Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study.

PURPOSE: Anastomotic leak (AL) represents the most relevant and devastating complication in colorectal surgery. Endoscopic vacuum therapy (EVT) using the VACStent is regarded as a significant improvement in the treatment of upper gastrointestinal wall defects. The innovative concept of the VACStent was transferred to the lower GI tract, gaining initial experience by investigating safety and efficacy in 12 patients undergoing colorectal resections. METHODS: The pilot study, as part of a German registry, began with 2 patients suffering from AL, who were treated with the VACStent after stoma placement. Subsequently, 6 patients with AL were treated with the VACStent omitting a stoma placement, with a focus on fecal passage and wound healing. Finally, the preemptive anastomotic coverage was investigated in 4 patients with high-risk anastomoses to avoid prophylactic stoma placement. RESULTS: In total 26 VACStents were placed without problems. The conditioning and drainage function were maintained, and no clogging problems of the sponge cylinder were observed. No relevant clinical VACStent-associated complications were observed; however, in 2 patients, a dislodgement of a VACStent occurred. The 6 patients with AL but without stoma had a median treatment with 3 VACStents per case with a laytime of 17 days, leading to complete wound healing in all cases. The 4 prophylactic VACStent applications were without complications. CONCLUSION: The clinical application of the VACStent in the lower GI tract shows that successful treatment of anastomotic colonic leaks and avoidance of creation of an anus praeter is possible. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04884334, date of registration 2021-05-04, retrospectively registered.

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.

Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

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.

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.

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.

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.

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.

VacStent as an Innovative Approach in the Treatment of Anastomotic Insufficiencies and Leakages in the Gastrointestinal Tract-Review and Outlook.

Anastomotic insufficiencies are severe complications of abdominal surgery, often leading to prolonged hospitalization, serious tissue inflammation, and even sepsis, along with the need for recurrent surgery. Current non-surgical treatments such as self-expanding metal stents (SEMSs) and endoscopic vacuum therapy (EVT) have limitations, including stent migration or perforation. This review evaluates the effectiveness of the VacStent GITM (Möller Medical GmbH, Fulda, Germany), a novel medical device combining SEMS and negative-pressure wound therapy in treating gastrointestinal leaks. Data were gathered from four prospective studies and compared with existing treatments. Studies on the VacStent GITM application demonstrate technical success and competitive closure rates in upper gastrointestinal leaks, with minimal complications reported. Comparative analyses with SEMS and EVT reveal promising and most importantly equally good outcomes while maintaining the possibility for sustained enteral nutrition and reducing the risk of stent migration. The VacStent GITM presents a promising alternative to current non-surgical treatments. Ongoing research aims to validate its efficacy in lower gastrointestinal leaks and comprehensively establish its role in leak management. Further investigation is necessary to confirm these findings and optimize treatment protocols. Future usages of the VacStent GITM in colonic anastomotic insufficiencies promise an effective approach and might be able to lower the rates of necessary implementations of a stoma.

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.

Multimedia-based training on Internet platforms improves surgical performance: a randomized controlled trial.

BACKGROUND: Surgical procedures are complex motion sequences that require a high level of preparation, training, and concentration. In recent years, Internet platforms providing surgical content have been established. Used as a surgical training method, the effect of multimedia-based training on practical surgical skills has not yet been evaluated. This study aimed to evaluate the effect of multimedia-based training on surgical performance. METHODS: A 2 × 2 factorial, randomized controlled trial with a pre- and posttest design was used to test the effect of multimedia-based training in addition to or without practical training on 70 participants in four groups defined by the intervention used: multimedia-based training, practical training, and combination training (multimedia-based training + practical training) or no training (control group). The pre- and posttest consisted of a laparoscopic cholecystectomy in a Pelvi-Trainer and was video recorded, encoded, and saved on DVDs. These were evaluated by blinded raters using a modified objective structured assessment of technical skills (OSATS). The main evaluation criterion was the difference in OSATS score between the pre- and posttest (ΔOSATS) results in terms of a task-specific checklist (procedural steps scored as correct or incorrect). RESULTS: The groups were homogeneous in terms of demographic parameters, surgical experience, and pretest OSATS scores. The ΔOSATS results were highest in the multimedia-based training group (4.7 ± 3.3; p < 0.001). The practical training group achieved 2.5 ± 4.3 (p = 0.028), whereas the combination training group achieved 4.6 ± 3.5 (p < 0.001), and the control group achieved 0.8 ± 2.9 (p = 0.294). CONCLUSION: Multimedia-based training improved surgical performance significantly and thus could be considered a reasonable tool for inclusion in surgical curricula.

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.

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.

Preemptive endoluminal vacuum therapy with the VACStent-A pilot study to reduce anastomotic leakage after Ivor Lewis hybrid esophagectomy.

Introduction: Endoscopic treatment by vacuum therapy (EVT) or covered stents has emerged as an improved treatment option for upper gastrointestinal wall defects and is regarded as an improved treatment option for anastomotic leakage (AL) after esophagectomy. However, endoluminal EVT devices may lead to obstruction of the GI tract; and a high rate of migration and missing functional drainage has been shown for covered stents. The recently developed VACStent, a combination of a fully covered stent within a polyurethane sponge cylinder may overcome these issues allowing EVT while stent passage is still open. Initial clinical applications have demonstrated efficacy, practicability and safety in the treatment of esophageal leaks (AL). Methods: In this pilot study, 9 patients with high-risk anastomosis after neoadjuvant therapy undergoing hybrid esophagectomy received the VACStent in a preemptive setting for the assessment of the reduction of the AL rate, postoperative morbidity and mortality. Results: Technical success of the application of the VACStent® was achieved in all interventions. One patient experienced anastomotic leakage 10 days after esophagectomy and was successfully treated with two consecutive VACStents and a VAC Sponge. In summary, mortality in-hospital was 0% and anastomotic healing was uneventful without septic episodes. No severe device-related adverse events (SADE) nor significant local bleeding or erosion could be observed. Oral intake of liquids or food was documented in all patients. The device handling was regarded uncomplicated. Discussion: The preemptive application of the VACStent offers a promising new option for improved clinical treatment avoiding of critical situations in hybrid esophagectomy, which should be validated in a large clinical study.

Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.

BACKGROUND: The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. METHODS: This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. FINDINGS: Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53­1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. INTERPRETATION: Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. FUNDING: German Federal Ministry of Education and Research.