Feasibility and effectiveness of laparoscopic transgastric stapler-assisted circumferential esophageal mucosectomy and simultaneous fundoplication in a pig model.

Laparoscopic transgastric stapler-assisted mucosectomy (SAM) has been described for minimally invasive circumferential en bloc resection of Barrett's esophagus (BE). Conceivably long-term disease control might be achieved by adding antireflux surgery after resection of BE by SAM. The aim of this study was to assess the feasibility of combined SAM and fundoplication in one laparoscopic procedure in six pigs. Furthermore, the competence of the gastroesophageal junction (GEJ) was assessed at baseline, after SAM, and after subsequent laparoscopic fundoplication. At each measuring point reflux measurements were repeated 6 times in each pig. Blue-colored water was infused into the stomach to provoke reflux. Intragastric yield pressure and volume were recorded until drainage of blue solution (DBS) was noted. Time to reflux was measured by DBS and by multichannel intraluminal impedance (MII). In all animals SAM followed by laparoscopic fundoplication was feasible in a single session. A weakening of the GEJ was found after SAM, indicated by decreased yield pressure (11.5 mmHg vs. 8.5 mmHg; P < 0.001), time to DBS (90 seconds vs. 60 seconds; P = 0.008) and MII (80 seconds vs. 33 seconds; P < 0.001). After additional Nissen fundoplication the GEJ competence was restored, with measurements returning to baseline values (time to DBS 99 seconds; P = 0.15; MII 76 seconds; P = 0.84). The yield pressure increased from 11.5 mmHg at baseline to 19.7 mmHg after SAM and fundoplication (P < 0.001). Laparoscopic fundoplication and SAM may be combined in a single laparoscopic session. Although the GEJ was weakened after SAM, Nissen fundoplication restored the GEJ as an effective reflux barrier in this experiment. For clinical validation, the results need to be confirmed in a prospective human trial.

Meta-analysis of hybrid natural-orifice transluminal endoscopic surgery versus laparoscopic surgery.

BACKGROUND: Hybrid natural-orifice transluminal endoscopic surgery (NOTES), combining access through a natural orifice with small-sized abdominal trocars, aims to reduce pain and enhance recovery. The objective of this systematic review and meta-analysis was to compare pain and morbidity in hybrid NOTES and standard laparoscopy. METHODS: A systematic literature search was performed to identify RCTs and non-RCTs comparing hybrid NOTES and standard laparoscopy. The main outcome was pain on postoperative day (POD) 1. Secondary outcomes were pain during the further postsurgical course, rescue analgesia, complications, and satisfaction with the cosmetic result. The results of meta-analysis in a random-effects model were presented as odds ratio (ORs) or standard mean differences (MDs) with 95 per cent confidence intervals. RESULTS: Six RCTs and 21 non-randomized trials including 2186 patients were identified. In hybrid NOTES the score on the numerical pain scale was lower on POD 1 (-0·75, 95 per cent c.i. -1·09 to -0·42; P = 0·001) and on POD 2-4 (-0·58, -0·91 to -0·26; P < 0·001) than that for standard laparoscopy. The need for rescue analgesia was reduced in hybrid NOTES (OR 0·36, 0·24 to 0·54; P < 0·001). The reduction in complications found for hybrid NOTES compared with standard laparoscopy (OR 0·52, 0·38 to 0·71; P < 0·001) was not significant when only RCTs were considered (OR 0·83, 0·43 to 1·60; P = 0·570). The score for cosmetic satisfaction was higher after NOTES (MD 1·14, 0·57 to 1·71; P < 0·001). CONCLUSION: Hybrid NOTES reduces postoperative pain and is associated with greater cosmetic satisfaction in selected patients.

[Laparoscopic versus open rectal cancer resection: oncologically equal?]. / Laparoskopische vs. offene Rektumresektion: onkologisch gleichwertig?

The oncological equivalence of laparoscopic and open rectal cancer resection was evaluated in four multicenter randomized controlled trials. The COLOR II and the COREAN trials demonstrated oncological equivalence; however, the ACOSOG and the ALaCaRT studies came to a different conclusion. In the latter two studies a composite endpoint that assessed the quality of the mesorectal specimen, the completeness of tumor-free circumferential and distal resection margins was chosen. In both trials a higher success rate for open surgery was shown; nevertheless, the validity of this composite endpoint has not been proven and no conclusions on solid oncological endpoints can be drawn. The COLOR II and the COREAN trial therefore remain the only available studies which investigated solid oncological endpoints, such as local recurrence and disease-free survival over an adequate follow-up time period of 3 years; however, the comparability of the study groups at least of the COLOR II trial needs to be called into question as only the experience of the laparoscopic surgeons was assessed. With a local recurrence rate of 5 % in both groups the oncological quality seems nevertheless to be good; therefore, a systematically inadequate control group should not be assumed. At this point it can be concluded that a good oncological outcome can be achieved with laparoscopic rectal resection in the hands of experts. For a final assessment the long-term results of the on-going trials needs to be awaited. If the promising results for laparoscopic surgery of the COLOR II trial are confirmed laparoscopic rectal resection should be preferred to open resection in the future. This conclusion is based on the generally known perioperative benefits of minimally invasive surgery.

Transvaginal access for NOTES: a cohort study of microbiological colonization and contamination.

BACKGROUND AND STUDY AIMS: Animal data and limited clinical evidence suggest a low incidence of infection following transvaginal natural orifice transluminal endoscopic surgery (NOTES). However, a systematic microbiological evaluation has not yet been carried out. The aim of this prospective cohort study was to evaluate the extent of microbiological contamination of the peritoneal cavity caused by the transvaginal access for NOTES and the impact of preoperative vaginal disinfection on vaginal colonization. PATIENTS AND METHODS: Consecutive female patients with symptomatic cholecystolithiasis were offered either transvaginal rigid-hybrid cholecystectomy (tvCCE) or conventional laparoscopic cholecystectomy. Patients who opted for tvCCE were prospectively evaluated between February and June 2010. Disinfection in patients undergoing tvCCE included hexetidine tablets and octenidine applied vaginally. All patients received a single dose of perioperative cefuroxime. Swabs were obtained from the posterior fornix and the peritoneal cavity at different intervals. RESULTS: Of 32 patients, 27 (84 %) opted to undergo tvCCE. One patient (4 %; 95 % confidence interval [CI] 0.7 % - 18.3 %) had a positive bacterial culture in the Douglas pouch prior to transvaginal access compared with two patients (7 %; 95 %CI 2.1 % - 23.4 %) following colpotomy closure (P = 1.000). Vaginal disinfection significantly decreased vaginal bacterial load (P = 0.001) and bacterial growth in routine cultures (P < 0.001); in 16 patients (59 %; 95 %CI 40.7 % - 75.5 %) vaginal swabs were sterile after disinfection. No postoperative surgical site infections occurred (95 %CI 0 % - 12.5 %). CONCLUSIONS: In selected patients and following vaginal antisepsis, transvaginal access for NOTES is associated with microbiological contamination of the peritoneal cavity in a minority of patients, indicating a low risk of peritoneal contamination caused by the transvaginal access.

Transvaginal rigid-hybrid NOTES cholecystectomy: evaluation in routine clinical practice.

BACKGROUND AND STUDY AIMS: Cholecystectomy using a rigid-hybrid transvaginal natural orifice transluminal endoscopic surgery (NOTES) approach (tvNCC) reduces abdominal wall incisions and might decrease surgical trauma by combining endoluminal access and laparoscopic techniques. We assessed the feasibility and safety of rigid-hybrid tvNCC in routine practice for symptomatic cholecystolithiasis or acute cholecystitis in a patient population with low selection. PATIENTS AND METHODS: From September 2008 to July 2009, all female patients with cholecystectomy indications were evaluated for tvNCC. Exclusion criteria were: refusal of tvNCC; inability to give informed consent; gynecological or urological contraindications; lack of preoperative gynecological examinations; need for cholangiography/choledochus revision; anesthesiological contraindications to pneumoperitoneum; liver failure; or coagulopathy. Age, obesity, previous surgery, or degree of gallbladder inflammation were not exclusion criteria. Preoperative and 2-weeks' postoperative gynecological examinations were performed. Sexual function was assessed preoperatively and at 6 weeks postoperatively. RESULTS: 102 of 137 consecutive patients (74.5 %) with symptomatic cholecystolithiasis (n = 74) or cholecystitis (n = 28) were scheduled for rigid-hybrid tvNCC with nine different surgeons. Patient mean age was 52.3 +/- 17.8 years (range 18 - 87) and mean body mass index 27.3 +/- 6.3 kg/m (2) (17.6 - 43.8). Two patients had conversion to conventional laparoscopic cholecystectomy. There were no intraoperative complications. Two major complications occurred: one stroke and one herniation within the transumbilical access. Minor complications were reported in 13 patients (12.7 %) and there were no serious postoperative gynecological findings. At 6 weeks postoperatively, there were fewer dyspareunia symptoms than preoperatively ( P = 0.049). CONCLUSIONS: Rigid-hybrid tvNCC is feasible and safe in routine practice for symptomatic cholecystolithiasis and acute cholecystitis.