Randomised study of influence of two-dimensional versus three-dimensional imaging on performance of laparoscopic cholecystectomy. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Laparoscopic and laparotomic cholecystectomy: a randomized trial comparing postoperative respiratory function. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study. Blind versus open approach to laparoscopic cholecystectomy: a randomized study. Advantages of mini-laparoscopic vs conventional laparoscopic cholecystectomy: results of a prospective randomized trial. Determinants of postoperative infection after laparoscopic cholecystectomy. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study.
Several three-dimensional video-endoscopic systems have been introduced to enhance depth perception during minimum-access surgery. However, there is no conclusive evidence of benefit, and these systems are more expensive than conventional two-dimensional systems. We undertook a prospective randomised comparison of two-dimensional and three-dimensional imaging in elective laparoscopic cholecystectomy for symptomatic gallstone disease.
                The operations were done by four specialist registrars as part of their higher surgical training. 60 operations were randomised for execution by either two-dimensional or three-dimensional imaging display (30 by each method). The degree of difficulty of the operation was graded by a consultant surgeon on a standard grading system. The primary endpoints were execution time and the errors made during the procedure. The secondary endpoints were subjective assessment of the image quality and adverse effects on the surgeon.
                There was no difference between the two-dimensional and three-dimensional display groups in median execution time (3160 [IQR 2735-4335 vs 3100 [2379-3710] s; p = 0.2) or error rate (six vs six). Surgeons reported adverse symptoms immediately after the operations with both systems. The scores for visual strain, headache, and facial discomfort were higher with the three-dimensional system.
                With the current technology, three-dimensional systems based on sequential imaging show no advantage over two-dimensional systems in the conduct of laparoscopic cholecystectomy. The attempt to further reduce operative trauma in laparoscopic cholecystectomy has led to new techniques such as natural orifice transluminal endoscopic surgery (NOTES) and single-incision laparoscopic surgery (SILS). These new techniques are considered to be painless procedures, but no published studies investigate the possibility of different pain scores in these new techniques versus classic laparoscopic cholecystectomy. In this randomized control study, we investigated pain scores in SILS cholecystectomy versus classic laparoscopic cholecystectomy.
                Forty patients (34 women and 6 men) were randomly assigned to two groups. In group A (n = 20) four-port classic laparoscopic cholecystectomy was performed. Patients in group B (n = 20) underwent SILS cholecystectomy. In all patients, preincisional local infiltration of ropivacaine around the trocar wounds was performed. Infusion of ropivacaine solution in the right subdiaphragmatic area at the beginning of the procedure plus normal saline infusion in the same area at the end of the procedure was performed in all patients as well. Shoulder tip and abdominal pain were registered at 2, 6, 12, 24, 48, and 72 h postoperatively using visual analog scale (VAS).
                Significantly lower pain scores were observed in the SILS group versus the classic laparoscopic cholecystectomy group after the first 12 h for abdominal pain, and after the first 6 h for shoulder pain. Total pain after the first 24 h was nonexistent in the SILS group. Also, requests for analgesics were significantly less in the SILS group, while no difference was observed in incidence of nausea and vomiting between the two groups.
                SILS cholecystectomy, as well as the invisible scar, has significantly lower abdominal and shoulder pain scores, especially after the first 24 h postoperatively, when this pain is nonexistent. (Registration Clinical Trial number: NTC00872287, www.clinicaltrials.gov ). The fact that pulmonary complications occur in 20-60% of the patients subjected to abdominal operations clearly indicates that the lungs are the most endangered organ during the postoperative period.
                The aim of this study was to demonstrate the impact of cholecystectomy on postoperative respiratory disturbances by comparing the laparotomic cholecystectomy with laparoscopic gallbladder removal.
                A hundred cholecystectomized patients were included in the prospective randomized clinical trial. Half of the patients were operated on by the laparotomic procedure, whereas the other half underwent laparoscopic cholecystectomy. Spirometric parameters, arterial blood gases, and acid-base balance were determined before the operation, and at 6, 24, 72 and 144 h postoperatively. Abdominal distension was assessed by auscultating intestinal peristaltics, abdominal circumference measurement, and time interval to restitution of defecation.
                Six hours postoperatively, the values of ventilation parameters decreased on average by 40-50% from the baseline preoperative values in both groups of patients. The group of patients submitted to laparotomic cholecystectomy had significantly lower spirometric values and slower recovery of the ventilation parameters than the laparoscopic cholecystectomy group. Abdominal circumference was significantly greater and the time needed for restitution of peristaltics and defecation was significantly longer in the laparotomic cholecystectomy group compared to the group of laparoscopic cholecystectomy.
                Statistically significant impairments including hypoxia, hypocapnia and hyperventilation were observed in the patients submitted to laparotomic cholecystectomy, indicating the presence of objective respiratory risk, especially in elderly patients and patients with obstructive pulmonary diseases or cardiac insufficiency.
                Copyright 2000 S. Karger AG, Basel To analyze outcomes after open small-incision surgery (minilaparotomy) and laparoscopic surgery for gallstone disease in general surgical practice.
                This study was a randomized, single-blind, multicenter trial comparing laparoscopic cholecystectomy (LC) to minilaparotomy cholecystectomy (MC). Both elective and acute patients were eligible for inclusion. All surgeons normally performing cholecystectomy, both trainees under supervision and consultants, operated on randomized patients. LC was a routine procedure at participating hospitals, whereas MC was introduced after a short training period. All nonrandomized cholecystectomies at participating units during the study period were also recorded to analyze the external validity of trial results. The randomization period was from March 1, 1997, to April 30, 1999.
                Of 1,705 cholecystectomies performed at participating units during the randomization period, 724 entered the trial and 362 patients were randomized to each of the procedures. The groups were well matched for age and sex, but there were fewer acute operations in the LC group than the MC group. In the LC group 264 and in the MC group 150 operations were performed by surgeons who had done more than 25 operations of that type. Median operating times were 100 and 85 minutes for LC and MC, respectively. Median hospital stay was 2 days in each group, but in a nonparametric test it was significantly shorter after LC. Median sick leave and time for return to normal recreational activities were shorter after LC than MC. Intraoperative complications were less frequent in the MC group, but there was no difference in the postoperative complication rate between the groups. There was one serious bile duct injury in each group, but no deaths.
                Operating time was longer and convalescence was smoother for LC compared with MC. Further analyses of LC versus MC are necessary regarding surgical training, surgical outcome, and health economy. Intraabdominal structures may be damaged during blind introduction of the first trocar for laparoscopic operations. In this study, 150 patients with gallbladder lithiasis who underwent laparoscopy were randomly assigned to two groups, a blind (V group) or an open (H group), in order to compare the results and the rate of complications. No mortality was observed. Major complications occurred in 3/75 (4%) patients of the V group and in 1/75 (1.3%) patient of the H group (p < 0.05). Minor complications occurred in 5/75 (6.7%) patients of either group. The achievement of pneumoperitoneum required 4.5+/-0.4 min in the V group and 3.2+/-0.2 min in the H group (p < 0.05). The open laparoscopic technique is safer and faster than the blind approach; therefore, it is proposed that this approach be routinely used in all laparoscopic procedures. The use of smaller instruments during laparoscopic cholecystectomy (LC) has been proposed to reduce postoperative pain and improve cosmesis. However, despite several recent trials, the effects of the use of miniaturized instruments for LC are not well established. We hypothesized that LC using miniports (M-LC) is safe and produces less incisional pain and better cosmetic results than LC performed conventionally (C-LC).
                A patient- and observer-blinded, randomized, prospective clinical trial.
                A tertiary care, university-based hospital.
                Seventy-nine patients scheduled for an elective LC who agreed to participate in this trial were randomized to undergo surgery using 1 of the 2 instrument sets. The criteria for exclusion were American Society of Anesthesiologists class III or IV, age older than 70 years, liver or coagulation disorders, previous major abdominal surgical procedures, and acute cholecystitis or acute choledocholithiasis.
                Laparoscopic cholecystectomy performed with either conventional or miniaturized instruments.
                Patients' age, sex, operative time, operative blood loss, intraoperative complications, early and late postoperative incisional pain, and cosmetic results.
                Thirty-three C-LCs and 34 M-LCs were performed and analyzed. There were 8 conversions (24%) to the standard technique in the M-LC group. No intraoperative or major postoperative complications occurred in either group. The average incisional pain score on the first postoperative day was significantly less in the M-LC group (3.9 vs 4.9; P = .04). No significant differences occurred in the mean scores for pain on postoperative days 3, 7, and 28. However, 90% of patients in the M-LC group and only 74% of patients in the C-LC group had no pain (visual analog scale score of 0) at 28 days postoperatively (P = .05). Cosmetic results were superior in the M-LC group according to both the study nurse's and the patients' assessments (38.9 vs 28.9; P<.001, and 38.8 vs 33.4; P = .001, respectively).
                Laparoscopic cholecystectomy can be safely performed using 10-mm umbilical, 5-mm epigastric, 2-mm subcostal, and 2-mm lateral ports. The use of mini-laparoscopic techniques resulted in decreased early postoperative incisional pain, avoided late incisional discomfort, and produced superior cosmetic results. Although improved instrument durability and better optics are needed for widespread use of miniport techniques, this approach can be routinely offered to many properly selected patients undergoing elective LC. The aim of this study was to evaluate the effect of antibiotic prophylaxis on the development of infectious complications in laparoscopic cholecystectomy.
                A total of 208 patients undergoing elective laparoscopic cholecystectomy were randomized, double-blinded into one of two treatment arms: 1) cefazolin 1 g intravenously after induction of anesthesia and 2) no prophylactic antibiotics. The patients were followed-up for infectious complications for 30 days at the out-patient clinic. The data collected included age, sex, body mass index, ultrasonography findings, accompanying diseases, perforation during surgery, stone spillage, operation time, port of gallbladder delivery, suture material used for skin closure, preoperative and length of postoperative hospitalization, bile culture, pathology of the gallbladder, serum biochemical findings including alanine aminotransferase, aspartate aminotransferase, gammaglutamyl transpeptidase, bilirubin, alkaline phosphatase and glucose.
                Overall rate of infection was 3.36%. Four out of 105 patients who received antibiotics and 3 out of 103 patients who did not receive antibiotics developed infection. The difference was not statistically significant. Obesity and closing the skin with nylon sutures were found to be associated with increased rate of infectious complications.
                Cefazolin prophylaxis in low risk patients has no effect on postoperative infection rate in laparoscopic cholecystectomy. Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy.
                In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic cholecystectomy using two 10-mm and two 5-mm trocars (LC). Incisional pain at each port incision and overall pain were recorded for 1 week after the operation. Fatigue, nausea and vomiting, pulmonary function, and cosmetic results were also measured.
                Data from 52 patients were analyzed; eight patients were excluded from the study for various reasons. One patient was converted from 3.5-mm LC to LC due to technical problems with the 3.5-mm optic. In the 3.5-mm LC group (n = 25), incisional pain was significantly decreased in the 1st postoperative week as compared with the LC group (n = 27) (p <0.01). In both groups, pain scores at the supraumbilical 10-mm port were significantly higher compared with other port sites (p <0.05). The cosmetic results were significantly better in the 3.5-mm LC group (p <0.01). There were no significant differences in any of the other variables.
                The use of 3.5-mm trocars is feasible in LC, and it both reduces incisional pain and improves the cosmetic result. Our objective is to compare the results of laparoscopic cholecystectomy (LC) and common bile duct (CBD) exploration to those of endoscopic stone extraction and LC in patients with CBD lithiasis based on a prospective randomized study.
                From April 1997 until August 2000, 78 patients were assigned in two groups. Group A (n'36) patients underwent laparoscopic either direct or trancystic duct, CBD exploration and LC. Group B (n'42) patients were referred for endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (ES) for duct clearance and at a later stage LC was performed. Selection of patients of both groups was done, considering prognostic factors of a preliminary study.
                Laparoscopic duct clearance was achieved in 85.7% of patients while the respective percentage for the combined approach was 84.3%.
                Laparoscopic CBD exploration is not yet established as the gold standard procedure for choledocholithiasis and there is the need for further randomized trials and possibly future meta-analyses.
Currently, there is no evidence that three dimensional image is superior to two dimensional image in laparoscopic cholecystectomy.