[Structured Implementation and Modular In-house Training as Key Success Factors in Robotically Assisted Surgery - Evaluation Using the Example of Colorectal Surgery]. / Strukturierte Implementierung und modulares inhouse Training als zentrale Erfolgsfaktoren in der robotisch assistierten Chirurgie ­ Evaluation am Beispiel der kolorektalen Chirurgie.

OBJECTIVES: To demonstrate the applicability of structured implementation of robotic assisted surgery (RAS) and to evaluate a modular training procedure during the implementation phase in in-house mentoring. METHOD: Execution of a self-defined PDCA (PDCA: Plan-Do-Check-Act) implementation cycle accompanied by prospective data collection of patient characteristics, operation times, complications, conversion rates and postoperative length of stay of a modularly defined training operation (robotic assisted rectosigmoid resection - RARSR). RESULTS: Evaluation of 100 consecutive cases distributed among 3 trainees and an in-house mentor as internal control group. Presentation of qualitatively safe and successful implementation with a short learning curve of the training operation with balanced patient characteristics. CONCLUSIONS: Structured implementation enables the safe introduction of RAS in visceral surgery. In this context, modular training operations can facilitate the adoption of RAS by users under everyday conditions. For the first time, we demonstrate this within an in-house mentoring approach.

Less pain after transvaginal cholecystectomy: single-center pooled analysis.

BACKGROUND: We previously reported outcome after transvaginal cholecystectomy (TVC) from two cohort studies and a randomized controlled trial. We now present a pooled analysis of postoperative pain scores. DESIGN: Single-center data of postoperative pain after TVC from a level II hospital between October 2007 and June 2012. METHODS: Female patients, above 18 years with symptomatic cholecystolithiasis, received either TVC or conventional laparoscopic cholecystectomy (CLC). Follow up 4 days. The primary outcome of the study was pain after surgery. Pain was measured via a visual rating scale. Descriptive statistics include age, body mass index (BMI), ASA grade, surgical times, number of trocars, complications and hospital stay as well as pain medication. Pain data were assessed against histologic findings. RESULTS: The combined register included 316 patients. Of these, 7 patients were excluded from analysis due to conversion to open surgery, complications and denial of follow-up. There were 141 patients in the TVC and 168 in the CLC group. There was no difference in age, ASA grade, surgical times, complications or hospital stay. BMI was significantly different with an average BMI of 27.1 in the TVC and 28.7 in the CLC group (p = 0.027). The numbers of trocars were significantly different as expected. There was no difference in postoperative pain medication. Pain scores were significantly different on day two to four. Multivariate testing revealed no dependence between postoperative pain and histologic findings. CONCLUSION: On smaller patient numbers, we were previously unable to demonstrate a consistently, significant difference for postoperative pain in our cohort and randomized studies. The pooled analysis suggests that there is an advantage with less postoperative pain after transvaginal compared to standard laparoscopic cholecystectomy.

Postoperative pain after transvaginal cholecystectomy: single-center, double-blind, randomized controlled trial.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has the potential to reduce postoperative pain. We compared postoperative pain in the hybrid NOTES procedure transvaginal video-assisted cholecystectomy (TVC) with standard conventional laparoscopic cholecystectomy (CLC). DESIGN: Single-center, double-blind, randomized controlled trial in a level II hospital between June 2008 and June 2012. METHODS: Female patients, older than 18 years of age with symptomatic cholecystolithiasis were randomized to receive either TVC or CLC. The follow-up period was 7 days and the primary outcome of the study was postoperative pain. We hypothesized that there is no reduction of pain (Visual Rating Scale ≥1) while resting or coughing over a 48-h period after the operation. Secondary outcome included wound infections, complications, and patient reported outcomes. Sealed envelopes with computer-generated randomization information were kept for allocation in theater. All patients received opaque wound dressing, as in standard four-trocar cholecystectomy and a vaginal tamponade. Theater protocol and surgical notes were kept separate after the procedure. RESULTS: Overall, 97 of 426 patients assessed for participation were randomized for either TVC or CLC. A total of 41 patients had a TVC and 51 had a CLC. Five patients were excluded from the analysis. There was no difference in age, body mass index, American Society of Anesthesiologists (ASA) grade, or hospital stay, but anesthetic and surgical times were significantly longer in TVC (p < 0.001). There was no statistical difference in postoperative pain between the two groups while resting or coughing. Complications included conversion to laparotomy, bleeding, wound infections, and re-admission. No difference in the rate of complications between the two groups was seen. Overall, 86 and 93% of CLC and TVC patients, respectively, would recommend the procedure to other patients. CONCLUSION: In this study, no significant difference in pain on days 1 and 2 postoperatively between the two methods was found. The safety profile of TVC is comparable to CLC, and TVC patients would generally recommend this procedure to other patients.

Prospective evaluation of transvaginal assisted cholecystectomy.

BACKGROUND: Transvaginal video-assisted cholecystectomy (TVC) has so far not been prospectively evaluated using an internationally recognized health-related quality of life (HRQoL) assessment. We report the results of a prospectively studied cohort of patients with clinical and quality of life data. METHODS: Prospectively controlled study of 128 patients undergoing TVC and 147 patients with conventional laparoscopic cholecystectomy (CLC). Data reported include patient demography, body mass index, anesthetic risk score (ASA), laboratory data, surgical times, length of hospital stay, pain score, analgesic medication used, complications, and quality of life scores using the combined method of SF-36 and GIQoL. RESULTS: Ninety-five TVC and 96 CLC patients fully completed pre- and postoperative HRQoL questionnaires. Patients with incomplete or missing questionnaires were excluded as well as patients with signs of acute cholecystitis. Differences included cardiovascular comorbidity and previous surgical procedures, but there was no difference in age (p = 0.4), body mass index (p = 0.4), ASA grade (p = 0.4), or preoperative quality of life. No difference was seen in laboratory data, surgical times, or length of hospital stay. Pain score and analgesic medication showed a clear trend and significant differences in favor of TVC. There was no difference in complications. Quality of life and postoperative sexual function did not show any differences between the two groups. CONCLUSIONS: This is the first study to report HRQoL outcomes after TVC using a recognized combined HRQoL assessment method. Although differences do exist in patient comorbidity and previous surgical experience, both groups were comparable. Less postoperative pain and no difference in HRQoL in TVC patients underlines this new procedure as a feasible standard approach in female patients. This study also is the first to differentiate between acute cholecystitis and symptomatic cholecystolithiasis in patients undergoing TVC.

Effects of coagulation factor XIII on intestinal functional capillary density, leukocyte adherence and mesenteric plasma extravasation in experimental endotoxemia.

INTRODUCTION: The objective of this study was to determine the effects of the administration of the coagulation factor XIII (F XIII) on intestinal functional capillary density, leukocyte adherence and mesenteric plasma extravasation during experimental endotoxemia. METHODS: In a prospective, randomized, controlled animal study 42 male Wistar rats were divided into three groups. Group 1 served as the control group. Groups 2 (lipopolysaccharide (LPS) group) and 3 (F XIII group) received endotoxin infusions (2.5 mg/kg/h for 2 hours). In group 3, 50 U/kg body weight F XIII was continuously administered during the first 30 minutes of endotoxemia. F XIII levels were measured in all animals. One half of the animals of each group were studied for intestinal functional capillary density (FCD) and leukocyte adherence on venular endothelium by intravital fluorescence microscopy (IVM). In the other half of each group, mesenteric plasma extravasation (FITC-albumin) was determined by IVM. RESULTS: The F XIII level was significantly increased in the F XIII treatment group. In the LPS group, endotoxemia led to a significant reduction of mucosal FCD (-18.5%; p < 0.01 versus control group). F XIII administration in the F XIII group attenuated the decrease in mucosal FCD (-3.7% compared to control; p < 0.05 versus LPS group). During endotoxemia, a significant increase of leukocyte adherence at the endothelium could be noted in the LPS group compared to the control group. Leukocyte adherence at the endothelium and plasma extravasation in the F XIII group did not differ significantly from the LPS group. CONCLUSION: Factor XIII protected mucosal capillary perfusion against endotoxin-induced impairment in an experimental sepsis model in rats, whereas leukocyte adherence and plasma extravasation remained unchanged.

Effects of C1 esterase inhibitor administration on intestinal functional capillary density, leukocyte adherence and mesenteric plasma extravasation during experimental endotoxemia.

OBJECTIVE: To determine the effects of C1 esterase inhibitor (C1-INH) administration on intestinal functional capillary density, leukocyte adherence, and mesenteric plasma extravasation during experimental endotoxemia. DESIGN AND SETTING: Prospective, randomized, controlled animal study in the experimental laboratory of a university. SUBJECTS: 42 male Wistar rats. INTERVENTIONS: The animals were divided into three groups. One half of the animals of each group underwent studies of intestinal functional capillary density and leukocyte adherence on venular endothelium by intravital fluorescence microscopy. In the other half of the animals mesenteric plasma extravasation (FITC albumin) was determined by intravital fluorescence microscopy. Treatment groups received endotoxin infusion of 2.5 mg/kg per hour (group 2 and 3) and 100 U/kg b.w. C1-INH (group 3) during the 2 h of endotoxemia. MEASUREMENTS AND RESULTS: Endotoxemia resulted in a significant decrease in mucosal functional capillary density (18.5% vs. controls), which was reduced by C1-INH administration (9.5%). Treatment with C1-INH also significantly attenuated intestinal leukocyte adherence in submucosal venules (35% vs. endotoxin group) and mesenteric plasma extravasation (44% vs. endotoxin group). CONCLUSIONS: C1-INH administration diminishes endotoxin-induced changes in the intestinal microcirculation during experimental endotoxemia.

The barrier-free trocar technique in three laparoscopic standard procedures.

BACKGROUND: Numerous technical and surgical innovations took place in laparoscopic surgery in the recent past. It is debatable whether single-access surgery or natural orifice surgery (NOS) will establish for several standard procedures. Most of the NOS-procedures are controversial and single-access surgery still has to prove its equality in controlled trials. In the intention to reduce the ingress incisons and to facilitate instrumentation, we decided to test the barrier-free AirSeal(®)-trocar in clinical practice. MATERIALS AND METHODS: Laparoscopically we performed a cholecystectomy, gastric wedge-resection and a fundoplication using the barrier-free AirSeal(®) 12-mm-trocar. This trocar works without any mechanical barrier so that via this trocar the use of two instruments is possible. RESULTS: All three operations were successful. CONCLUSION: Laparoscopic standard procedures are feasible using this barrier-free trocar without a higher degree of difficulty. Because of the facilitated instrumentation, it is possible to work more efficiently and to maintain the focus on the surgical field.

Thoracoscopic removal of a transesophageal ingested mediastinal foreign body.

Transesophageal migration of a foreign body into the mediastinum in human adults is rare. This event can result in life-threatening situations and is associated with a high mortality rate. Only a few case reports of thoracoscopic removal of a foreign body in adults have been published so far. The authors describe the case of a successfully performed thoracoscopic approach to remove an ingested needle from the mediastinum posterior of a 69-year-old patient. The authors are discussing why, in similar cases, removal of the foreign body should be performed and they describe the preliminary conditions for this method. A video file is attached.