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.

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.

Systematic analysis of the safety and benefits of transvaginal hybrid-NOTES cholecystectomy.

AIM: To evaluate transvaginal hybrid-NOTES cholecystectomy (TVC) during its clinical establishment and compare it with the traditional laparoscopic technique (LC). METHODS: The specific problems and benefits of TVC were reviewed using a registry analysis, a comparative cohort study and a randomized clinical trial. At first, feasibility, safety and specific complications of the TVC were analyzed based on the first 488 data sets of the German NOTES Registry (GNR). Hereafter, we compared the early postoperative results of our first 50 TVC-patients with those of 50 female LC-patients matched by age, BMI and ASA classification. The same cohort was contacted an average of two years later to evaluate long-term results concerning pain and satisfaction with the aesthetic results and the overall postoperative results as well as sexual intercourse by means of two domains of the German version of the Female Sexual Function Index (FSFI-d). Consequently, we performed a randomized clinical trial comparing 20 TVC-patients with 20 needlescopic/3-trocar cholecystectomies (NC) also concerning the early postoperative results as well as pain, satisfaction and quality of life by means of the Eypasch Gastrointestinal Quality of Life Index (GIQLI) in the later course. Finally, we discussed the results in accordance with other published studies. RESULTS: The complication (3.5%) and conversion rates (4.1%) for TVC were low in the GNR and comparable to those of the LC. Access related intraoperative complications included injuries to the bladder (n = 4; 0.8%) and bowel (n = 3; 0.6%). The study cohort revealed less postoperative pain after TVC comparing to the LC-patients on the day of surgery (NRS, 1.5/10 vs 3.1/10, P = 0.003), in the morning (NRS, 1.9/10 vs 2.8/10, P = 0.047) and in the evening (NRS, 1.1/10 vs 1.8/10, P = 0.025) of postoperative day (POD) one. The randomized clinical trial consistently found less cumulative pain until POD 2 (NRS, 8/40 vs 14/40, P = 0.043), as well as until POD 10 (NRS, 22/190 vs 41/190, P = 0.010). Furthermore, the TVC-patients had a better quality of life on POD 10 than did the LC-patients (GIQLI, 124/144 vs 107/144, P = 0.028). The complication rates were comparable and no specific problems were detected in the long-term follow-up for sexual intercourse for either group. The TVC-patients were more satisfied with the aesthetic result in the long-term course in the matched cohort analysis (1.00 vs 1.88, P < 0.001) as well as in the randomized clinical trial (1.00 vs 1.70, P < 0.001) when compared with the LC-patients. CONCLUSION: TVC is a feasible procedure with a high safety profile and has advantages in regard to postoperative pain and aesthetic results when compared with LC or NC.

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 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.

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.

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.

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.

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.

Laparoscopy for a ventriculoperitoneal shunt tube dislocated into the colon.

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

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.