Dirk Rolf Bulian

The German Registry for Natural Orifice Translumenal Endoscopic Surgery: Report of the First 551 Patients

Objective:To analyze patient outcome in the first 14 months of the German natural orifice translumenal endoscopic surgery (NOTES) registry (GNR). Summary Background Data:NOTES is a new surgical concept, which permits scarless intra-abdominal operations through natural orifices, such as the mouth, vagina, rectum, or urethra. The GNR was established as a nationwide outcome database to allow the monitoring and safe introduction of this technique in Germany. Methods:The GNR was designed as a voluntary database with online access. All surgeons in Germany who performed NOTES procedures were requested to participate in the registry. The GNR recorded demographical and therapy data as well as data on the postoperative course. Results:A total of 572 target organs were operated in 551 patients. Cholecystectomies accounted for 85.3% of all NOTES procedures. All procedures were performed in female patients using transvaginal hybrid technique. Complications occurred in 3.1% of all patients, conversions to laparoscopy or open surgery in 4.9%. In cholecystectomies, institutional case volume, obesity, and age had substantial effect on conversion rate, operation length, and length of hospital stay, but no effect on complications. Conclusions:Despite the fact that NOTES has just recently been introduced, the technique has already gained considerable clinical application. Transvaginal hybrid NOTES cholecystectomy is a practicable and safe alternative to laparoscopic resection even in obese or older patients.

Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial.

In a randomized clinical trial, needlescopic 3-trocar cholecystectomy was compared with transvaginal/transumbilical hybrid—NOTES—technique for symptomatic cholecystolithiasis. We found significantly less pain despite less analgesics, increased satisfaction with the aesthetic result, and improved postoperative quality of life in the NOTES group. Furthermore, both techniques were equal in terms of safety.

Analysis of the First 217 Appendectomies of the German NOTES Registry.

Objective: To analyze the feasibility and safety of Natural Orifice Transluminal Endoscopic Surgery (NOTES) appendectomy, and to analyze separately the transvaginal appendectomy (TVAE) and the transgastric appendectomy (TGAE) procedures. Background: Laparoscopic appendectomy has rare but relevant complications, namely incisional hernias and neuralgia at the trocar sites, which can potentially be avoided by the NOTES techniques. Methods: The first 217 data sets of the largest NOTES registry worldwide—the German NOTES registry—were analyzed with respect to demographic data, procedural data, and short-term outcomes. Furthermore, TVAEs were compared with TGAEs. Results: Almost all procedures were performed in hybrid technique (median of percutaneous trocars: 1). Median age (TVAE: 30.5 yrs vs TGAE: 25 yrs; P < 0.017), body mass index (TVAE: 22.8 kg/m2 vs TGAE: 24.1 kg/m2; P < 0.016), and American Society of Anesthesiologists (ASA) classification (I/II/III; TVAE: 57.1%/41.8%/1.0% vs TGAE: 27.8%/69.4%/2.8%; P < 0.003) significantly differed between both access techniques. Whereas the median number of percutaneous trocars (TVAE: 1 vs TGAE: 1; P < 0.450), the need of additional trocars (TVAE: 6.6% vs TGAE: 13.9%; P < 0.156), the intra, and also postoperative rate of complications (TVAE: 0%/5.5% vs TGAE: 0%/11.1%; P < 1.000/0.258), and the median postoperative hospital stay (TVAE: 3 d vs TGAE: 3 d; P < 0.152) were comparable; the median procedural time (TVAE: 35 minutes vs TGAE: 96 minutes; P < 0.001) and conversion to laparotomy rate (TVAE: 0% vs TGAE: 5.6%; P < 0.023) were significantly less after TVAE. Conclusions: The evaluation of the largest patient collective so far indicates that hybrid NOTES appendectomy is a safe procedure, with advantages for the transvaginal technique with respect to procedural time and conversion rate.

Clinical efficacy of cytoreductive surgery and hyperthermic chemotherapy in peritoneal carcinomatosis from gastric cancer.

Evaluation of: Yang XJ, Huang CQ, Suo T et al. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a Phase III randomized clinical trial. Ann. Surg. Oncol. 18(6), 1575–15781 (2011). Peritoneal carcinomatosis (PC) is the most common pattern of metastasis and recurrence in patients with gastric cancer and is associated with poor clinical outcome and survival. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) was recently established as a new treatment option for PC of gastrointestinal cancer. However, the role of cytoreductive surgery in gastric cancer and the intrinsic role of HIPEC remains unclear. The evaluated article presented a single center Phase III study, randomizing 68 patients with PC from gastric cancer to surgical cytoreduction only (CRS; n = 34) versus cytoreduction plus HIPEC with cisplatin and mitomycin (CRS+HIPEC; n = 34). Median overall was 6.5 months in the CRS group and 11.0 months in the CRS+HIPEC group (p = 0.046). Serious adverse events were acceptable in both groups. Multivariate analysis found CRS+HIPEC, synchronous PC, complete cytoreduction, systemic chemotherapy >6 cycles and no incidence of severe adverse events independent predictive factors for survival. This was the first study to show the positive effects of HIPEC in addition to CRS in PC independently of the tumor entity. In patients with gastric cancer, multimodal treatment concepts combining surgical cytoreduction and HIPEC may provide a new option in carefully selected patients.

Systematic analysis of the safety and benefits of transvaginal hybrid-NOTES cholecystectomy.

AIM To evaluate transvaginal hybrid-NOTES cholecystectomy (TVC) during its clinical establishment and compare it with the traditional laparoscopic technique (LC). METHODS The specific problems and benefits of TVC were reviewed using a registry analysis, a comparative cohort study and a randomized clinical trial. At first, feasibility, safety and specific complications of the TVC were analyzed based on the first 488 data sets of the German NOTES Registry (GNR). Hereafter, we compared the early postoperative results of our first 50 TVC-patients with those of 50 female LC-patients matched by age, BMI and ASA classification. The same cohort was contacted an average of two years later to evaluate long-term results concerning pain and satisfaction with the aesthetic results and the overall postoperative results as well as sexual intercourse by means of two domains of the German version of the Female Sexual Function Index (FSFI-d). Consequently, we performed a randomized clinical trial comparing 20 TVC-patients with 20 needlescopic/3-trocar cholecystectomies (NC) also concerning the early postoperative results as well as pain, satisfaction and quality of life by means of the Eypasch Gastrointestinal Quality of Life Index (GIQLI) in the later course. Finally, we discussed the results in accordance with other published studies. RESULTS The complication (3.5%) and conversion rates (4.1%) for TVC were low in the GNR and comparable to those of the LC. Access related intraoperative complications included injuries to the bladder (n = 4; 0.8%) and bowel (n = 3; 0.6%). The study cohort revealed less postoperative pain after TVC comparing to the LC-patients on the day of surgery (NRS, 1.5/10 vs 3.1/10, P = 0.003), in the morning (NRS, 1.9/10 vs 2.8/10, P = 0.047) and in the evening (NRS, 1.1/10 vs 1.8/10, P = 0.025) of postoperative day (POD) one. The randomized clinical trial consistently found less cumulative pain until POD 2 (NRS, 8/40 vs 14/40, P = 0.043), as well as until POD 10 (NRS, 22/190 vs 41/190, P = 0.010). Furthermore, the TVC-patients had a better quality of life on POD 10 than did the LC-patients (GIQLI, 124/144 vs 107/144, P = 0.028). The complication rates were comparable and no specific problems were detected in the long-term follow-up for sexual intercourse for either group. The TVC-patients were more satisfied with the aesthetic result in the long-term course in the matched cohort analysis (1.00 vs 1.88, P < 0.001) as well as in the randomized clinical trial (1.00 vs 1.70, P < 0.001) when compared with the LC-patients. CONCLUSION TVC is a feasible procedure with a high safety profile and has advantages in regard to postoperative pain and aesthetic results when compared with LC or NC.

Relative lymphocyte count is a prognostic parameter in cancer patients with catumaxomab immunotherapy

BACKGROUND Catumaxomab (anti-EpCAM × anti-CD3) treatment in peritoneal carcinomatosis (PC) of EpCAM-positive cancers was effective in phase I and II studies. Recently, it was approved in the EU for treatment of peritoneal carcinomatosis and malignant ascites. Aim of this hypothesis-generating study was to identify predictive or prognostic biomarkers with relevance for overall survival. METHODS 34 patients with PC in phase I/II studies with catumaxomab treatment were assessed for age, Karnofsky Index (KI), relative (RLC) and absolute lymphocyte count, relative and absolute granulocyte count, T-cell subsets, NK cells, and monocytes before catumaxomab therapy. Disease control (responder) was defined by stable disease, partial response or complete response (RECIST v1.0) >3 months or survival >6 months. Correlation analysis, Kaplan-Meier curves, ROC calculation, and multivariate regression were used for statistical analysis. RESULTS Mean RC values significantly differed between the non-responder (14.0%) and the responder group (23.9%; p=0.001). RLC was correlated with overall survival (p=0.03). RLC of >12% defined by ROC calculation was associated with prolonged survival (p=0.035; hazard ratio of 2.775 for patients with RLC <12%). Patients with RLC >12% showed a mean survival of 15.6 versus 5.6 months in patients with RLC ≥ 12% (p=0.001). Multivariate analysis found the individual RLC before therapy (p=0.039) and the KI performance status (p=0.002) to be independent prognostic parameters. Increasing KI by 1% resulted in a risk decrease of 10.1%. Increasing RLC by 1% resulted in a risk decrease of 4.6%. Age and the extent of PC did not significantly influence survival. CONCLUSIONS RLC and KI were identified as potential prognostic parameters for superior disease control and overall survival after catumaxomab treatment. RLC may be used as a biomarker to indicate a suitable immune status for catumaxomab therapy. The predictive impact has to be confirmed in further studies.

Laparoscopy for a ventriculoperitoneal shunt tube dislocated into the colon.

Laparoscopy can be an effective tool for the diagnosis and management of intra-abdominal ventriculoperitoneal shunt dysfunction.

Invited commentary on “Werkgartner G. et al.: laparoscopic versus open appendectomy for complicated appendicitis in high risk patients”

The authors discuss a very important and controversial topic: Is laparoscopic appendectomy for complicated appendicitis in high-risk patients with an ASA score of 3 or 4 associated with a justifiable risk? Compared to open appendectomy, is the risk comparable or even less? On the one hand, the risk of postoperative complications in multimorbid patients is increased. On the other hand, the question is, whether or not the laparoscopic technique further and unnecessarily increases that risk. To answer these questions, the authors retrospectively analyzed the appendectomies from their institution over a course of 8 years and extracted those patients with both complicated appendicitis and ASA score of 3 or 4. These were then analyzed after having been divided into two groups, namely open and laparoscopic procedures. A conversion rate is not available. Evaluated preoperative parameters were age, gender, and comorbidities, Leucocyte count, CRP, ASA score, and fever. Documented intraand postoperative parameters were perforation, procedural time, hospital stay, complications rated according to Clavien/Dindo, as well as Leucocyte-count and CRP on the first and third postoperative day. The flaw in this analysis can be seen in the missing comparability of the two groups. The choice of operative technique was left to the surgeons and was definitely influenced by the comorbidities. As the authors state, conventional appendectomy is the preferred method in their institution in case of severe cardiac or pulmonary comorbidities. Thus, it does not come as a surprise that these are overrepresented in the OA group. Almost half of the OA patients (45 %) were rated as NYHA IV. According to the authors, this was a contraindication for laparoscopy. Therefore, half of the patients in the OA group would not have been operated upon laparoscopically, which forbids comparison of the two groups. Similar differences between the two groups appear for age and the fraction of the ASA 4 patients. Furthermore, a markedly higher amount of perforations appeared in the OA group. As a conclusion, the significant differences are certainly not based on a statistically randomized pattern, but possibly entirely on differences in both populations. In order to allow a separate influence of the operative technique on the complication rate, a multivariate analysis is needed. However, for this statistical tool, the case number is too low. A multicenter trial is probably the most suitable method to extensively answer the proposed questions. As the authors correctly remark, a prospective, randomized trial would be hard to realize for this topic. Also, especially in a retrospective analysis, utilization of the ASA classification seems questionable, since the ASA classification is too simplistic and highly subjective. However, the authors’ analysis impressively shows that for complicated appendicitis, the laparoscopic technique could be performed in ASA 3/4 patients, excluding those with a NYHA IV score, after subjective selection by the performing surgeon with an acceptable rate of complication in their institution. However, I find that the direct comparison with the open technique is limited for the reasons mentioned above. A further interesting result of the study is that the rise in CRP value in case of a postoperative complication is not as high following a laparoscopic appendectomy as compared to an open procedure. Thus, a complication might take a more concealed course. This deserves further evaluation in future trials.

Erratum to: Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months

1 Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109 Cologne, Germany 2 Department of General, Visceral, Vascular and Thoracic Surgery, Clinic of Kempten, Robert-Weixler-Strasse 50, 87439 Kempten, Germany 3 Department for Obstetrics and Gynecology, Holweide Hospital, Neufelder Strasse 32, 51067 Cologne, Germany Langenbecks Arch Surg DOI 10.1007/s00423-016-1472-6 (2019) 404 (Suppl 1):S25

Repeat Percutaneous Tracheostomy is Safe- A Retrospective Analysis of 15 Cases

Repeat Percutaneous Tracheostomy is Safe- A Retrospective Analysis of 15 Cases We consider redo- percutaneous dilatational tracheostomy an option, despite previous percutaneous dilatational tracheostomy sometimes being considered a contraindication for a redo-procedure. Since data on this issue is limited, we analyzed our respective procedures for evaluation of this matter.