When You Operate on Friends and Relatives: Results of a Survey among Surgeons.

OBJECTIVE: We designed a questionnaire to collect data on surgeons' views and experiences of operating on friends or relatives. SUBJECTS AND METHODS: A link to a 38-item online survey was sent to all 16,849 members of the Professional Board of German Surgeons (Bund Deutscher Chirurgen, BDC) several times. Standard interview software was used. The questionnaire collected a wide variety of information concerning how surgeons have experienced, think about, and deal with the situation when they operate on friends or relatives. RESULTS: Of the 16,849 BDC members notified of the survey, 1,643 completed the questionnaires (9.8%). Of these, 1,275 (77.6%) had previously performed surgery on friends or relatives. Overall, the surgeons willingly accepted doing so without experiencing any difficulties. However, the surgeons frequently used different techniques when operating on friends and relatives (123 [10%] when self-assessed compared to 527 [35%] when observed by others). Out of the whole sample, 506 (30.8%) would appreciate having a guideline or ethical code and 370 (41.2%) of those who have not yet operated on friends and relatives would like to have such an ethical code. CONCLUSION: Most of the surgeons who responded accepted the task of operating on friends or relatives. Performing surgery on friends or relatives was a complex matter because objectivity was not guaranteed. Negative implications on personal relationships were rare. We recommend that this matter should be well considered and discussed with the patient and an ethical guideline or code should be created.

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

OBJECTIVE: For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. METHODS: This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra- and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). RESULTS: Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra- and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). CONCLUSIONS: Although comparable in terms of safety, TVC caused less pain, increased satisfaction with the aesthetic result, and improved postoperative quality of life in the short term.

Transvaginal hybrid-NOTES appendectomy in routine clinical use: prospective analysis of 13 cases and description of the procedure.

BACKGROUND: Access-related abdominal wall injury is part of the operative trauma in laparoscopic appendectomy and accounts for complications. Minimizing this trauma by entering the abdominal cavity by means of natural orifice transluminal surgery (NOTES) may be achieved by a hybrid-appendectomy procedure using the transvaginal route plus a single transumbilical trocar. METHODS: Thirteen patients were prospectively analyzed following transvaginal-hybrid NOTES appendectomy. For the procedure, rigid instruments are used with the patient in lithotomy position. The procedure is performed with two transvaginal and one transumbilical access-points. The specimen is retrieved transvaginally. RESULTS: All procedures were performed without additional trocars. No conversions to standard laparoscopy or open surgery were necessary. All procedures were performed in acceptable time (mean 52 min). No intraoperative complications and two (15%) postoperative complications, an infected hematoma and an abscess, occurred. They were smoothly treated with standard techniques including one laparoscopic reoperation (8%). Drain placement or resection of a Meckel's diverticulum was easily managed without conversion. Gynecological short-term follow-up revealed one complication, which was vaginal fungal infection. It occurred after a 7-day course of antibiotics. CONCLUSION: This method is found to be feasible intraoperatively and early postoperatively in terms of possibility to manage a variety of intraoperative findings that may occur during planned appendectomy, low intraoperative complications, and management of postoperative complications using established concepts. We, therefore, consider the procedure safe and continue to offer hybrid-NOTES appendectomy to suitable patients.

Transvaginal hybrid NOTES cholecystectomy--results of a randomized clinical trial after 6 months.

INTRODUCTION: For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2-3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy. METHODS: To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains "satisfaction" and "pain" of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months. RESULTS: Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P = 0.004 and P < 0.001). There were no postoperative pathological gynecological findings. CONCLUSIONS: Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.

Appendectomy in Germany-an analysis of a nationwide survey 2011/2012.

INTRODUCTION: Although appendectomies are frequently performed and new procedural techniques have emerged, no nationwide analysis exists after the cessation of the German quality control in 2004. METHODS: One thousand eight hundred seventy surgical hospitals in Germany were asked to answer questions anonymously concerning the size of the department, applied procedural techniques, various technical details, as well as the approach to the intraoperative finding of an inconspicuous appendix. RESULTS: We received 643 questionnaires (34.4 %) for evaluation. Almost all hospitals (95.5 %) offer laparoscopic appendectomy (LA), 15.4 % offer single-port (SPA), and 2.2 % (hybrid-) NOTES technique (NA). LA is the standard procedure in 85.2 % of male and in 89.1 % for female patients. In an open procedure (OA), the appendix and mesoappendix are mostly ligated (93.8 and 91.5 %). A Veress needle and open access are employed equally for LA. In 66.6 % of LA, the appendix is divided using an Endo-GIA, the mesoappendix in 45.5 % with bipolar coagulation. Almost half of the hospitals routinely flush the site in OA and LA. In open surgery with an inconspicuous appendix but a pathological finding elsewhere in the abdomen, it is resected "en principe" in 64.7 % and in the absence of any pathological finding in 91.2 %. For laparoscopic procedures, the numbers are 54.8 and 88.4 %. CONCLUSIONS: Most German hospitals perform appendectomies laparoscopically regardless of patients' gender. Usage of an Endo-GIA is widely established. SPA has not gained much acceptance, nor is NA widely used yet. In the absence of any pathological findings in particular, the macroscopically inconspicuous appendix results in an appendectomy "en principe" in most German hospitals.

Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study.

BACKGROUND: Natural orifice surgery (NOS) is gaining acceptance as an alternative to the traditional laparoscopic technique, especially for cholecystectomy through the transvaginal route. However, NOS remains controversial concerning expected advantages in terms of short- and long-term outcomes and potential side effects. This study was designed to compare short-term outcomes between transvaginal/transumbilical and classical laparoscopic cholecystectomy (LC). METHODS: A prospective matched-cohort study compared the authors' first 50 transvaginal/transumbilical cholecystectomies (TVC) with a group of 50 classical LCs from the corresponding period matched in terms of age, body mass index, and American Society of Anesthesiology classification. In both groups, elective surgery was performed for symptomatic cholecystolithiasis. In the NOS group, a hybrid procedure was performed with one transumbilical rigid instrument and two transvaginal rigid instruments. A numeric rating scale was used for daily pain assessment, initiated postoperatively in the recovery room. Both groups were compared with regard to length of surgery, intra- and postoperative complications, length of hospital stay, postoperative pain, and consumption of analgesics. RESULTS: The length of surgery and the rate of complications were similar in the two groups. But significant advantages were found for the transvaginal access in terms of pain using Numeric Rating Scale (NRS) on the day of surgery (NRS, 1.5/10 vs 3.1/10; p = 0.003) as well as 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 1, and with regard to the length of the postoperative hospital stay (2.7 vs 3.4 days; p = 0.035). CONCLUSIONS: The findings show that TVC is a safe procedure for female patients. It has a risk comparable with that of classic LC, causes significantly less pain in the early postoperative period, and leads to a significantly shorter hospital stay. Prospective randomized trials are necessary to confirm these results.

Restorative restproctectomy as single-port surgery through the ostomy site in a three-stage procedure.

PURPOSE: Single-port laparoscopic surgery as an alternative to traditional laparoscopic technique is anticipated to be beneficial in the early postoperative course. We describe restorative restproctectomy as single-port surgery through the ostomy site in a three-stage procedure for refractory ulcerative colitis 12 weeks after laparoscopic subtotal colectomy. SURGICAL TECHNIQUE: After release of the terminal ileostomy, creating the ileal J pouch extra-abdominally, a single-port device was placed. Through this, the rectal stump was mobilized and extracorporeally closed. The ileal pouch anal anastomosis was created using circular double-stapling technique. The single-port device was removed, and the loop ileostomy was placed at the same site. RESULTS: We employed this technique in a 54 year-old patient who had suffered from ulcerative colitis. No postoperative complications were observed. CONCLUSIONS: Restorative restproctectomy as single-port surgery through the ostomy site is safe and feasible. No additional incision is necessary. The trauma of conventional laparoscopic access can be further reduced.

VACStent: Combining the benefits of endoscopic vacuum therapy and covered stents for upper gastrointestinal tract leakage.

Background and study aims Endoscopic treatment has markedly improved the high morbidity and mortality in patients with upper gastrointestinal tract leakage. Most procedures employ either covered self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT), both with good clinical success but also with concomitant significant shortcomings inherent in each technique. A newly developed device, the VACStent, combines the fully covered SEMS with a polyurethane sponge cylinder anchored on the outside. This allows endoluminal EVT while keeping the intestinal lumen patent. The benefit is prevention of stent migration because the suction force of the sponge-cylinder immobilizes the VACStent on the intestinal wall, while at the same time, the attached external vacuum pump suctions off any secretions and improves healing with negative-pressure wound treatment (NPWT). Patients and methods In this pilot study, the first patients to receive the VACStent were assessed. Outcomes included the applicability and stability of the VACStent system together with the clinical course. Results Three patients with different clinical courses were managed with the VACStent. The first patient suffered anastomotic leakage following subtotal esophagectomy and was successfully treated with two postoperative VACStents for 12 days. The second patient received a covered SEMS for 14 days for acute Boerhaave syndrome. Due to persistent leakage, management was converted to EVT. Seven days, later a VACStent was inserted to allow oral nutrition while the leak finally closed. In the third patient, a LINX Reflux Management System had to be removed for erosion, leaving the gastroesophageal junction (GEJ) with a full-thickness gap. After VACstent insertion, successful closure was achieved within 4 days. Conclusions These clinical cases demonstrate the applicability and efficacy of the VACstent in management of esophageal and anastomotic leakage. With its vacuum sponge, the stent fosters wound healing while the covered SEMS keeps the passage patent for nutrition.

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.