David Earle

Development of a rapid response plan for intraoperative emergencies: the Circulate, Scrub, and Technical Assistance Team.

BACKGROUND Unplanned intraoperative events are inevitable and cause stress and inefficiency among staff. We believe that developing a technical rapid response team with explicitly defined, narrow roles would reduce the amount of chaos during such emergencies. This article provides a detailed description of the development and implementation of such a program. METHODS In-situ simulation of an intraoperative emergency was used for a formal assessment of the current practice. Debriefing sessions identified areas of improvement and solicited solutions. A multidisciplinary working group then developed and implemented the technical rapid response team based on the needs assessment. The program was designed to create a Circulating, Scrubbing, and Technical Assistance Team that helps with equipment, supplies, anesthesia, and communication. RESULTS We anticipate the program will foster a culture of safety, and promote positive relationships and attitudes of the entire multidisciplinary team. CONCLUSIONS In the future, research regarding patient outcomes and staff satisfaction and safety attitudes may help provide objective evidence of the benefits of the program.

The NOVEL trial: natural orifice versus laparoscopic cholecystectomy—a prospective, randomized evaluation

Introduction The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR® collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES® cholecystectomy as an alternative procedure to laparoscopic cholecystectomy.MethodsNinety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performed in total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES® group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes.ResultsThere were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES® group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (p = 0.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (p < 0.05).ConclusionThe safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification.

The History of NOTES

Natural orifice translumenal endoscopic surgery (NOTES™) was officially born in 2005 when a forward thinking group of gastroenterologists and surgeons convened to discuss, organize, codify, and elucidate concerns about this potential new disruptive surgical idea. This meeting came on the heels of a report of “flexible transgastric peritoneoscopy” from Johns Hopkins University [1] and several subsequent experiments in animal models expanding upon the possibilities this technique represented [2]. The NOTES moniker was adopted at this meeting, as was the formation of the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR®) [2]. But a peek into the history of surgery via the natural orifice reveals that the idea was an old one, dating back into the 1800s in some cases. Many animal experiments were performed, demonstrating many new and novel techniques to commonly performed operations, and scientific investigation was undertaken to determine the safety and feasibility of these approaches. Human work began to emerge in 2005 and continues to develop; in some cases, becoming widely adopted.

NOTES Hernia Repair

Hernias are one of the most commonly treated general surgical problems, with over 20 million procedures per year. Despite the frequency of occurrence, modern techniques remain troubled by long-term recurrence and chronic pain syndromes postoperatively. Innovative techniques such as employing a natural orifice approach to the abdomen have the potential to reduce some of the concerns about current hernia operations. While there are scattered case reports about human NOTES hernia repairs, there has been an abundance of animal work demonstrating safety and feasibility. Work remains before widespread adoption of such a technique could take place.