Euro-NOTES Status Paper: from the concept to clinical practice.

BACKGROUND: The concept of natural orifice transluminal endoscopic surgery (NOTES) consists of the reduction of access trauma by using a natural orifice access to the intra-abdominal cavity. This could possibly lead to less postoperative pain, quicker recovery from surgery, fewer postoperative complications, fewer wound infections, and fewer long-term problems such as hernias. The Euro-NOTES Foundation has organized yearly meetings to work on this concept to bring it safely into clinical practice. The aim of this Euro-NOTES status update is to assess the yearly scientific working group reports and provide an overview on the current clinical practice of NOTES procedures. METHODS: After the Euro-NOTES meeting 2011 in Frankfurt, Germany, an analysis was started regarding the most important topics of the European working groups. All prospectively documented information was gathered from Euro-NOTES and D-NOTES working groups from 2007 to 2011. The top five topics were analyzed. RESULTS: The statements of the working group activities demonstrate the growing information and changing insights. The most important selected topics were infection issue, peritoneal access, education and training, platforms and new technology, closure, suture, and anastomosis. The focus on research topics changed over time. The principle of hybrid access has overcome the technical and safety limitations of pure NOTES. Currently the following NOTES access routes are established for several indications: transvaginal access for cholecystectomy, appendectomy and colon resections; transesophageal access for myotomy; transgastric access for full-thickness small-tumor resections; and transanal/transcolonic access for rectal and colon resections. CONCLUSIONS: NOTES and hybrid NOTES techniques have emerged for all natural orifices and were introduced into clinical practice with a good safety record. There are different indications for different natural orifices. Each technique has been optimized for the purpose of finding a safe and realistic solution to perform the procedure according to the specific indication.

Transvaginal NOTES hybrid cholecystectomy: feasibility results in 68 cases with mid-term follow-up.

BACKGROUND AND STUDY AIMS: Natural orifice transluminal endoscopic surgery (NOTES) has been tested in the animal model for a multitude of procedures including cholecystectomy. Clinical experience using flexible endoscopes is, however, very limited. Transvaginal cholecystectomy has been shown to be the most feasible approach in which rigid instruments can be used. We report our experience in all patients treated over a 1-year period. PATIENTS AND METHODS: Between June 2007 and June 2008, 68 patients (mean age 50 years) underwent transvaginal cholecystectomy with an additional 5-mm umbilical trocar using rigid laparoscopic instruments. Data about symptoms, operation, and postoperative course were prospectively collected, as were findings of a gynecological follow-up examination 1 week after surgery and the results of an interview at least 3 months after surgery. RESULTS: All 68 operations were finished successfully without conversion, with a mean operation time of 51 minutes; in three additional cases severe pelvic adhesions prevented further transvaginal progress. There were no intraoperative or immediately postoperative complications, but one patient presented with a Douglas pouch abscess 3 weeks after surgery. Gynecologic follow-up exams 1 week after surgery were unremarkable. All patients were interviewed 3-10 months after surgery and had no abdominal or gynecological complaints including in relation to sexual intercourse. CONCLUSION: Transvaginal NOTES cholecystectomy with rigid instruments can be safely and effectively performed in daily routine.

Laparoscopic fundoplication: Nissen versus Toupet two-year outcome of a prospective randomized study of 200 patients regarding preoperative esophageal motility.

OBJECTIVE: To determine the influence of preoperative esophageal motility on clinical and objective outcome of the Toupet or Nissen fundoplication and to evaluate the success rate of these procedures. Nissen fundoplication (360 degrees ) is the standard operation in the surgical management of gastroesophageal reflux disease (GERD). In order to avoid postoperative dysphagia it has been proposed to tailor antireflux surgery according to pre-existing esophageal motility. Postoperative dysphagia is thought to occur more commonly in patients with esophageal dysmotility and it has been recommended to use the Toupet procedure (270 degrees ) in these patients. We performed a randomized trial to evaluate this tailored concept and to compare the two operative techniques concerning reflux control and complication rate (dysphagia). METHODS: 200 patients with GERD were included in a prospective, randomized study. After preoperative examinations (clinical interview, endoscopy, 24-hour pH-metry and esophageal manometry) 100 patients underwent either a laparoscopic Nissen procedure (50 with and 50 without motility disorders), or Toupet (50 with and 50 without motility disorders). Postoperative follow-up after two years included clinical interview, endoscopy, 24-hour pH-metry, and esophageal manometry. RESULTS: After two years 85% (Nissen) and 85% (Toupet) of patients were satisfied with the operative result. Dysphagia was more frequent following a Nissen fundoplication compared to Toupet (19 vs. 8, p < 0.05) and did not correlate with preoperative motility. Concerning reflux control the Toupet proved to be as good as the Nissen procedure. CONCLUSION: Tailoring antireflux surgery according to the esophageal motility is not indicated, as motility disorders are not correlated with postoperative dysphagia. The Toupet procedure is the better operation as it has a lower rate of dysphagia and is as good as the Nissen fundoplication in controlling reflux.

Scarless cholecystectomy with combined transvaginal and transumbilical approach in a series of 20 patients.

BACKGROUND: Laparoscopic surgery has dramatically improved surgical care of patients reducing postoperative pain, wound infection rate, hospital stay, inability to work, risk of hernia, and cosmetic result. Natural orifice transluminal endoscopic surgery (NOTES) is even less traumatic to the abdominal wall and might further improve minimal invasive surgery of patients, but might also increase surgical risk when used by a transgastric or transcolonic approach with flexible endoscopes. Therefore we decided to use a transvaginal approach using rigid laparoscopic instruments for cholecystectomies. METHODS: Through a 5-mm incision deep in the umbilicus a pneumoperitoneum was created. The optic and a dissector were inserted through the posterior fornix of the vagina under laparoscopic control from the umbilicus and a transvaginal gallbladder removal was performed. RESULTS: 20 patients were successfully operated in a 4.5-month period. Operating time was 62 (35-100) min. No intra- or postoperative complications occurred in any patient. Gynecological examination after 8 days showed no negative findings and the cosmetic result was ideal with no visible scars. CONCLUSION: In our series we showed that cholecystectomies can be routinely performed in a NOTES technique without visible scar. The transvaginal approach is the safe in NOTES and common laparoscopic instruments can be used as long as there are no better flexible endoscopes for this purpose.

Laparoscopic cholecystectomy without visible scar: combined transvaginal and transumbilical approach.

Laparoscopic surgery has decreased trauma and improved results and natural orifice transluminal endoscopic surgery (NOTES) should be a further step in this direction. However the use of flexible gastroscopes in the abdomen is difficult and the generally chosen transgastric approach is not without risk. Therefore we have carried out a cholecystectomy with a combined transvaginal and transumbilical approach, using laparoscopic instruments. The optic and a dissector were inserted in the posterior fornix of the vagina, and a 5-mm trocar was inserted deep in the umbilicus. After dissection the gallbladder was removed through the vagina. The operation was done without problems within 85 minutes and left no visible scar. The postoperative course was uneventful. In NOTES the transvaginal approach has important advantages over the transgastric method (e. g. regarding sterilization and closure); standard laparoscopic instruments can be used whilst there are no flexible endoscopes that are easier to handle.

[Natural orifice transluminal endoscopic surgery in Germany: Data from the German NOTES registry]. / "Natural orifice transluminal endoscopic surgery" in Deutschland : Daten aus dem deutschen NOTES-Register.

BACKGROUND: The German NOTES registry (GNR) was initiated by the German Society for General and Visceral Surgery (DGAV) as a treatment and outcome database for natural orifice transluminal endoscopic surgery (NOTES). AIM: The aim of this study was the descriptive analysis of all GNR data collected over a 5-year period since its start in 2008 with more than 3000 interventions. MATERIAL AND METHODS: The GNR is an online database with voluntary participation available to all German-speaking clinics. Demographic data, therapy details, complications and data on the postoperative course of patients are recorded. All cases in the GNR between March 2008 and November 2013 were included in the analysis. RESULTS: From a total of 3150 data sets 2992 (95 %) were valid and suited for the analysis. Hybrid transvaginal cholecystectomy was the most frequently used procedure (88.7 %), followed by hybrid transvaginal/transgastric appendectomy (6.1 %) and hybrid transvaginal/transrectal colon procedures (5.1 %). Intraoperative complications occurred in 1.6 %, postoperative complications in 3.7 % and conversions were reported in 1.5 %. Intraoperative bladder injuries and postoperative urinary tract infections were identified as method-specific complications of transvaginal procedures. Bowel injuries occurred as a rare (0.2 %) but potentially serious complication of transvaginal operations. CONCLUSION: The German surgical community ensures a safe and responsible introduction of the new NOTES operation techniques with its active participation in the GNR. Despite an overall low complication rate, the high number of procedures in the GNR permitted the identification of method-specific complications. This knowledge can be used to further increase the safety of NOTES in practice.

Post-irradiation soft tissue sarcoma.

From 1975 to 1993, 11 of 375 patients treated for soft tissue sarcoma presented with post-irradiation sarcoma. The mean time interval between irradiation therapy and onset of the second neoplasm was 15.8 years (4-31 years). The total radiation dosage ranged from 12 to 60 Gy with a mean of 40 Gy. All patients had complete staging including CT or MRI of the tumour site, and CT of the lung. Surgical resection was the treatment of choice. Wide margins could be achieved in 10 patients. One had a marginal resection. Tumours included malignant fibrous histiocytoma, haemangiosarcoma, rhabdomyosarcoma, malignant schwannoma, fibrosarcoma and undifferentiated sarcoma. All patients were reassessed in our outpatient clinic. After a mean follow-up of 4.7 years (1.0-11.5 years), only 1 patient had died because of the tumour. Although post-irradiation sarcomas are rather infrequently observed, these tumours must be suspected when alterations or symptoms occur in a previously irradiated region. Early detection provides the chance of curative, wide margin resection.

Does malignant transformation of benign soft-tissue tumours occur? A clinicomorphological study of ten initially misdiagnosed soft-tissue sarcomas.

Ten soft-tissue sarcomas out of a consecutive series of 201 neoplasms are described, in which the clinical histories were suggestive of malignant transformation of a benign lesion excised from the same location 2-97 months before. Each of the 10 preceding soft-tissue neoplasms was reviewed histologically and reclassified as either highly (n = 8) or moderately differentiated (n = 2) sarcomas. Irrespective of the primary treatment, these initially misdiagnosed tumours showed an overall better prognosis than the whole group of soft-tissue sarcomas (5- and 10-year survival rates 76% versus 44%, and 52% versus 30% respectively). Their clinical course was, however, characterized by up to 6 (mean 2.9) local recurrences. From the total series of 201 tumours the authors conclude that soft-tissue sarcomas other than malignant schwannomas in the setting of von Recklinghausen's disease only exceptionally, if ever, arise from benign precursors.

Serum levels of vascular endothelial growth factor and basic fibroblast growth factor in patients with soft-tissue sarcoma.

PURPOSE: Vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) have been suggested to be important mediators for tumor-induced angiogenesis. We measured serum VEGF and bFGF levels from patients with soft-tissue sarcomas and correlated serum VEGF and bFGF levels with tumor status at surgery and histological grading. MATERIALS AND METHODS: A group of 18 healthy controls and 85 patients with soft-tissue sarcoma were enrolled in this study. The patients were classified according to tumor status at surgery. Serum levels of VEGF and bFGF were also correlated with histological grading. VEGF and bFGF levels were determined by enzyme-linked immunosorbent assay (Quantikine R&D Systems). RESULTS: Serum VEGF and bFGF levels were significantly elevated in the patient group (VEGF: 580pg/ml, bFbF: 21pg/ml, P = 0.0001). The highest concentrations of serum VEGF and bFGF were found in patients with macroscopic tumor lesions or G3 histology. Serum VEGF levels showed a statistically significant correlation with tumor status and grading (P = 0.006 for tumor status, P = 0.0001 for grading). CONCLUSIONS: This study reveals that elevated preoperative serum VEGF and bFGF levels can be detected in the majority of patients with soft-tissue sarcoma. The significant correlation with tumor mass and histological grading suggests that a consecutive monitoring of VEGF and bFGF in the serum of patients with soft-tissue sarcoma might be a valuable marker for tumor follow-up.

Survival in patients with primary soft-tissue sarcomas treated within 6 years.

Since 1988, treatment strategies for our sarcoma patients have been determined by the same team and operations performed by one surgeon. The aim of this study was to analyse prognostic data on local recurrence and survival of 101 consecutive patients who presented in our institution with the primary tumour manifestation. After a median follow-up of 35 months, the local recurrence rate was 13.5%, the mean survival time was 68 months and the 5-year survival rate was 83%. Besides positive lymph nodes (only 3 patients) the quality of resection significantly influenced local recurrences (P < 0.05). Univariate predictors of mortality were tumour grade (P < 0.01), tumour size (P < 0.05), distant metastases (P < 0.01), and resection quality (P < 0.01). Multivariate predictors of mortality consisted of grade (P < 0.0001), positive lymph nodes (P < 0.001) and resection quality (P < 0.01). In this homogeneous group of patients, excellent recurrence and survival rates could be achieved. An optimized surgical treatment not only reduces the rate of local recurrences but also augments survival time.

Cytogenetic studies in malignant fibrous histiocytoma.

Among soft tissue sarcomas, malignant fibrous histiocytoma is considered to be the most commonly encountered tumor-type of late adult life. Cytogenetic data are, however, sparse and contradictory, without any specific anomalies. We are describing the results of cytogenetic studies in 20 malignant fibrous histiocytomas of various subtypes and gradings. Although we saw two single and therefore possibly primary rearrangements, t(13;14) and t(5;7), most tumors had complex rearrangements without sharing any characteristic aberrations. In our opinion, the heterogeneity of these findings supports the concept that malignant fibrous histiocytoma is not a distinctive entity but merely a name for a group of as yet poorly defined sarcomas.

Treatment results obtained in metastatic soft-tissue sarcoma with a combination of doxorubicin and dacarbazine or doxorubicin and ifosfamide.

Between 1982 and 1986, 38 patients with soft-tissue sarcomas were treated with the combination doxorubicin/dacarbazine (group A); between 1986 and 1990, another 46 patients received doxorubicin/ifosfamide (group B); and between 1990 and 1991, 11 patients received an alternating regimen of doxorubicin and ifosfamide (group C). The patients' characteristics were comparable among the three groups. Overall remission rates were 34% in group A, 44% in group B, and 18% in group C. The duration of remission was 10 months and the median survival was 13 months in groups A and B. Toxicity, especially myelotoxicity, was severe, with no marked differences being noted between the groups. We conclude that both doxorubicin/dacarbazine and doxorubicin/ifosfamide are active regimens in metastatic soft-tissue sarcomas; nevertheless, the overall prognosis for these patients remains poor.

Malignant haemangiopericytoma of the chest wall.

A patient with malignant haemangiopericytoma of the right second rib is described. En-bloc resection of this rare tumour with the adjacent upper lobe of the lung and part of the chest wall could be achieved. The clinical and morphologic features of this case are presented. On account of the high risk of local recurrence and distant metastasis, we think an adjuvant chemo- and radiotherapy is indicated.

Retroperitoneal sarcoma in a series of 51 adults.

Fifty-one patients with retroperitoneal sarcoma underwent surgery at the University Clinics of Hamburg from 1970 to 1988. Malignant schwannoma, liposarcoma and malignant fibrous histiocytoma were the most common histological types. High grade sarcomas (G3) predominated (42%), while 26% were graded G2 and 33% G1. Complete resection was possible in 59% of cases. Reoperation for local recurrence and debulking in case of not completely resectable disease was common. Regional lymph node metastasis was found in 20% of cases. The peritoneum was the preferred location of metastatic spread. All adjuvant chemotherapies were followed by tumour recurrences. After adjuvant radiotherapy three of six patients remained free of disease. In cases of residual tumour we observed few partial responses on chemo- and radiotherapy, and all patients died because of the disease. The mean survival time was 60 months, the 5- and 10-year survival rates were 35% and 15%, respectively. Factors influencing prognosis in univariate analysis included grade, size, resectability, presence of metastatic spread, histological type, microscopic local growth (infiltrative vs intact pseudocapsule of fibrous tissue) and local recurrence. With multivariate analysis grade, size and lymph node metastasis retained their prognostic significance.

Nissen vs Toupet laparoscopic fundoplication.

BACKGROUND: Nissen fundoplication (360 degrees ) is the standard operation for the surgical management of gastroesophageal reflux disease (GERD). To avoid postoperative dysphagia, it has been proposed that antireflux surgery be tailored according to the degree of preexisting esophageal motility. Postoperative dysphagia is thought to occur more commonly in patients with esophageal dysmotility and the Toupet procedure (270 degrees ) has been recommended for these patients. We performed a randomized trial to evaluate this tailored concept and to compare the two operative techniques in terms of reflux control and complication rate (dysphagia). Our objective was to determine the impact of preoperative esophageal motility on the clinical and objective outcome, following Toupet vs Nissen fundoplication and to evaluate the success rate of these procedures. METHODS: From May 1999 until May 2000, 200 patients with GERD were included in a prospective randomized study. After preoperative examinations (clinical interview, endoscopy, 24-h pH study and esophageal manometry), 100 patients underwent either a laparoscopic Nissen (50 with and 50 without motility disorders), or a Toupet procedure (50 with and 50 without motility disorders). Postoperative follow-up after 4 months included clinical interview, endoscopy, 24-h pH study and esophageal manometry. RESULTS: Interviews showed that 88% (Nissen) and 90% (Toupet) of the patients, respectively, were satisfied with the operative result. Dysphagia was more frequent following a Nissen fundoplication than after a Toupet (30 vs 11, p <0.001) and did not correlate with preoperative motility. In terms of reflux control, the Toupet proved to be as effective as the Nissen procedure. CONCLUSION: Tailoring antireflux surgery to esophageal motility is not indicated, since motility disorders are not correlated with postoperative dysphagia. The Toupet procedure is the better operation because it has a lower rate of dysphagia and is as effective as the Nissen fundoplication in controlling reflux.

[Current indications for angiography of tumors of the muscular and skeletal systems]. / Aktuelle Indikationen zur Angiographie von Tumoren des Muskel- und Skelettsystems.

CT and MRI have greatly influenced the indications for angiography as a diagnostic method for tumours of the muscular and skeletal systems. 59 patients with bone and soft tissue tumours were examined by arteriography (DSA) and the indications for arteriography were compared with CT (32 cases) and MRI (15 cases). Particular attention was paid to the presence of vessel encasement. Arteriography is the definitive method for demonstrating vascular involvement. Tomographic methods demonstrate the topographic relationships of the tumour and neuro-vascular structures. Angiography can also be used as an interventional measure pre-operatively or for palliative embolisation.

Primary sarcoma of the liver in the adult. Report of five surgically treated patients.

During the 5-year period between 1988 and 1989, five patients with primary sarcomas of the liver underwent surgery. Since the patients presented in an early stage of the tumor, all the sarcomas were resectable, in three cases with wide margins (R-0 resection). Five histological types were detected: malignant hemangiopericytoma, malignant fibrous histiocytoma, hemangiosarcoma, rhabdomyosarcoma, and embryonal sarcoma. Two patients with high-grade sarcomas received adjuvant chemotherapy. The follow-up was favorable in three patients with R-0 resections (two had adjuvant chemotherapy). They were still alive, with no evidence of disease 30, 46, and 63 months after the diagnosis. The two other patients had to be reoperated on for local recurrences. Both died of their tumor disease, 30 and 35 months after the initial diagnosis. Extensive chemotherapy in one of these cases failed to arrest tumor progression. Hence, liver resection with wide margins is a very important measure in such cases.

[Technics and complications in reinterventions on the thyroid]. / Technik und Komplikationen bei Rezidiveingriffen an der Schilddrüse.

In preference to the two long-established operative procedures for recurrent goitre - extracapsular and intracapsular resection - we have introduced meticulous preparation between the thin capsule around the recurrent goitre and the more solid external capsule in a procedure which combines the advantages of both older methods and avoids most of their pitfalls. The recurrent laryngeal nerves and the parathyroids are always outside the external capsule. The incidence of injury to these structures is minimised by this procedure. From 1980-1985 we performed 2575 thyroid operations, of which 165 operations were for recurrent goitre (6.4%), bilateral in 89 cases. Two patients died of cardiopulmonary complications (1.2%). Preoperative laryngeal nerve palsy was present in 21 cases, postoperative acquired nerve injuries occurred in 28 patients, all in all 31 nerve paralysis (18.8%), or 12.2% when compared with nerves at risk. Eight patients suffered laryngeal nerve palsy on both sides (five with preoperative nerve palsy on one side). Eleven patients showed normal function of laryngeal nerves on follow-up, whilst permanent nerve palsy was found in seventeen cases (10.3%), or 6.7% when related to nerves at risk. Hypoparathyroidism was found in 7 patients of which 4 cases showed permanent changes (2.4%).

[The necessity of intraoperative identification of the contralateral lobe in "struma uninodosa"]. / Die Notwendigkeit der intraoperativen Darstellung des kontralateralen Lappens bei "Struma uninodosa".

Between July 1st, 1988 and July 31st, 1989 we registered 74 consecutive patients with a unilateral goitre. In all these patients the preoperative sonography showed no pathologic finding in the contralateral lobe of the thyroid. In 16 cases we found and resected nodules in the lobe, which was supposed to be normal. A consequent exposure of the whole thyroid gland, independent of the preoperative sonographic finding, principally is necessary. So, the rate of "false" goitre recurrences might be decreased.

[Limited radical approach in differentiated thyroid gland cancers. A prospective study of 107 patients]. / Eingeschränkte Radikalität bei differenzierten Schilddrüsencarcinomen. Eine prospektive Studie an 107 Patienten.

From 1979 until 1987 a prospective study about limited radical therapy of 107 patients with differentiated cancer of the thyroid was performed. Nearly all of the tumors were occult papillary or encapsulated papillary and follicular carcinomas. The thyroid was not completely resected. Postoperative therapy consisted in TSH-suppression. After a follow-up of 7.5 (5-12) years one patient had died because of the tumor disease. Four patients had to be reoperated for lymph node metastases and then stayed free of disease as all other patients.