • Bradley Needleman • W. Scott Melvin • Jeffrey W. Hazey

Received: 5 April 2010 / Accepted: 3 September 2010 / Published online: 26 October 2010 Ó Springer Science+Business Media, LLC 2010

Abstract Background The methodology of Natural Orifice Translumenal Endoscopic Surgery (NOTES) has been validated in both human and animal models. Herein is a discussion of our experience gained from the initial 130 patients enrolled in transgastric pre-NOTES and NOTES protocols at our institution. Methods A retrospective review of our research database was performed for all patients enrolled in NOTES protocols. The infectious risk of a gastrotomy with and without a NOTES procedure was assessed in 100 patients. Eighty patients completed a true NOTES protocol looking at staging, access, and insufflation with select patients evaluating the potential for bacterial contamination of the abdominal compartment. Results A total of 130 patients have completed preNOTES and NOTES protocols at our institution. We

P. Nau P. Muscarella Jr. V. K. Narula J. W. Hazey Division of General Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Columbus, OH 43210-1228, USA D. Mikami B. Needleman W. S. Melvin Center for Minimally Invasive Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Columbus, OH 43210-1228, USA E. C. Ellison Department of Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Columbus, OH 43210-1228, USA J. W. Hazey (&) Department of Surgery, The Ohio State University Medical Center, N724 Doan Hall, 410 West 10th Avenue, Columbus, OH 43210-1228, USA e-mail: [email protected]

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observed no clinically significant contamination of the abdomen secondary to transgastric procedures in 100 patients. Diagnostic transgastric endoscopic peritoneoscopy (DTEP) was completed in 20 patients with pancreatic head masses and found to have a 95% concordance with laparoscopic exploration for assessment of peritoneal metastases. Blind endoscopic gastrotomy and DTEP were evaluated in 40 patients who underwent laparoscopic Roux-en-Y gastric bypass procedures (LSRYGB) and were found to be safe, reliable, and without a clinically significant risk of contamination. Endoscopic peritoneal insufflation was successfully established and correlated with standard laparoscopic insufflation in 20 patients. Conclusions Transgastric NOTES is a safe alternative approach to accessing the peritoneal cavity in humans. The risk of bacterial contamination secondary to peroral and transgastric access is clinically insignificant. A device for the facile closure of the gastric defect is the sole factor limiting institution of this methodology as a standalone technique. Keywords Transgastric surgery Endolumenal surgery Natural orifice translumenal endoscopic surgery

In 2004, Kalloo introduced the concept of natural orifice surgery in a discussion of a series of transgastric peritoneoscopies performed in a pig model [1]. In response to this work and unpublished international techniques, the ASGE/ SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery released the White Paper in which they outlined the challenges that must be overcome for the expansion of this model into a human population [2]. Some of the issues identified include the physiologic implications of the procedure, safe access to the peritoneal cavity,

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assessment of the infectious risks, and technical development of suturing and anastomotic devices. Since that time, investigators have addressed many of the aforementioned questions in animals and humans. Natural orifice surgery encompasses several different approaches to the abdomen. Previously described methodology for accessing the peritoneal cavity includes transvaginal, transgastric, and transcolonic techniques. Currently, there is no consensus on the most appropriate approach. The colpotomy and transvaginal approach to the abdominal viscera were introduced in 1813 by Konrad Langenbeck with

his description of a transvaginal hysterectomy [3]. The colon also has been extensively studied as a standalone entity in various NOTES models. To date, however, inconsistencies in the infectious implications and friability of the colon have prevented its use in humans and delayed the progress of this approach in animal models [4–6]. Perhaps the most commonly investigated technique for accessing the peritoneal cavity has been via an endoscopically fashioned gastrotomy. Similar to the transvaginal approach, the muscular stomach wall is ideally suited for tolerating the shear forces associated with intra abdominal

Table 1 Summary of transgastric NOTES protocols (organized by investigation) Investigation (n)

Procedure (n)

NOTES access

Results

Bacterial contamination (100)

LSRYGB (50)

None

Gastric to peritoneum cross-contamination in 10% of cases. No infectious complications

Staging of pancreatic head masses (10)

Transgastric with laparoscopic guidance

Gastroscope to peritoneum cross-contamination in 0% of cases. No infectious complications

LSRYGB (40)

Transgastric without laparoscopic guidance




Abdomen access safely and without complication in 100% of cases

LSRYGB (60)


Abdomen access safely and without complication in 100% of cases



95% concordance rate between laparoscopic and endoscopic explorations

LSRYGB (60)


No limitations in visualization based on surgical history or pre-procedure pneumoperitoneum

LSRYGB (20)


Endoscopic insufflation equivalent to laparoscopic insufflation

Transgastric access (80)

Diagnostic accuracy (80)

Peritoneal insufflation and adhesiolysis (20)

Endoscopic adhesiolysis feasible, safe, and reliable

Table 2 Summary of transgastric NOTES protocols (organized by protocol) Protocol (n)

NOTES access

NOTES investigation (n)

Results

LSRYGB (50)

None





Diagnostic accuracy (20)

95% concordance rate between laparoscopic and endoscopic explorations


Gastroscope to peritoneum cross-contamination in 0% of cases. No infectious complications

LSRYGB (40)

LSRYGB (20)



Accessing the peritoneal cavity (40) Abdomen access safely and without complication in 100% of cases Diagnostic accuracy (40)




Accessing the peritoneal cavity (20) Abdomen access safely and without complication in 100% of cases Diagnostic accuracy (20)


Peritoneal Insufflation (20)

Endoscopic insufflation equivalent to laparoscopic insufflation

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maneuvers. Additionally, the low bacterial load within the acidic milieu of the stomach decreases the infectious risk to which the patient is exposed. With that said, the preponderance of data for the therapeutic application of NOTES currently available in humans incorporates the transvaginal approach. Presently, there are only six publications from North America on transgastric NOTES protocols in a human population [7–12]. Natural orifice surgery may represent the next permutation in minimally invasive techniques, marking a shift from the laparoscopic or open approach. It is this sentiment that has driven the extensive research that has been conducted in the field since its inception 5 years ago. At our institution, we have focused on the potential of transgastric endoscopic peritoneoscopy (TEP). Issues that we have studied include bacterial contamination, transgastric peritoneal access, diagnostic utility of transgastric endoscopic peritoneoscopy, endoscopic peritoneal insufflation, and endoscopic peritoneal adhesiolysis. Approval by the Institutional Review Board was granted for all clinical studies before initiation. HIPPA compliance was maintained throughout the data collection process. Tables 1 and 2 illustrate the breakdown of the cases completed based on protocol and investigation.

Methods Evaluation of bacterial contamination during transgastric procedures Three distinct bacterial contamination experiments were performed for a total of 100 patients. In all cases, a preoperative dose of prophylactic antibiotics was administered. No decontamination of the stomach was performed. Aerobic and anaerobic plate counts were performed by using the spread plate method. All patients were followed for 30 days to assess for late infectious complications. In each case, the scope was cleaned with glutaraldehyde but was not considered sterile. The first study completed evaluated the bacterial contamination of the peritoneal cavity associated with the instrumentation of an open gastrotomy during a LSRYGB in a non-NOTES setting. The second experiment evaluated the intrinsic, pre-procedure contamination of the endoscope. Additionally, the infectious implications of passing the endoscope through the stomach and into the peritoneal cavity were studied. The last cohort of patients assessed the incidence of cross-contamination in a true NOTES procedure as defined by the presence of gastric flora in the postprocedure peritoneal cavity. The methodology for these protocols has been described elsewhere [unpublished data] [8, 13].

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Accessing the peritoneal cavity via a transgastric approach The method used for the establishment of endoscopic access to the peritoneal cavity has been previously described [9]. The initial study evaluated the endoscopic creation of a gastrotomy using laparoscopic guidance. Next, in patients with and without a history of previous surgery, an endoscopic gastrotomy was created without laparoscopic assistance but with preinsufflation of the abdomen. Finally, a gastrotomy was created blindly without preinsufflation of the abdomen in patients with and without a history of previous surgery. In total, 80 patients were enrolled in the aforementioned studies. Diagnostic accuracy and utility The diagnostic accuracy of an endoscopic exploration of the abdomen was evaluated in a total of 80 patients. In all cases, incidental findings and the adequacy of the exploration were scored by a single surgeon on a scale from zero to five. A five was equivalent to no limitations to visualization. In the initial study of 20 patients, the completeness of DTEP for identifying peritoneal metastases in patients with pancreatic head masses was assessed. In an additional 60 patients, the ability to completely surveil the four quadrants of the abdomen endoscopically was studied before completion of a LSRYGB. Endoscopic insufflation and adhesiolysis The ability to insufflate safely the abdomen and perform an endoscopic adhesiolysis was assessed in 20 patients. This procedure has been previously described [10]. In short, after transgastric passage of the endoscope, pneumoperitoneum was established with a standard laparoscopic insufflator attached to the therapeutic channel of the endoscope. A Veress needle was then passed into the abdomen and the pressure recorded for comparison. In those patients with adhesive disease, the needle knife was used to lyse adhesions endoscopically. Data analysis Statistical analyses included unpaired Student’s t test for continuous variables and Chi-square for noncontinuous variables. For non-normal data, the Mann–Whitney and Wilcoxon signed-rank tests were used. Statistical significance was defined as p \ 0.05. All protocols were approved by the institutional review board (IRB) at the Ohio State University Medical Center before institution of the study. HIPPA compliance was maintained throughout the data collection process.

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Results Evaluation of bacterial contamination during transgastric procedures The initial study to evaluate the infectious implications of an open gastrotomy was completed in 50 patients who underwent LSRYGB without an associated NOTES procedure. The mean number of colony-forming units (CFU) in the gastric aspirate was 22,303 CFU/ml. Peritoneal aspirates obtained before gastrotomy creation showed no CFUs in 44 of 50 patients (88%). The mean bacterial counts in the postprocedure peritoneum were 1,102 CFU/ml. In five cases, cross-contamination was documented. Proton pump inhibitor use did not translate to an increase in the peritoneal bacterial load after completion of the anastomosis. Furthermore, no infectious complications developed. The next ten patients evaluated for bacterial contamination were individuals with pancreatic head masses who underwent a DTEP for pancreatic mass staging. Before NOTES, a sterile wash of the endoscope was performed, yielding an average of 132.2 CFU/ml. Aspirates taken from the peritoneal cavity before gastrotomy creation grew on average 160.4 CFU/ml. In the post-gastrotomy aspirate, 642.1 CFU/ml were collected. This value was not significantly different from the pre-procedure peritoneal cavity (p = 0.5). Cross-contamination was not observed. There were no immediate or delayed infectious complications in any subject. The final population evaluated for contamination of the abdomen consisted of 40 patients scheduled for a LSRYGB with concomitant NOTES procedures. The median level of bacterial present in the gastric aspirate was significantly higher than the post-gastrotomy peritoneum (980 vs. 320 CFU/ml; p = 0.001). Patients on PPIs (n = 15) had significantly higher bacterial counts than those not on PPIs (n = 25) (7,800,000 vs. 340 CFU/ml; p = 0.01). However, the use of PPIs did not translate to a higher bacterial load in the peritoneal cavity after transgastric passage of the endoscope (500 vs. 300 CFU/ml, p = 0.1). Cross-contamination was documented in 21% of the cases. There were no infectious complications in this population.

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(p = 0.001). There were two postoperative complications; both were unrelated to the endoscopic exploration. In the next 40 patients, transgastric access and the endoscopic exploration were completed without laparoscopic guidance. There was no difference in the time needed for DTEP for those with and without preinsufflation (19.5 vs. 17.2 min; p = 0.2). There also was no difference in the time to complete DTEP in those with and without a history of intra-abdominal procedures (19.2 vs. 17.8 min; p = 0.6). The time needed to establish transgastric access decreased when comparing the first 20 patients (12.2 min) with the second 20 (9.3 min; p = 0.05). The risk of cautery burn injury during entrance was not increased in those without preinsufflation of the abdomen (p = 0.48) or in those with a surgical history (p = 1.00). The final population had transgastric access established and DTEP completed without laparoscopic guidance or preinsufflation. The average time for completion of DTEP was 16.1 (range, 9–23) minutes. The mean time did not vary based on the presence or absence of previous abdominal surgeries (p = 0.3). There were nine small cautery burns noted after the procedure. The risk was not influenced by the presence or absence of previous abdominal surgeries (p = 0.2). Diagnostic accuracy In the first study, the results of the DTEP agreed with laparoscopic findings for surgical decision making in 19 of 20 patients (95%). A single malignant lesion was missed on DTEP. This lesion was sampled during the initial laparoscopic exploration and was no longer present. In total, 60 patients underwent LSRYGB with pre-procedure DTEP. Using the aforementioned grading scale, the mean score was 4.8 of 5. There was no difference in the ability to visualize any quadrant of the abdomen when cataloging patients based on the presence or absence of previous abdominal operations (4.82 vs. 4.77; p = 0.6). There also was no difference in the ability to adequately explore the four quadrants in those cases with preinsufflation of the abdomen and in those without (4.75 vs. 4.83; p = 0.4). Endoscopic insufflation and adhesiolysis

Accessing the peritoneal cavity via a transgastric approach Twenty patients with pancreatic head masses underwent DTEP under laparoscopic guidance. The mean time for completing DTEP was 21 (range, 10–34) minutes. Experience gained during the first ten cases translated to a 7-min decrease in the second ten patients (p = 0.016). The majority of this decrease was accounted for by the 6-min reduction in time needed to access the peritoneal cavity

Twenty patients were enrolled in the study to evaluate the accuracy and safety of insufflating the peritoneal cavity through the endoscope. There was no difference in the endoscopic and laparoscopic pressure readings (9.8 vs. 9.8; p = 0.9). The pressure readings from patients with and without a previous surgical history were not significantly different (9.67 vs. 9.17; p = 0.5). Furthermore, previous abdominal surgery did not decrease the accuracy of endoscopic insufflation (10.6 vs. 9.0; p = 0.3).

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Endoscopic adhesiolysis was performed on one patient. There were no adhesion locations that were not amenable to lysis from an endoscopic approach in this patient. There were no complications secondary to this technique. Tables 1 and 2 illustrate the breakdown of the cases completed based on protocol and investigation. Table 1 presents the data organized according to the question being addressed (i.e., infectious risks, access, insufflation, etc.). Table 2 is a graphical illustration of the studies broken down by protocol.

Discussion Similar to the introduction of laparoscopy, which was initially criticized as unrealistic and dangerous, NOTES has been acknowledged as an important technique warranting further investigation. Many have approached this topic through the description of novel operations incorporating a natural orifice for its completion. Reports of entirely endoscopic appendectomies and laparoscopicassisted cholecystectomies have been published from both the transvaginal and transgastric routes [14–21]. This commentary is vital to the expansion of NOTES in that it provides a foundation for the continued technical innovation necessary for the progression of the field. Our experience with natural orifice methodology has focused on identifying limitations to the progression of NOTES and designing protocols to address these issues. Infectious implications The initial question that we addressed was the identification of potential infectious risks to which the patient is exposed during a translumenal procedure and specifically a transgastric approach. Many investigators have approached this topic in animal models. The validity of translating this data to a human population is questionable. Most trials have ‘‘sterilized’’ the gastric lumen with Betadine or antibiotic-enriched washes before accessing the abdomen [1, 22–24]. Few have attempted to address the infectious potential of a transgastric procedure in a human population. We first designed a study to establish the baseline risk of an open gastrotomy without NOTES [13]. The mean number of colony-forming units (CFU/ml) in the peritoneal cavity after gastrotomy was significantly lower than in the stomach (p \ 0.05). The bacterial load also was higher in the contaminated peritoneum than in the peritoneum before gastrotomy (p \ 0.01). With that said, the peritoneal cavity remained sterile in greater than half of the participants following gastrotomy creation. It should be noted that patients taking PPIs had a significantly higher bacterial load in their gastric aspirates (p \ 0.02). There was,

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however, no correlation between the bacterial load in the stomach and peritoneal load after gastrotomy in the face of PPI use. Furthermore, there were no abscesses, infections, or anastomotic complications in any patients who manifested evidence of cross-contamination from gastric contagion. There is contamination of the abdomen from an open gastrotomy; however, the bacterial load is low, is not clinically significant, and does not require pre-procedure decontamination. This is not a surprise as we do the same with open surgery. Having established a baseline risk of infection, we evaluated the infectious potential of the transgastric passage of an endoscope [25]. Our first step was to verify that the endoscope was not a source of contamination. We noted that the number of CFU/ml were virtually identical for the scope wash and pre-gastrotomy presumably sterile peritoneal sample (p = 0.6). To evaluate the contamination associated with a NOTES procedure, we compared washes of the peritoneum before and after DTEP. We found no significant difference between the bacteria isolated from either sample (p = 0.1). In this way we were able to suggest that the intrinsic cleanliness of the scope does not pose an infectious risk. Furthermore, the act of passing the scope through the oropharynx and stomach out into the peritoneal cavity does not expose the patient to a clinically significant increased risk of infection. The last question we sought to answer was what the potential was for cross-contamination of the peritoneal cavity with gastric flora during a transgastric procedure [unpublished data]. The level of bacteria in the peritoneum after DTEP was markedly lower than the amount in gastric aspirates (p \ 0.001). A subgroup analysis of those individuals taking PPIs showed that the bacterial load was significantly higher in the gastric aspirates (p = 0.008). This did not, however, translate to higher bacterial counts in the peritoneal cavity after DTEP. In 23% of the cases, there were identical species in the stomach and peritoneal aspirates, which indicated that cross-contamination had occurred. There were no infectious complications in this cohort of 40 patients. It is clear there is a potential for cross-contamination of the abdominal cavity. However, the endoscope does not inherently pose an infectious risk to the patient. Furthermore, there is no correlation between the bacterial load within the stomach and the extent of peritoneal contamination. This held true independent of the use of PPIs or an increased bacterial load within the stomach. In no case were there any negative outcomes secondary to NOTES, including wound infections, abscess formation, or anastomotic failures. It should be noted that all gastrotomies were addressed in an acceptable surgical fashion (stapled closure or excision). In our evaluation of 100 patients, no evidence would discourage additional investigation of a transgastric

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NOTES procedure due to unacceptably high infectious complications. Peritoneal cavity access There exists a great deal of variability in the approaches proposed to access the peritoneal cavity. Some have advocated for the colonic approach due to the fact that its location provides an excellent vantage point from which to explore the abdomen. Investigators have described transcolonic colon resections with primary anastomoses, pancreatectomies, and ventral hernia repairs in animal models [4–6, 26, 27]. To date, however, inconsistencies in the infectious outcomes have complicated the progress of this approach in animal models. One group noted microabscesses at the colonic access site in all animals [5]. Conversely, another investigator documented no infectious complications associated with the transcolonic placement of synthetic mesh for a ventral hernia repair [6]. Other investigators have promoted a transvaginal approach, with supporting literature showing that the colpotomy can be reliably closed while at the same time providing unhindered access to the majority of the abdomen. Descriptions of transvaginal procedures for different pathology have been published, including ventral hernia repairs and solid organ removal in both animal and human populations [12, 14–21, 28, 29]. The transvaginal methodology does have limitations. It is only applicable to half of the population. Furthermore, there is evidence of resistance to this approach from both professional and nonmedical groups [30]. We have concentrated our efforts on the development of a transgastric technique. Blind access to the stomach was first described almost 30 years ago with Gauderer’s account of the percutaneous endoscopic gastrostomy (PEG) tube [31]. To date, this approach has been reported in many different operations, including hernia repairs, bowel anastomoses, and solid organ removal [11, 22, 26, 32–36]. Additionally, the muscular stomach wall will easily tolerate the shearing forces associated with intra-abdominal endoscopic manipulation. There have been several proposed methods for accessing the abdominal cavity via the stomach and even more for closure of the defect; very few have been validated in a human model. The potential for complications secondary to the closure of a gastrotomy was a major concern in the design of our human protocols. This risk was circumvented in our studies with the enrollment of patients whose primary operation required a gastrotomy. The initial protocol enrolled 20 patients with a pancreatic head mass concerning for malignancy [7, 8]. Gastrotomy creation and endoscopic exploration were performed under laparoscopic guidance. In all 20 patients, the anterior wall of the stomach was safely crossed and then dilated to

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create a gastrotomy through which the scope was passed. Additionally, gastrotomy placement was consistent and accurate in its positioning. This protocol was important in that it established the safety of the creation of an endoscopic gastrotomy with the aid of laparoscopic visualization to ensure patient safety. Next, we addressed the viability of this technique as a standalone approach to accessing the abdomen [9, 10]. In a total of 60 patients, endoscopic transgastric access was successfully established without laparoscopic guidance. The position of the gastrotomy was consistent and precise in its location. Additionally, the peritoneum was successfully accessed in all 60 patients. There were no major complications related to this protocol. In 17 patients, small, 2–3-mm cautery burns to the anterior abdominal wall or left lateral segment of the liver were made in the process of creating the gastric defect. The risk of sustaining a burn injury was not increased in those without preinsufflation of the abdomen (p = 0.5) or with a surgical history (p = 0.8). All patients experienced an uneventful recovery. Diagnostic accuracy Intrinsic to the validation of NOTES as an alternative surgical approach to intra-abdominal pathology is the necessity of a diagnostic accuracy comparable to that offered by a laparoscopic approach. The ability to completely explore the abdomen has been confirmed in many animal investigations [1, 35]. To date, however, there are few reports of a translumenal diagnostic exploration in a human model. We addressed this deficiency in two studies. In the initial series of 20 patients, we evaluated the ability of an endoscopic exploration to identify distant metastases in patients with suspected pancreatic cancer [7, 8]. There was clinical agreement between the laparoscopic and endoscopic findings in 95% of the cases when used for peritoneal staging. The single disagreement between the two approaches was a malignant focus that was completely removed during the laparoscopic biopsy. The next protocols evaluated TEP in 60 patients scheduled for a LSRYGB procedure [9, 10]. There were no quadrants of the abdomen or previous operations that were unable to be visualized endoscopically. There were three patients who were not completely explored. In two subjects, there was extensive omental fat that complicated exploration. This is not unexpected given that the population being studied had a primary diagnosis of morbid obesity. Another patient with a complicated surgical history had adhesions that limited visualization despite a prolonged laparoscopic adhesiolysis. In two cases there was limited visualization despite having pre-procedure pneumoperitoneum. This supports the conclusion that there are no circumstances that precluded the patient’s

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enrollment into a NOTES protocol, but like any other open or laparoscopic procedure, visualization may be compromised as a function of the technique used for access. We appreciate the fact that transgastric therapeutic interventions (i.e., NOTES cholecystectomies) may pose additional hurdles for successful completion that are not inherent to a diagnostic procedure. Visualization and operating in the right upper quadrant are clearly two different issues. Endoscopic insufflation and adhesiolysis The next barrier that we addressed was the ability to insufflate the abdomen endoscopically [10]. No difference was found in the mean endoscopic and laparoscopic pressures (9.8 and 9.8 mmHg; p = 0.9). Additionally, despite a significant difference in the presence of adhesions in those individuals with and without a surgical history (80 vs. 10%; p = 0.005), there was no difference in the ability to adequately visualize all four quadrants of the abdomen. There are little data to suggest that endoscopic CO2 insufflation via the biopsy channel of the endoscope correlates with laparoscopic insufflation pressures. We studied this in 20 patients by first gaining access and then insufflating the peritoneum via the endoscope using the laparoscopic insufflator set to 10 mmHg. A therapeutic pressure of 15 mmHg was avoided because of concerns for intra-abdominal hypertension should the endoscopic and laparoscopic pressures not correlate. Patients with a history of multiple abdominal interventions may require alternative methods for accessing the peritoneal cavity. Adhesive disease may render blind Veress needle or a cut down technique prohibitively dangerous. A transgastric approach to the abdominal cavity establishes an alternative route to the abdominal cavity and an additional technique to safely insufflate the peritoneum. Pneumoperitoneum can be achieved with a comparable efficacy and safety to laparoscopic techniques irrespective of the patient’s past surgical history.

Conclusions The infectious potential is clinically insignificant and is not dependent on decontamination of the gastric lumen. The transgastric approach to natural orifice surgery is a legitimate alternative technique for accessing the peritoneal cavity. Furthermore, the safety profile for gaining access is not dependent on laparoscopic guidance or the presence of preinsufflation of the abdomen. It is a technique that can be safely and accurately applied without considerations for the patient’s surgical history. In the event that adhesive disease is encountered, an endoscopic adhesiolysis can be completed safely and precisely. The significance of an endoscopically created pneumoperitoneum is no different than

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that of a laparoscopically created pneumoperitoneum. The sole limiting factor to the institution of this methodology as a standalone technique is a safe and reliable means to close a gastrotomy endoscopically. Disclosures E. Christopher Ellison, Peter Muscarella, Jr., Dean Mikami, Vimal K. Narula, Bradley Needleman, W. Scott Melvin, Jeffrey W. Hazey. Peter Nau, MD, received a Covidien Training Grant. W. Scott Melvin, MD, serves on the Advisory Board for Endogastric Solutions, Surgiquest and Stryker. He also received Training Grants from Covidien and Stryker. Dean Mikami, MD, is a consultant for Covidien, Gore and Endogastric solutions. Bradley Needleman, MD, received a Covidien Research Grant. Jeffrey W. Hazey, MD, received a Stryker Research Grant, a Boston Scientific Training Grant, and is on the Clinical Advisory Board for Covidien and Ethicon. Peter Muscarella, Jr., MD, Vimal K. Narula, MD, Benjamin Yuh, Joel Anderson, MD, E. Christopher Ellison, MD, Lynn Happel, MD, and Ron Memark, MD, have no conflicts of interest or financial ties to disclose.

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