[Treatment options for peritoneal metastases from hepato-pancreato-biliary tumors and neuroendocrine tumors]. / Therapeutische Optionen bei peritonealer Metastasierung hepatopankreatikobiliärer Tumoren und neuroendokriner Tumoren.

Peritoneal metastasis (PM) in gastroenteropancreatic neuroendocrine tumors (GEP-NET) and hepato-pancreato-biliary (HPB) tumors has a low incidence and has rarely been studied as a stand-alone condition. The clinical relevance of PM in HPB tumors and GEP-NET arises from the fact that PM significantly worsens the prognosis of the underlying tumors. In GEP-NET, the particular situation is that PM has a negative prognostic impact compared to patients without metastases, which is not evident compared to patients with metastases in other locations. Complete surgical cytoreduction (CRS) is a curative treatment option for patients with PM in GEP-NET. Complete surgical resection should always be strived for, although patients may benefit from incomplete resection (70-90%) or resection of the primary tumor alone. Additional hyperthermic chemoperfusion (HIPEC) is currently not recommended. For nonresectable GEP-NET, systemic treatment is available that is oriented to the studies for generally metastasized GEP-NET. For PM in carcinomas of the bile duct and pancreatic carcinomas, there are no valid data or indications for CRS and HIPEC. In contrast, case series for PM in hepatocellular carcinoma (HCC) after CRS or CRS/HIPEC show good survival outcomes that justify a surgical approach under the condition of a complete resection. Patients with PM in GEP-NET and HCC should therefore be referred to a center for peritoneal tumor surgery to evaluate the option of complete CRS and use it as a curative option.

Comparative analysis of postoperative pain after transvaginal hybrid NOTES versus traditional laparoscopic cholecystectomy in obese patients.

PURPOSE: Even though obesity is a known risk factor for needing cholecystectomy, most research excludes patients with higher degrees of obesity. The aim of this retrospective study was to compare postoperative pain and analgesic consumption in obese patients, who underwent either transvaginal hybrid Natural Orifice Transluminal Endoscopic Surgery (NOTES) cholecystectomy (NC) or traditional laparoscopic cholecystectomy (LC). METHODS: Between 12/2008 and 01/2017, 237 NC were performed, of which 35 (14.8%) showed a body mass index (BMI) of 35 kg/m2 or more (obesity II and III according to the World Health Organization). Of these, procedural time, postoperative pain, analgesic requirements, and other early postoperative parameters were collected and compared with 35 matched LC patients from the same time period. RESULTS: There were no differences in the baseline characteristics between the two groups, but we found significant benefits for the hybrid NOTES technique in terms of less pain (P = 0.006), coherent with significantly less intake of peripheral (paracetamol; P = 0.005), and of centrally acting analgesics (piritramide; P = 0.047) within the first two-day post-surgery. We also found that those in the NC group had shorter hospital stays (P < 0.001). The postoperative complication rates and the procedural time did not differ between the two groups. CONCLUSION: With regard to postoperative pain and analgesic requirements and without an increase in postoperative complications, obese patients experience short-term benefits from the hybrid NOTES technique compared to traditional laparoscopic cholecystectomy.

Does a prior hysterectomy complicate transvaginal/transumbilical hybrid NOTES cholecystectomy?-a comparative analysis of prospectively collected data.

PURPOSE: Hysterectomy alters the anatomy of the posterior vaginal vault used as access for transvaginal/transumbilical hybrid NOTES cholecystectomy (NC), creating potential consequences for the feasibility and complication rate of the procedure. Therefore, the aim of our retrospective analysis of prospectively collected data was to analyze the postoperative course after NC in previously hysterectomized (PH) patients compared with patients who had not undergone hysterectomy (NH). METHODS: A total of 126 NH patients and 50 PH patients aged over 42 who had an NC from 12/2008 to 04/2021 were compared regarding age, body mass index (BMI), ASA classification, number of percutaneous trocars, need for intraoperative urinary bladder catheterization, length of procedure, conversion rate, and intraoperative and postoperative complication rate according to the Clavien/Dindo classification, Comprehensive Complication Index (CCI), mortality, and hospital length of stay. RESULTS: PH patients were older than NH patients (63.0 vs 51.5 years; P < 0.001) but did not differ significantly in ASA classification (P = 0.595) and BMI (26.8 vs 27.9 kg/m2; P = 0.480). They required more percutaneous trocars (P = 0.047) and longer procedure time (66.0 vs. 58.5 min; P = 0.039). Out of all 287 scheduled NC only one had to be "converted" to traditional laparoscopic cholecystectomy. Intraoperative and postoperative complication rates, Clavien/Dindo classification, CCI, need for intraoperative urinary bladder catheterization, and length of stay did not differ significantly. CONCLUSION: Our results indicate an increased degree of difficulty of NC in PH patients, although there is no major impact on intraoperative and postoperative complication rates. Urinary bladder perforation is a specific access-related complication in PH patients.

Transvaginal Hybrid-NOTES procedures-do they have a negative impact on pregnancy and delivery?

PURPOSE: We conducted a retrospective observational study in order to identify negative effects of NOTES procedures (Natural Orifice Transluminal Endoscopic Surgery) with transvaginal specimen removal on pregnancy and delivery. METHODS: From the total population of 299 patients in our NOTES registry, we tried to contact the 121 patients who were of reproductive age (≤ 45 years) at the time of a transvaginal NOTES procedure. They were interviewed by telephone regarding their desire for children, post NOTES-operation pregnancies, and type of delivery using a structured questionnaire. The collected data was analyzed and compared with current data. RESULTS: We were able to contact 76 patients (follow-up rate: 62.8%) with a median follow-up of 77 months after surgery (33-129 months). Twenty of 74 participating patients had a desire for children (27.0%). One of them and another's male partner were diagnosed as infertile. Regarding the remaining 18 patients, 14 became pregnant, and three of them became pregnant twice. Considering these 17 pregnancies, there was one miscarriage (5.9%) and one twin birth (5.9%). On average, childbirth occurred 44 months after the NOTES procedure. With regard to the type of delivery, 10 vaginal births (58.8%) and 7 caesarean sections (41.2%) occurred. Thus, the rate of fulfilled desire for children was 77.8%. Compared with the literature, no difference to the normal course could be detected. CONCLUSION: There is no sign that the transvaginal approach in Hybrid-NOTES, with removal of the specimen through the vagina, has a negative effect on conception, the course during pregnancy, or the type of delivery.

Appendicitis during the COVID-19 lockdown: results of a multicenter analysis in Germany.

PURPOSE: The COVID-19 pandemic has transformed medical care worldwide. General surgery has been affected in elective procedures, yet the implications for emergency surgery are unclear. The current study analyzes the effect of the COVID-19 lockdown in spring 2020 on appendicitis treatment in Germany. METHODS: Hospitals that provided emergency surgical care during the COVID-19 lockdown were invited to participate. All patients diagnosed with appendicitis during the lockdown period (10 weeks) and, as a comparison group, patients from the same period in 2019 were analyzed. Clinical and laboratory parameters, intraoperative and pathological findings, and postoperative outcomes were analyzed. RESULTS: A total of 1915 appendectomies from 41 surgical departments in Germany were included. Compared to 2019 the number of appendectomies decreased by 13.5% (1.027 to 888, p=0.003) during the first 2020 COVID-19 lockdown. The delay between the onset of symptoms and medical consultation was substantially longer in the COVID-19 risk group and for the elderly. The rate of complicated appendicitis increased (58.2 to 64.4%), while the absolute number of complicated appendicitis decreased from 597 to 569, (p=0.012). The rate of negative appendectomies decreased significantly (6.7 to 4.6%; p=0.012). Overall postoperative morbidity and mortality, however, did not change. CONCLUSION: The COVID-19 lockdown had significant effects on abdominal emergency surgery in Germany. These seem to result from a stricter selection and a longer waiting time between the onset of symptoms and medical consultation for risk patients. However, the standard of emergency surgical care in Germany was maintained.

Transvaginal hybrid-NOTES vs. traditional laparoscopic sigmoid resection for diverticulitis: a short-term comparative study.

The aim was to compare short-term results of transvaginal hybrid-NOTES (NSR) with traditional laparoscopic technique in sigmoid resection (LSR) in cases of diverticulitis. Natural Orifice Transluminal Endoscopic Surgery has been evolved as a minimally invasive procedure to reduce the operative trauma due to the absence of specimen extraction through the abdominal wall causing less postoperative pain, and shorter hospital stay. Despite the increasing use and published case series of NSR for diverticulitis as a laparoscopic procedure with transvaginal stapling and specimen extraction, there are no studies comparing this procedure with LSR. Twenty NSR patients operated at the Cologne-Merheim Medical Center have been documented and compared with 20 female LSR patients matched for body mass index, American Society of Anesthesiologists-classification (ASA), Hansen/Stock classification, and age. To ensure comparability regarding peri- and postoperative care, only procedures performed by the same surgeon were included. Procedural time, intra- and postoperative complications, conversion rate, postoperative pain, the duration of an epidural catheter, analgesic consumption, and postoperative length of hospital stay were analyzed. There were no significant differences in the sum of pain levels (p = 0.930), length of procedure (p = 0.079), intra- and postoperative complications, as well as duration of an epidural catheter. On the contrary, there were significant positive effects for NSR on morphine requirement at day seven and eight (p = 0.019 and p = 0.035 respectively) as well as the postoperative length of hospital stay (p = 0.031). This retrospective study reveals significant positive effects for NSR compared to LSR regarding length of hospital stay as well as morphine consumption after removal of the epidural catheter, whereas there were no significant differences in complication rate and procedural time. In summary, NSR is an adequate alternative to traditional laparoscopic sigmoid resection considering the surgeons experience and the patient's personal preferences.

The Need for Emergency Laparotomy With Open Abdomen Therapy in the Course of ECMO-A Retrospective Analysis of Course and Outcome.

Background: Abdominal compartment syndrome (ACS) can occur in patients placed on extra corporeal membrane oxygenation (ECMO). This implies the necessity of decompressive laparotomy followed by an open abdomen (OA) to prevent complications such as multi-organ-failure or death. Methods: We searched for ECMO patients in our hospital database between July 2015 and April 2020 and selected those with an emergency laparotomy and OA therapy. Of these, we analyzed only patients who were treated with an OA after establishing the ECMO regarding patient-related parameters like sex, age, height, weight, and indications for ECMO as well as outcome parameters like complete fascial closure rate, mortality, length of stay in intensive care unit (ICU), length and kind of OA therapy, number of surgical procedures, dressing changes concerning negative pressure wound therapy (NPWT), and number of surgical revisions. Results: In eight out of 421 patients (1.9%), a laparostoma had to be created during ECMO support. For temporary closure, either NPWT, abdominal packing, or both were used. The median length of OA therapy was 17 days, and the median length of stay in ICU was 42 days in total. The median number of surgical procedures and NPWT dressing changes was seven. In three of the eight patients, a surgical revision was necessary. The total mortality rate was 50%. In 75%, the fascia could be closed. Two patients died before final closure. In all deceased patients, an abdominal packing was necessary during the course of treatment; in the survivors, only once. No enteroatmospheric fistula or abscesses occurred. Conclusions: ACS in patients placed on ECMO is a very rare condition with a considerable mortality rate but high secondary closure rate of the fascia. A necessary abdominal packing due to a severe bleeding seems to be a risk factor with a potentially fatal outcome.

[Standardized histomorphological processing of peritoneal biopsies as part of the German Peritoneal Biopsy Registry (GRIP, German registry in PD)]. / Standardisierte histomorphologische Aufarbeitung von Peritonealbiopsien im Rahmen des Deutschen Peritonealbiopsieregisters (GRIP, German Registry In PD).

The peritoneal lining of the abdominal cavity consists of a parietal and visceral sheet. The serosa is an interesting organ, which in medical practice is particularly important in the context of chronic peritoneal dialysis (PD). This method of renal replacement therapy utilizes the semipermeability of the peritoneal surface by applying PD solutions of differing osmolarity to eliminate toxic substances and regulate fluid and electrolyte equilibrium. This method is an ideal approach especially for younger patients and is very effective at least for some time. Pre-existing injury to the peritoneum, for example as a consequence of chronic renal insufficiency or associated comorbidities and inflammatory changes that develop during PD, results in a structural remodelling of the serosa. As a consequence, the filtering function of the serosa is lost and PD has to be replaced by another renal replacement therapy. Thorough knowledge of the morphology of peritoneal changes as well as of the risk factors is of paramount importance for therapeutic management and prognosis of PD patients. In order to take this into account, the German Registry In Peritoneal Dialysis (Deutsches Peritonealbiopsieregister, GRIP) was founded a few years ago, which now includes roughly 1700 biopsies, of which detailed clinical and histomorphological information was systematically acquired and collected.

Does obesity influence the results in Transvaginal Hybrid-NOTES cholecystectomy?

BACKGROUND: Morbidly obese patients are usually excluded from studies that compare Transvaginal Hybrid-NOTES Cholecystectomy (TVC) with traditional laparoscopic cholecystectomy. Therefore, these study results cannot necessarily be transferred to this group of patients. In this study, we have analyzed and compared the outcomes of the procedure with obese and non-obese patients. METHODS: Data from a prospectively maintained database were retrospectively analyzed. All the TVCs performed in our clinic since 2008 were divided into groups according to their body mass index (BMI). Within these groups, we evaluated the following outcome parameters: age, ASA classification, procedural time, number of percutaneous trocars, intra- and postoperative complications, and postoperative hospital stay. Additionally, the posthospital surgical and gynecological follow-up was evaluated for additional complications and patients with class III obesity were contacted to determine further parameters. RESULTS: Six underweight, 76 normal weight, 72 overweight, 48 class I obesity, 15 class II obesity, and 20 class III obesity patients were analyzed. ASA classification (P < 0.001), procedural time (P < 0.001), and number of percutaneous trocars (P < 0.001) significantly increased with the BMI. By contrast, intra- and postoperative complications (P = 0.134 and P = 0.571), as well as postoperative hospital stay (P = 0.076) did not depend on the BMI. Neither did the classification according to Clavien/Dindo show a significant relation (P = 0.640). Lethality was zero. All posthospital gynecological follow-ups were inconspicuous. Telephone follow-up of class III obesity patients reached a rate of 85% after median 3.4 years. There were no additional complications or problems during sexual intercourse. The satisfaction with the cosmetic and the overall result was very high. CONCLUSIONS: Although the results of existing studies including normal-weight or merely moderately obese patients can hardly be applied to morbidly obese patients, especially regarding procedural time and the number of percutaneous trocars, obesity should not be an exclusion criterion for TVC, regardless of its magnitude.

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/m vs TGAE: 24.1 kg/m; 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.

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.

Natural Orifice Transluminal Endoscopic Surgery (NOTES) for colon resections--analysis of the first 139 patients of the German NOTES Registry (GNR).

BACKGROUND: The German NOTES registry (GNR) is the largest published database for natural orifice transluminal endoscopic surgery (NOTES) worldwide. Although transvaginal cholecystectomy is the most frequent procedure in the GNR, the number of colorectal resections is increasing. The objective of this study was to analyze the first 139 colonic procedures of the GNR. METHODS: All colonic procedures from the GNR were analyzed regarding patient- and therapy-related parameters. A multivariate analysis was conducted for transvaginal sigmoid resections regarding procedural time, hospital stay, conversion rate, and rate of complications. RESULTS: From October 2008 to January 2013, 139 colon NOTES procedures (12 male, 127 female) were registered. Main diagnoses were sigmoid diverticulitis (85.6 %), colon carcinoma (9.4 %), and ulcerative colitis (3.6 %). Sigmoid resections (87.1 %), proctocolectomies (3.6 %), right-sided resections (2.9 %), left-sided resections (3.6 %), segmental resections (2.2 %), and 1 ileocecal resection (0.7 %) were performed. All procedures were conducted in transvaginal (87.8 %) or transrectal (12.2 %) hybrid technique, with a median of 3 percutaneous trocars. Conversions to laparoscopic technique were necessary in 3.6 % (none to conventional technique). Intraoperative complications were recorded in 2.9 % and postoperative complications in 12.2 %. The institutional case number in transvaginal sigmoid resections correlated negatively with procedural time (p = 0.041) and the number of percutaneous trocars (p = 0.002). CONCLUSION: The analysis of the first 139 colon NOTES operations of the GNR shows the feasibility of co on operations in hybrid technique, especially for transvaginal sigmoid resection as the most frequent procedure.

Long-term results of transvaginal/transumbilical versus classical laparoscopic cholecystectomy--an analysis of 88 patients.

INTRODUCTION: Transvaginal/transumbilical cholecystectomy using rigid instruments (TVC) is an alternative to the traditional laparoscopic technique (LC). Due to a lack of long-term data, the transvaginal approach is still controversial. METHODS: Our first 50 TVC patients and 50 LC patients from the same time period with the same limits according to age, BMI and ASA classification were asked 48 questions 2 years postoperatively (mean) about resuming sexual intercourse, the domains "satisfaction" and "pain" of the German Female Sexual Function Index, resuming everyday life, postoperative abdominal pain, subjective impairment, incisional hernias, satisfaction with the aesthetic result, the overall postoperative result, and others. Postoperative sexual satisfaction and pain were defined as main outcome. Forty-six TVC patients and 42 LC patients answered the questions (36 TVC patients and 25 LC patients could answer the questions about sexual function). RESULTS: No significant differences were found for postoperative sexual function, change in menorrhea, vaginal discharge and postoperative abdominal pain. TVC patients felt significantly less impaired postoperatively (p = 0.034). Two patients in the LC group developed a trocar hernia (p = 0.225). TVC patients could resume everyday life significantly earlier (p < 0.001) and were significantly more satisfied with the aesthetic (p < 0.001) and the overall postoperative result (p = 0.001). Significantly more TVC patients would recommend the applied surgical technique to friends and family (p < 0.001). CONCLUSIONS: This long-time prospective data acquisition from 88 or, for some data, 61 patients accounts for the safety of TVC, particularly with regard to sexual function. Additionally, it found less postoperative impairment, quicker recovery and improved satisfaction for TVC as compared to LC.

Laparoscopy for a ventriculoperitoneal shunt tube dislocated into the colon.

INTRODUCTION: Implantation of a ventriculoperitoneal (VP) shunt is a standard procedure for hydrocephalus. Different complications can occur, one of them being migration of the distal end of the tube. CASE DESCRIPTION: The abdominal end of a VP shunt tube had migrated into the descending colon. In a laparoscopic procedure, the shunt was retrieved, and the colonic perforation site was resected. The patient had a favorable outcome. DISCUSSION: Laparoscopy can play a key role and is recommended not only to make an exact diagnosis, but also for definite, safe, and trauma-minimizing treatment of intraabdominal VP shunt dysfunction.

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

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.

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.