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).

Long-term oncologic outcomes following anastomotic leak after anterior resection for rectal cancer: does the leak severity matter?

BACKGROUND: The evidence regarding the impact of anastomotic leak (AL) after anterior resection (AR) for rectal cancer on oncologic outcomes is controversial, and there are no data about the prognostic relevance of the International Study Group of Rectal Cancer (ISREC) AL classification. The aim was to evaluate the oncologic outcomes in patients with AL after AR for rectal cancer. The prognostic value of the ISREC AL grading system was also investigated. METHODS: It is a retrospective analysis of a prospectively collected database including all patients undergoing curative elective AR for rectal cancer (April 1998-September 2013). AL severity was defined according to the ISREC criteria. A multivariable analysis was performed to identify predictors of poor survival. RESULTS: A total of 532 patients underwent curative AR (69% laparoscopic) for rectal cancer. The overall AL rate was 7.9%: 15 grade B and 27 grade C ALs. With a median follow-up of 80 (range 12-266) months, 5-year overall survival (OS) was 67.2% in patients with AL and 86.5% in those without AL (P = 0.001). Five-year disease-free survival (DFS) was 50.5% and 80.3%, respectively (P < 0.001). Local recurrence and distant metastases developed more frequently in AL patients (P < 0.05). Grade B AL and no administration or delay of adjuvant chemotherapy were independent predictors for poorer OS and DFS. Grade B AL independently affected also the administration of adjuvant chemotherapy. Circulating C-reactive protein levels at 2 weeks after AL treatment were higher in grade B than grade C patients (P = 0.006) and in patients with tumor relapse (P = 0.011). CONCLUSION: AL after curative AR for rectal cancer and impaired use of adjuvant chemotherapy are associated with poor survival. Postoperative systemic inflammation seems to be more sustained in grade B than that in grade C AL patients, with possible adverse impact on long-term survival.

Laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct.

BACKGROUND: The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. OBJECTIVES: To compare the benefits and harms of endoscopic sphincterotomy and stone removal followed by laparoscopic cholecystectomy (the single-stage rendezvous technique) versus preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy (two stages) in people with gallbladder and common bile duct stones. SEARCH METHODS: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded Web of Science, and two trials registers (February 2017). SELECTION CRITERIA: We included randomised clinical trials that enrolled people with concomitant gallbladder and common bile duct stones, regardless of clinical status or diagnostic work-up, and compared laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy procedures in people undergoing laparoscopic cholecystectomy. We excluded other endoscopic or surgical methods of intraoperative clearance of the bile duct, e.g. non-aided intraoperative endoscopic retrograde cholangiopancreatography or laparoscopic choledocholithotomy (surgical incision of the common bile duct for removal of bile duct stones). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. MAIN RESULTS: We included five randomised clinical trials with 517 participants (257 underwent a laparoscopic-endoscopic rendezvous technique versus 260 underwent a sequential approach), which fulfilled our inclusion criteria and provided data for analysis. Trial participants were scheduled for laparoscopic cholecystectomy because of suspected cholecysto-choledocholithiasis. Male/female ratio was 0.7; age of men and women ranged from 21 years to 87 years. The run-in and follow-up periods of the trials ranged from 32 months to 84 months. Overall, the five trials were judged at high risk of bias. Athough all trials measured mortality, there was just one death reported in one trial, in the laparoscopic-endoscopic rendezvous group (low-quality evidence). The overall morbidity (surgical morbidity plus general morbidity) may be lower with laparoscopic rendezvous (RR 0.59, 95% CI 0.29 to 1.20; participants = 434, trials = 4; I² = 28%; low-quality evidence); the effect was a little more certain when a fixed-effect model was used (RR 0.56, 95% CI 0.32 to 0.99). There was insufficient evidence to determine the effects of the two approaches on the failure of primary clearance of the bile duct (RR 0.55, 95% CI 0.22 to 1.38; participants = 517; trials = 5; I² = 58%; very low-quality evidence). The effects of either approach on clinical post-operative pancreatitis were unclear (RR 0.29, 95% CI 0.07 to 1.12; participants = 517, trials = 5; I² = 24%; low-quality evidence). Hospital stay appeared to be lower in the laparoscopic-endoscopic rendezvous group by about three days (95% CI 3.51 to 2.50 days shorter; 515 participants in five trials; low-quality evidence). There was very low-quality evidence that suggested longer operative time with laparoscopic-endoscopic rendezvous (MD 34.07 minutes, 95% CI 11.41 to 56.74; participants = 313; trials = 3; I² = 93%). The Trial Sequential Analyses of operating time and the length of hospital stay indicated that all the trials crossed the conventional boundaries, suggesting that the sample sizes were adequate, with a low risk of random error. AUTHORS' CONCLUSIONS: There was insufficient evidence to determine the effects of the laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy techniques in people undergoing laparoscopic cholecystectomy on mortality and morbidity. The laparoscopic-endoscopic rendezvous procedure may lead to longer operating times, but it may reduce the length of the hospital stay when compared with preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy. However, no firm conclusions could be drawn because the quality of evidence was low or very low. If confirmed by future trials, these data might re-design the scenario of treatment of this condition, albeit requiring greater organisational effort. Future trials should also address issues such as quality of life and cost analysis.

Robot-assisted Heller myotomy for achalasia: technique and results.

Since its first description in 1991, laparoscopic Heller myotomy has been associated with better short-term outcomes and shorter recovery time, compared to open operation and it is now generally accepted as the procedure of choice for achalasia. Despite the well-known short-term benefits of laparoscopy, esophageal perforation still occurs. Robotic technology has recently been introduced into laparoscopic clinical practice with the aim of improving surgical performance and excellent results have been described with robotically assisted Heller myotomy in patients with achalasia. The 3-D visualization, the very steady operative view and, above all, the articulated arms of the da Vinci Robotic Surgical System allow the surgeon to visualize and divide each individual muscular fiber, easily identifying the submucosal plane at the GE junction. However, no high-quality studies are available in literature. Moreover, from an economic point of view, the use of the robotic technology may increase both the costs and the volume of surgeries performed.

Is single-incision laparoscopic cholecystectomy safe? Results of a systematic review and meta-analysis.

BACKGROUND: Single-incision laparoscopic cholecystectomy (SILC) is gaining popularity. It is not evident whether the benefits of this procedure overcome the potential increased risk. We performed a systematic review and meta-analysis to compare SILC with conventional multi-incision laparoscopic cholecystectomy (MILC). METHODS: Data from randomized, controlled trials published up to December 2011 and comparing SILC versus MILC were extracted. The primary end point was overall morbidity. A fixed-effect model was applied to summarize the study outcomes in the meta-analysis, and a random-effect model was used in the sensitivity analysis. The outcome measures were relative risk (RR) and mean difference (MD); a RR of <1.0 or a negative MD indicated a more favorable outcome after SILC. Publication bias was assessed by a funnel plot, and heterogeneity was tested by the I (2) measure and subgroup analyses. RESULTS: A total of 12 trials (996 patients) were included. Mortality was nil in both treatment groups; the overall RR for morbidity was 1.36 (p = 0.098). The mean operating time was 47.2 min for MILC and 58.1 min for SILC (MD 9.47 min; p < 0.001). The visual analog scale pain score at 24 h after surgery was 2.96 in MILC and 2.34 in SILC (MD -0.64; p = 0.058), but sensitivity analysis of the four studies deemed at low risk of bias for pain assessment, according to blinding and postoperative analgesic protocols, showed significance at -0.43 points (95 % confidence interval -0.87 to 0.00; p = 0.049). Cosmetic outcome scored better in the SILC group, with its standardized MD being equal to 1.16 (95 % confidence interval 0.57 to 1.75; p < 0.001). CONCLUSIONS: In selected patients, SILC has similar overall morbidity compared with MILC; further, it results in better cosmetic satisfaction and reduced postoperative pain despite longer operative time.

Does peritoneal perforation affect short- and long-term outcomes after transanal endoscopic microsurgery?

BACKGROUND: Peritoneal perforation (PP) is frequently reported as a complication of transanal endoscopic microsurgery (TEM). Nevertheless, these concerns have only rarely been addressed in the literature, with no mention of the long-term oncologic consequences of PP. METHODS: A prospective database was analyzed with the intent to evaluate the influence of PP on the short- and long-term outcomes for patients undergoing TEM. RESULTS: Peritoneal perforation occurred in 28 (5.8%) of 481 patients who underwent TEM for a rectal neoplasm. The conversion rate to abdominal surgery was 10.7% (3/28). All the conversions occurred during the first 100 TEM procedures (3/100 vs 0/381; p = 0.007). The postoperative morbidity rate was 3.6% (1/28), and the 30-day mortality was nil. Compared with the group of patients who had no peritoneal perforation, the PP group showed a significantly longer operating time (120 vs 60 min; p < 0.001) and a significantly longer hospital stay (6 vs 4 days; p = 0.003). Nevertheless, the global morbidity rate and the type of complications according to Dindo's classification were similar. In the multivariate analysis, the only independent predictor of PP was tumor distance from the anal verge (p = 0.010). During a median follow-up period of 48 months (range, 12-150 months), no liver or peritoneal metastases were detected in 13 patients with rectal cancer. CONCLUSIONS: Peritoneal perforation does not seem to affect short-term or oncologic outcomes for patients submitted to TEM with full-thickness resection for upper rectum neoplasms. The use of TEM to resect rectal lesions involving the intraperitoneal rectum may therefore represent an intermediate step toward the development of transrectal natural orifice translumenal endoscopic surgery (NOTES) techniques.

Laparoendoscopic rendezvous reduces perioperative morbidity and risk of pancreatitis.

BACKGROUND: The ideal management of cholelithiasis and common bile duct stones still is controversial. Although the two-stage sequential approach remains the prevalent management, several trials have concluded that the so-called laparoendoscopic rendezvous (LERV) technique offers some advantages, such as a reduced risk of post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis. This study aimed to compare the single-stage LERV technique with the two-stage endoscopic sphincterotomy followed by laparoscopic cholecystectomy. METHODS: A search for randomized controlled trials (RCTs) comparing LERV and the two-stage sequential approach was conducted. The outcomes considered were overall complications and pancreatitis. Medline, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1998 to July 2012. Odds ratios (ORs) were extracted and pooled using a fixed or random-effect model depending on I (2) used as a heterogeneity measure. RESULTS: Four RCTs, including a total of 430 patients, met the inclusion criteria. The incidence of overall complications was lower in the LERV group (11.2 %) than in the two-stage intervention group (18.1 %) (OR, 0.56; 95 % confidence interval [CI], 0.32-0.99; P = 0.04; I (2) = 45 %). The findings showed that LERV was associated with less clinical pancreatitis (2.4 %) than the two-stage technique (8.4 %) (OR, 0.33; 95 % CI, 0.12-0.91; P = 0.03; I (2) = 33 %). CONCLUSIONS: Despite the limitation of a small number of studies completed, the evidence of RCTs shows that LERV is superior to two-stage treatment due to a reduction in overall complications, particularly pancreatitis.

Recurrence after transanal endoscopic microsurgery for large rectal adenomas.

BACKGROUND: Transanal endoscopic microsurgery (TEM) has revolutionized the technique and outcome of transanal surgery, becoming the standard of treatment for large sessile rectal adenomas. Nevertheless, only a few studies have evaluated the risk factors for local recurrence in order to recommend a "tailored" approach. The aim of this study was to identify predictor variables for recurrence after TEM to treat rectal adenoma. METHODS: This study is a retrospective analysis of a prospective database of patients treated for large sessile rectal adenomas by TEM at our institution, with a minimum follow-up of 12 months. Age, gender, tumor diameter, distance from the anal verge, degree of dysplasia, histology, and margin involvement were investigated. RESULTS: Between January 1993 and July 2010, 293 patients with a rectal adenoma ≥3 cm underwent TEM. Postoperative morbidity rate was 7.2 % (21/293) and there was no 30-day mortality. Over a median follow-up period of 110 (range = 12-216) months, 13 patients (5.6 %) were diagnosed with local recurrence. The median time to recurrence was 10 (range = 4-33) months, with 76.9 % of recurrences detected within 12 months after TEM. At univariate analysis, tumor diameter (p = 0.007), and positive margins (p < 0.001) were shown to be significant risk factors, while multivariate analysis indicated the presence of positive margins as the only independent predictor of recurrence (p = 0.003). CONCLUSIONS: TEM provides excellent oncological outcomes in the treatment of large sessile benign rectal lesions, assuring a minimal risk of resection margin infiltration at pathology examination, which represents the only risk factor for recurrence.

10-year follow-up of laparoscopic vertical banded gastroplasty: good results in selected patients.

OBJECTIVE: To evaluate the long-term results of laparoscopic vertical banded gastroplasty (VBG) for morbid obesity. BACKGROUND: Laparoscopic VBG, a safe and straightforward bariatric procedure characterized by good short-term results, has been progressively replaced by other more complex procedures on the basis of a presumed high rate of long-term failure. Nevertheless, some authors have recently reported long-term efficacy in selected patients. METHODS: All patients who underwent laparoscopic VBG were included in a prospective database. Patients reaching 10-year follow-up received a complete evaluation including clinical, endoscopic, and biochemical examinations. RESULTS: Between January 1996 and March 1999, 266 morbidly obese patients underwent bariatric procedures. Among them, 213 were selected for laparoscopic VBG; exclusion criteria were as follows: contraindications to pneumoperitoneum, gastroesophageal reflux disease, and psychological contraindications to restrictive procedures. Mean age, preoperative weight, and body mass index were 36.9 years, 123.6 kg, and 45.4 kg/m, respectively. Intraoperative complication rate and conversion rate were 0.9% and 0.9%, respectively. Early postoperative complication rate was 4.2% and early reoperation rate was 0.5%. Mean hospital length of stay was 6.3 days. Mortality was nil. The 10-year follow-up rate was 70.4% (150 patients). Late postoperative complication rate was 14.7%, and 10-year revisional surgery rate was 10.0%. The excess weight loss percentages at 3, 5, and 10 years were 65.0%, 59.9%, and 59.8%, respectively. The resolution and/or improvement rate for comorbidity were 47.5% for hypertension, 55.6% for diabetes, 75% for sleep apnea, and 47.4% for arthritis. Mean Moorehead-Ardelt Quality of Life Questionnaire and BAROS values were 1.4 and 3.8, respectively. CONCLUSIONS: The present study demonstrates that laparoscopic VBG in carefully selected patients leads to long-term results comparable with more complex and invasive procedures. Given the low postoperative morbidity for laparoscopic VBG, its present clinical role should be, in our opinion, reevaluated.

Simultaneous laparoscopic anterior resection and left hepatic lobectomy for stage IV rectal cancer.

We report the case of a 68-year-old female patient affected by rectal cancer and a synchronous metastatic lesion measuring 8 cm in diameter in the left hepatic lobe. After a laparoscopic ultrasonography exploration of the liver to detect possible occult metastases, a simultaneous colorectal resection and a left hepatic lobectomy including a partial resection of segment IV were performed. Five ports were used for the entire procedure. The resected specimens were extracted through a Pfannenstiel incision. The procedure was completed laparoscopically. Total operative time was 455 minutes with negligible intraoperative blood loss. The postoperative hospital stay was 12 days. At 4-month follow-up, the patient recovered completely. A computed tomography scan performed at this time showed no signs of recurrent disease. This report confirms the feasibility of the laparoscopic approach to simultaneous hepatic and colorectal resections in stage IV rectal cancer. The known advantages of the miniinvasive approach could make such complex procedures more endurable.

Combined anterior and posterior open treatment in infected pancreatic necrosis.

OBJECTIVE: To compare the results of combined anterior and posterior open treatments (lesser sac marsupialization (LSM) + lumbostomy, LSM + L) in patients with infected pancreatic necrosis (IPN) with a previous experience of isolated LSM and with data in literature. MATERIALS AND METHODS: Thirty-four consecutive patients operated on for IPN from 1981 to 2005 were divided into two groups based on the surgical technique used: single LSM (n = 23; period A, 1981-1998) and combined LSM + L (n = 11; period B, 1999-2005). RESULTS: The postoperative mortality rate was 38.1 (n = 8) and 9% (n = 1) during period A and B, respectively. The most important cause of death was recurrent or persistent sepsis with multiple organ failure. The overall postoperative surgical morbidity was 57 (n = 13) and 27.2% (n = 3) in the two consecutive groups. CONCLUSIONS: IPN is a challenging condition associated with high mortality mainly because of a persistence of sepsis despite surgery. A comparative analysis of many proposed operative procedures is difficult because of the heterogeneity in the reported series. Open approaches seem to be more effective in controlling local infection and systemic sepsis. Combining open anterior and posterior approaches is in our experience an appropriate surgical treatment in IPN patients.