A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Laparoscopy compared with laparoscopically guided minilaparotomy for large adnexal masses: a randomized controlled trial. Laparoscopic-assisted abdominoperineal resection for low rectal adenocarcinoma. Ultrasonic versus standard electric dissection in laparoscopic colorectal surgery: a prospective randomized clinical trial. A reevaluation of antibiotic prophylaxis in laparoscopic cholecystectomy: a randomized controlled trial. Laparoscopic versus open total mesorectal excision with anal sphincter preservation for low rectal cancer. Laparoscopic Burch colposuspension: a randomized controlled trial comparing two transperitoneal surgical techniques. Outcome of laparoscopic surgery for rectal cancer in 101 patients.
A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased. Several studies have shown that goal-directed hemodynamic and fluid optimization may result in improved outcome. However, the methods used were either invasive or had other limitations. The aim of this study was to perform intraoperative goal-directed therapy with a minimally invasive, easy to use device (FloTrac/Vigileo), and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a standard management protocol.
                In this randomized, controlled trial 60 high-risk patients scheduled for major abdominal surgery were included. Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol (FloTrac/Vigileo device, GDT-group, n = 30) or a standard management group (Control-group, n = 30), based on standard monitoring data.
                The median duration of hospital stay was significantly reduced in the GDT-group with 15 (12 - 17.75) days versus 19 (14 - 23.5) days (P = 0.006) and fewer patients developed complications than in the Control-group [6 patients (20%) versus 15 patients (50%), P = 0.03]. The total number of complications was reduced in the GDT-group (17 versus 49 complications, P = 0.001).
                In high-risk patients undergoing major abdominal surgery, implementation of an intraoperative goal-directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a standard management protocol.
                Clinical trial registration information: Unique identifier: NCT00549419. To address the efficacy in terms of intraperitoneal spillage of laparoscopically guided minilaparotomy compared with operative laparoscopy for large adnexal cysts.
                A randomized controlled trial was carried out at a tertiary referral center from January 2005 to September 2006. Sixty eligible patients affected by nonendometriotic adnexal cysts with diameter between 7 and 18 cm were randomly assigned to either operative laparoscopy or laparoscopically guided minilaparotomy.
                The relative risk for intraperitoneal spillage among women treated with laparoscopy was 5.55 (95% confidence interval 1.88-16.33). Operative times were significantly shorter in patients who underwent laparoscopically guided minilaparotomy. Surgical difficulty was significantly higher in patients treated with laparoscopy. However, postoperative stay was shorter.
                Laparoscopically guided minilaparotomy, when compared with laparoscopy, is able to reduce intraperitoneal spillage in patients with presumably benign large adnexal masses, with minimal increase in patient short- and long-term discomfort. Because data regarding the importance of intraperitoneal spillage during surgery for benign and malignant pathologies, as well as rupture rates during traditional laparotomy, are scarce, traditional laparotomy still represents the standard treatment. In women desiring a minimally invasive strategy for large cysts, laparoscopically guided minilaparotomy should be considered.
                Australian Clinical Trials Registry, www.actr.org.au, ACTR N012607000241437,
                I. Laparoscopic-assisted resection for colorectal lesions is feasible, but most reported series are heterogeneous and noncomparative. The aim of this study was to investigate whether laparoscopic-assisted resection was better than open abdominoperineal resection for low rectal adenocarcinoma.
                Twenty-five (study group) of 59 consecutive patients who were considered suitable were selected for laparoscopic-assisted abdominoperineal resection based on the availability of informed consent, laparoscopic instruments, and experienced surgeons. The results in these patients were compared with the other 34 patients operated on by the open method (control group).
                The median follow-up times for the study and control groups were 30.1 and 28.3 months, respectively. The operation time was significantly longer (t-test, p < 0.001), while operative blood loss (Mann-Whitney U test, p = 0.02), postoperative analgesic requirement (Mann-Whitney U test, p = 0.02), time to resume normal diet (Mann-Whitney U test, p = 0.04), and total hospital stay (Mann-Whitney U test, p = 0.02) were significantly less in the study than in the control group. The oncological clearance, complication rate, disease-free interval, and survival were comparable in the two groups.
                Laparoscopic-assisted abdominoperineal resection allowed earlier postoperative recovery, with equal oncological clearance, morbidity, mortality, disease-free interval, and survival. To assess the safety and efficacy of the ultrasonic dissection (UC) compared with standard electrosurgery (ES) in laparoscopic colorectal surgery.
                High-frequency ultrasound energy was introduced in laparoscopic surgery to improve dissection and coagulation. Very limited data have been published on its use in laparoscopic colorectal surgery.
                Patients eligible for elective laparoscopic right or left hemicolectomy (RH and LH), sigmoidectomy (SG), or low anterior resection (LAR) were randomized to either UC or ES. The following data were collected and analyzed: preoperative data (individual patient data, indication for surgery), intraoperative data (conversion to open surgery, conversion ES to UC, operative time, blood loss, complication rate), and postoperative data (morbidity and mortality, volume of drainage, hospital stay).
                Between January 2002 and December 2003, 171 patients underwent elective laparoscopic colorectal resection. Twenty-5 patients did not satisfy the inclusion criteria and were excluded. The diagnosis of the remaining 146 patients was diverticulitis (44), colonic adenoma (31), adenocarcinoma (70), or epidermoid carcinoma (1). These patients underwent laparoscopic RH (28), LH (31), SG (47), or LAR (40). There were no differences in preoperative data. The overall conversion rate to open surgery was 11.6%, with no differences between the two groups; 20.8% undergoing ES were converted to UC, more frequently during right hemicolectomy or low anterior resection. Operative time, the primary endpoint of this study, did not differ between the two groups: UC 93 minutes versus ES 102.6 minutes (P = 0.46). Intraoperative blood loss was significantly less in UC 140.8 mL versus ES 182.6 mL (P = 0.032). No differences were observed in postoperative morbidity or other preoperative or postoperative parameters.
                UC is a useful device in laparoscopic colorectal surgery that facilitates completion of difficult cases and reduces intraoperative blood loss. Nevertheless, the majority of laparoscopic procedures can be completed with ES. Therefore, selective use of UC appears to be the most cost-effective policy. To assess the result of antibiotic prophylaxis in low-risk patients undergoing elective laparoscopic cholecystectomy with respect to the postoperative septic complications.
                One hundred and two low-risk patients were randomized into 1 of 2 treatment arms (1) cefazolin 1 g intravenously after induction of anesthesia (PA group) and (2) no prophylactic antibiotics (NONE group). Laparoscopic cholecystectomy was attempted in all cases. The patients were followed-up for postoperative septic complications for at least 30 days at the out-patient clinic or by telephone contact. In both groups, sex, age, weight, American Society of Anesthesiologists patient classification score, operative time, surgical techniques, number of port sites, intraoperative cholangiograms, intraoperative gallbladder rupture, postoperative hospital stay, and postoperative septic complications were compared. The statistical analysis of data performed by computer program SPSS 10.0 for Windows was based on the Independent-Samples T Test or the Pearson Chi-Square (2-sided).
                There was only one minor problem of superficial wound infection in the NONE group. Comparison of data showed no statistically significant difference between the groups.
                Antibiotic Prophylaxis may not be necessary in low-risk patients undergoing elective laparoscopic cholecystectomy. The Laparoscopic approach has been applied to colorectal surgery for many years; however, there are only a few reports on laparoscopic low and ultralow anterior resection with construction of coloanal anastomosis. This study compares open versus laparoscopic low and ultralow anterior resections, assesses the feasibility and efficacy of the laparoscopic approach of total mesorectal excision (TME) with anal sphincter preservation (ASP), and analyzes the short-term results of patients with low rectal cancer.
                We analyzed our experience via a prospective, randomized control trail. From June 2001 to September 2002, 171 patients with low rectal cancer underwent TME with ASP, 82 by the laparoscopic procedure and 89 by the open technique. The lowest margin of tumors was below peritoneal reflection and 1.5-8 cm above the dentate line (1.5-4.9 cm in 104 cases and 5-8 cm in 67 cases). The grouping was randomized.
                Results of operation, postoperative recovery, and short-term oncological follow-up were compared between 82 laparoscopic procedures and 89 controls who underwent open surgery during the same period. In the laparoscopic group, 30 patients in whom low anterior resection was performed had the anastomosis below peritoneal reflection and more than 2 cm above the dentate line, 27 patients in whom ultralow anterior resection was performed had anastomotic height within 2 cm of the dentate line, and 25 patients in whom coloanal anastomosis was performed had the anastomosis at or below the dentate line. In the open group, the numbers were 35, 27, and 27, respectively. There was no statistical difference in operation time, administration of parenteral analgesics, start of food intake, and mortality rate between the two groups. However, blood loss was less, bowel function recovered earlier, and hospitalization time was shorter in the laparoscopic group.
                Totally laparoscopic TME with ASP is feasible, and it is a minimally invasive technique with the benefits of much less blood loss during operation, earlier return of bowel function, and shorter hospitalization. To compare the effectiveness of two transperitoneal laparoscopic Burch procedures.
                The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an alpha = 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies.
                The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P <.05).
                Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique. This study was conducted to investigate the feasibility of laparoscopic resection of rectal cancer and to compare early outcome data with the results of the conventional technique.
                From January 1996 to March 2002, 435 patients with primary rectal cancer were operated on at our institution. Low-risk, small rectal tumors treatable by local excision, rectal cancer recurrences, and emergency cases were excluded from the analysis. Three hundred thirty-four patients were operated on by the conventional open approach. One hundred one selected patients underwent surgery by the laparoscopic technique.
                Because of the selection process, significantly more patients with early tumor stages were operated on by laparoscopy. There were no differences in mean operation time, morbidity, mortality, or the anastomotic leakage rate; however, the need for intraoperative transfusion, mean stay in the intensive care unit, and length of hospital stay were reduced significantly.
                In terms of the intraoperative and early postoperative course, the laparoscopic resection of rectal cancer in a selected cohort of patients compares favorably with the open technique. Because follow-up time is limited to date, only very preliminary information can be given on tumor-related outcome data. However, these preliminary data appear to suggest that rectal cancer resection can be performed by laparoscopy in accordance with established principles of cancer therapy and that port-site metastases are not a relevant clinical problem. Prospective, randomized trials are required to determine whether the laparoscopic approach will play a significant role in the treatment of rectal cancer in the future.
The quantity and especially quality of data are low. Analysis shows a reduction in overall complications, but major complications were not reduced. Length of stay was reduced significantly. We state that ERAS seems safe, but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the standard of care. Within ERAS protocols included, no answer regarding the role for minimally invasive surgery (i.e. laparoscopy) was found. Furthermore, protocol compliance within ERAS programs has not been investigated, while this seems a known problem in the field. Therefore, more specific and large RCT's are needed.