Randomized clinical trial of laparoscopic cholecystectomy performed with mini-instruments. Randomized trial of laparoscopic cholecystectomy and mini-cholecystectomy. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study. Advantages of mini-laparoscopic vs conventional laparoscopic cholecystectomy: results of a prospective randomized trial. Minimizing ports to improve laparoscopic cholecystectomy. Randomized clinical trial of conventional cholecystectomy versus minicholecystectomy. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. [Laparoscopic cholecystectomy versus mini-lap-cholecystectomy. Results of a prospective, randomized study]. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial.
The outcomes after traditional laparoscopic cholecystectomy (LC; one 10-mm port, one 12-mm port and two 5-mm ports) and minilaparoscopic cholecystectomy (MLC; three 3-mm ports and one 12-mm port) for gallstone disease were compared.
                The study was a randomized, single-blind trial comparing LC with MLC. Only elective patients were eligible for inclusion. LC was a routine procedure at the institution in which the study was performed, whereas MLC was introduced after a short training period. The randomization period was from January to December 2001.
                Of 175 patients who had elective minimal access cholecystectomy during the randomization period, 135 entered the trial: 68 underwent LC and 67 underwent MLC. The groups were matched for age, sex and preoperative characteristics. Median (range) operating times for LC and MLC were similar (45 (20-120) and 50 (20-170) min respectively). Intraoperative and postoperative complication rates, the time for the patient to resume walking, eating and passing stools, and median hospital stay were the same in the two groups. The level of postoperative pain was lower in the MLC group at 1 h (P = 0.011), 3 h (P = 0.012), 6 h (P = 0.003), 12 h (P = 0.052) and 24 h (P = 0.034). Patients who had MLC received fewer injections of analgesic (P = 0.036) and more patients in this group expressed satisfaction with the cosmetic result (P = 0.001).
                MLC took a similar time to perform and caused less postoperative pain than the standard laparoscopic procedure. Reducing the port size further enhanced the advantages of laparoscopic over open cholecystectomy.
                Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Three hundred and ten patients having elective cholecystectomy were randomized to either laparoscopic cholecystectomy or mini-cholecystectomy. There were 155 patients in each group. Conversion to open cholecystectomy was significantly more common with laparoscopic cholecystectomy (13 versus 4 per cent) and complications were significantly more frequent with laparoscopic cholecystectomy (9 versus 3 per cent). If laparoscopic cholecystectomy was successful, hospital stay was significantly shorter than for mini-cholecystectomy (2 versus 3 days respectively), but overall the hospital stay was not significantly different. Postoperative analgesia requirements were reduced and return to normal activities and to work were faster after laparoscopic cholecystectomy. There was no significant cost difference between the two procedures. 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. 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. Minimizing the number and scope of ports used to perform laparoscopic cholecystectomy attempts to build on the improvements in postoperative pain control, rapid return to activity and work, patient satisfaction, and cosmetic result achieved by the laparoscopic method.
                We studied 141 patients in two sequential studies: the first a prospective randomized trial with 41 patients, and the second an examination of the more minimal procedure in 100 patients. In the randomized trial, patients underwent laparoscopic cholecystectomy with three ports: three 5-mm ports or two 10-mm ports and one 5-mm port. The 100 patients underwent the three 5-mm port procedure.
                In the randomized trial, differences were not statistically significant. However, on the average, the group with three 5-mm ports required less medication over less time, had less postoperative pain, and took less time to return to activity than the second group with larger ports. A statistically significant difference was found in incisional pain between the smaller group (21 patients) with two 10-mm ports and one 5-mm port and the larger group (100 patients) with three 5-mm ports, whether the measure was overall incisional pain (p = 0.014) or a comparison based on specific ports (p = 0.001). The percentage of cases requiring port enlargement to remove the gallbladder was not significantly different between the groups. There were no conversions to an open procedure, no fourth trocars added, and no complications. No patient required overnight hospitalization.
                Reducing the number and size of ports in laparoscopic cholecystectomy sustains or enhances the improvements initiated by performing laparoscopic rather than open cholecystectomy. In a comparison of microlaparoscopic procedures, patients undergoing the procedure with the shorter incisions experienced significantly less pain. The main argument for laparoscopic cholecystectomy in preference to open cholecystectomy appears to be based on less traumatic incisions inflicted on the abdominal wall. To investigate the effects of different incision lengths on patients following elective open cholecystectomy, a randomized clinical study was conducted.
                In this study 130 patients were randomly assigned to undergo either open cholecystectomy through a transverse subcostal incision of mean length 5.8 cm, so called minicholecystectomy (65 patients), or to undergo conventional cholecystectomy through a paracostal incision of mean length 13.1 cm (65 patients). The perception of pain after operation was measured by a visual analogue scale. To register late complications the mean(s.d.) hospitalization period after operation was extended to 11.5(1.2) days in the minicholecystectomy group and 15.4(2.5) days in the conventional cholecystectomy group.
                The perceived pain and analgesic requirements were found to be similar in both groups. Twelve of 65 patients in the minicholecystectomy group and four of 65 in the conventional cholecystectomy group developed wound haematoma.
                On the basis of this prospective randomized study, the hypothesis that a smaller incision length on the abdominal wall could lower the level of perceived pain, and therefore decrease the postoperative analgesic intake after minicholecystectomy, could not be confirmed. 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 ). Laparoscopic cholecystectomy (LCCE) was gaining acceptance rapidly, when several institutions could demonstrate the safety of this minimal invasive treatment modality. Nevertheless prospective randomised studies still are missing to prove the advantages of this new treatment modality in contrast to open cholecystectomy. 77 patients with symptomatic cholelithiasis were treated by LCCE (n = 40) or mini-lap CCE (n = 37) in a prospective, randomised study. As preliminary results, there were no differences in duration of anesthesia and operation time, perioperative complications or postoperative need for analgetics. Patients with LCCE had significant less postoperative pain, less restriction of total vital capacity and a shorter postoperative hospital stay as parameters of a diminished operative trauma. 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.
Miniport laparoscopic cholecystectomy can be completed successfully in more than 85% of patients. Patients, in whom elective miniport laparoscopic cholecystectomy was completed successfully, had lower pain than those who underwent standard laparoscopic cholecystectomy. However, because of the lack of information on its safety, miniport laparoscopic cholecystectomy cannot be recommended outside well-designed, randomised clinical trials.