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.

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.

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.

Transanal endoscopic microsurgery in treatment of rectal adenomas and T1 low-risk carcinomas.

BACKGROUND: Transanal endoscopic microsurgery as a local therapy option for rectal neoplasms is a tissue-sparing technique that protects the anal sphincter. The present retrospective analysis reports the course of observation after local excision of adenomas and T1 low-risk carcinomas using transanal endoscopic microsurgery. METHODS: In a retrospective analysis we examined data on 279 patients for local recurrence. A total of 144 patients had a rectal adenoma (n = 103) or a R0 resection of low-risk T1 carcinomas (n = 41). In this collective, we also examined parameters concerning perioperative management, complications, intraoperative blood loss and duration of hospital stay. RESULTS: Patients with adenoma were on average 64.9 (range 37 to 90) years old; 83.5% of the adenomas were located 3 to 11 cm from the anocutaneous line. In adenoma patients the recurrence rate was 2.9% for an observation period of 21.8 months. The postoperative course was without any complications in 98.1% of patients.Patients with T1 low-risk carcinoma were 64.6 (range 30 to 89) years old. In all cases, an R0 resection could be performed. The recurrence rate was 9.8% for an observation period of 34.4 months. In this group the postoperative course was free of complications in 97.6% of patients. CONCLUSIONS: The high efficacy of transanal endoscopic microsurgery ensures minimally invasive treatment of adenomas and low-risk T1 carcinomas with low complication rates and a low rate of therapeutic failure.

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 video-assisted cholecystectomy in clinical practice.

BACKGROUND: Transvaginal video-assisted cholecystectomy with rigid instruments is a new procedure that combines natural orifice surgery (NOS) with classic laparoscopy. This hybrid technique requires conventional laparoscopy via an umbilical incision. To date it is unclear if this procedure is safe and feasible in routine practice. METHODS: We report on a case series of 128 women who consented to transvaginal cholecystectomy. Data, including visual analog scores (VAS), were collected prospectively via a standard digital spreadsheet. Patients completed satisfaction questionnaires within 10 days after discharge from hospital. We report on outcomes, age, body mass index, operating time, complications, pain scores, and patient satisfaction. RESULTS: In 115 (89.8%) patients the procedure was performed as a transvaginal operation. In 11 women (8.6%), we converted to standard laparoscopy, and in 2 cases (1.6%), we converted to an open procedure. Mean age was 52.4 years (range = 23-78 years) and mean body mass index was 27.8 (range = 18.8-42). Mean operating time was 60.6 min (range = 22-110 min). Other procedures were combined with hybrid cholecystectomy in six cases. Complications following transvaginal access included one vaginal bleeding, one perforation of the urinary bladder, and one superficial lesion of the rectum. In one case the hepatic duct had to be stented due to leakage after the procedure via endoscopic retrograde cholangiography. Mean VAS on day 1 was 2.26 (± 0.31 SEM) and on day 2 it was 1.53 (± 0.35 SEM). In a postoperative questionnaire, 95% of patients indicated that they would recommend this procedure to other patients. CONCLUSIONS: Transvaginal cholecystectomy is a safe and easy-to-learn procedure. Possible complications are different than those of standard laparoscopic procedures. Trauma to the abdominal wall and scarring is minimal. Postoperative pain scores were not different than those of standard laparoscopy and a high percentage of patients are satisfied with the procedure.

International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients.

OBJECTIVES: Natural orifice translumenal endoscopic surgery (NOTES) is evolving as a promising alternative for abdominal surgery. IMTN Registry was designed to prospectively document early results of natural orifice surgery among a large group of clinical cases. METHODS: Sixteen centers from 9 countries were approved to participate in the study, based on study protocol requirements and local institutional review board approval. Transgastric and transvaginal endoscopic natural orifice surgery was clinically applied in 362 patients. Intraoperative and postoperative parameters were prospectively documented. RESULTS: Mean operative time for transvaginal cholecystectomy was 96 minutes, compared with 111 minute for transgastric cholecystectomy. A general complication rate of 8.84% was recorded (grade I-II representing 5.8%, grade III-IV representing 3.04%). No requirement for any analgesia was found in one fourth of cholecystectomy and appendectomy patients. CONCLUSIONS: Results of clinical applications of NOTES in the IMTN Study showed the feasibility of different methods of this new minimally invasive alternative for laparoscopic and open surgery.

Novel technologies for natural orifice surgery: an overview.

Natural Orifice Surgery (NOS) is now being elaborated with the aim to make abdominal surgery simpler and safer. The existing natural openings of the body are used for introduction of surgical instruments and thus to perform surgical procedures while avoiding to penetrate the abdominal wall. Actually, the transvaginal and transgastric approaches are the common routes used for NOS applications in humans. The transvaginal approach does not necessitate any sophisticated devices for opening and closure of the posterior colpotomy, thus being easy for the surgeon and safe for the patient. In contrast, the problem of transluminal access and closure represents significant obstacles in the transgastric approach and is still unsolved. In order to achieve this goal, various surgical prototype devices have been developed. This article aims to give an overview on the current status of techniques and technologies that are being developed and applied in conjunction with NOS procedures.

Transanal endoscopic microsurgery (TEM): a new technique and development during a time period of 20 years.

The technique of transanal endoscopic microsurgery (TEM) was made available for clinical use in 1983. To our knowledge, this technique is currently the only one-port system in endoscopic surgery by which a direct endoluminal approach to the target organ by using a natural opening of the body. Use of the stereoscopic view also is unique in procedures performed routinely. The first indication for use of this new technique was excision of rectal adenomas. It provided the potential of low complications and low recurrence rates compared with the conventional surgical procedures. With the development of endorectal ultrasound for staging, and because many adenomatous polyps contained early rectal cancer, the question arose as to how to deal with these patients after successful local excision. Studies showed that the indication for use of the TEM-technique was extended to early, good differentiated rectal cancer-so-called, low-risk rectal cancer. Many studies showed that the TEM-technique is the optimal operation to avoid complications for patients with rectal polyps and low-risk pT1 tumours of the rectum. The main problem remains regarding how to identify these patients preoperatively and separate them from those who already have a high risk of local recurrence and lymph node metastasis at the time of operation. The effectiveness of any preoperative or postoperative combined treatment to reduce the risk of local recurrence and lymph node metastasis remains unclear. Combined treatment could be a future option to also cure more advanced cancer. Currently, the TEM-technique is the only endoscopic technique that uses a natural opening to reach the target organ, and is a valuable surgical technique with a low complication rate for patients with adenomatous rectal tumours and early rectal cancer.

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.

Epidemiology of inflammatory bowel disease in a German twin cohort: results of a nationwide study.

BACKGROUND: Genetic predisposition as a cause of inflammatory bowel disease (IBD) has been proven by both family and twin studies and genetic variants associated with the disease have been identified. The aim of our study was to determine the concordance rates for IBD in German twin pairs and to evaluate clinical characteristics of concordant and discordant twin pairs. METHODS: Patients with IBD were asked to participate and complete a questionnaire that contained questions about zygosity, demographic data, and medical history. RESULTS: A total of 189 twin pairs in which at least 1 member had IBD were recruited (68 monozygotic and 121 dizygotic pairs). Within monozygotic pairs, 11 out of 31 (35%) were concordant for Crohn's disease (CD) and 6 out of 37 (16%) for ulcerative colitis (UC). Two of the 58 (3%) dizygotic pairs with CD and 1 out of 63 (2%) dizygotic pairs with UC were concordant for the disease. In 14 out of 20 (70%) discordant monozygotic CD pairs and 25 out of 31 (81%) discordant monozygotic pairs with UC, the first-born was affected by IBD. For discordant dizygotic twins, the first in birth order had IBD in 33 out of 56 (59%) pairs with CD and 40 out of 62 (64.5%) pairs with UC. CONCLUSIONS: This study confirms a stronger genetic influence in CD than in UC. The high preponderance in being affected of the first-born twin and the fact that concordance was only 35% for CD and 16% for UC monozygotic twins highlight the important role of environmental trigger factors.