Randomized clinical trial of conventional cholecystectomy versus minicholecystectomy. Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Randomized trial of laparoscopic cholecystectomy and mini-cholecystectomy. Laparoscopic vs. open cholecystectomy in patients aged 65 and older. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study. Patient recovery following cholecystectomy through a 6 cm or 15 cm transverse subcostal incision: a prospective randomized clinical trial. [Laparoscopic cholecystectomy versus mini-lap-cholecystectomy. Results of a prospective, randomized study]. Laparoscopic versus open cholecystectomy: hospitalization, sick leave, analgesia and trauma responses. Mini-lap cholecystectomy--an attractive alternative to conventional cholecystectomy.
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. We report a prospective randomised comparison between laparoscopic and small-incision cholecystectomy in 200 patients which was designed to eliminate bias for or against either technique.
                Patients were randomised in the operating theatre and anaesthetic technique and pain-control methods were standardised. Four experienced surgeons did both types of procedure. Identical wound dressings were applied in both groups so that carers could be kept blind to the type of operation.
                There was no significant difference between the groups for age, sex, body mass index, and American Society of Anaesthesiologists grade. Laparoscopic cholecystectomy took significantly longer than small-incision cholecystectomy (median 65 [range 27-140] min vs 40 [18-142] min, p<0.001). The operating time included operative cholangiography which was attempted in all patients. We found no significant difference between the groups for hospital stay (postoperative nights in hospital, median 3-0 [1-17] nights for laparoscopic vs 3-0 [1-14] nights for small-incision, p=0.74), time back to work for employed persons (median 5-0 weeks vs 4.0 weeks; p=0.39), and time to full activity (median 3-0 weeks vs 3.0 weeks; p=0.15).
                Laparoscopic cholecystectomy takes longer to do than small-incision cholecystectomy and does not have any significant advantages in terms of hospital stay or postoperative recovery. 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. Laparoscopic cholecystectomy (LC) has displaced open cholecystectomy (OC) in the management of cholelithiasis. However, there are few studies on the role of this technique in patients who run a high risk of surgical complications. We performed a prospective study in 264 patients aged >65 years undergoing surgery for symptomatic cholelithiasis. They were divided into two groups according to the surgical technique performed: OC (131 patients) and LC (133 patients). Conversion from LC to OC was necessary in 11 patients (8.3%). Mean surgery time was 70.9 min for the OC group and 75 min for the LC group. The LC group had a lower rate of postoperative complications (13.53%) than the OC group (23.6%). The incidence of mild complications was similar in both groups; however, the rate of moderate complications was significantly higher in the OC group. Hospital stay was significantly longer in the OC group (9.9 days) than in the LC group (3.71 days). These results suggest that LC should be indicated in elderly patients, as they are better than those obtained with with OC and involve a lower morbidity rate and shorter hospital stay. 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 effect of incision length on patient recovery following cholecystectomy has not been investigated previously. In this study, 30 patients with symptomatic gallstones were randomized to cholecystectomy through a 6 cm or 15 cm transverse subcostal incision. Postoperative hospital stay was significantly shorter in the 6 cm incision group (median 3 days vs 5 days; P = 0.0069 Mann-Whitney U-test). In the 6 cm group analgesic requirements were reduced (median 2.5 vs 4.5 intramuscular opiate injections per patient) and recovery of depressed postoperative pulmonary function (FVC and FEV1) was faster (3% difference between groups on day 1 and 7% on day 3), although these differences did not achieve statistical significance. These results suggest that the length of incision may influence patient recovery following elective cholecystectomy. This has important implications as surgery carried out through shorter and less traumatic incisions may offer a cost-effective alternative to laparoscopic cholecystectomy. Moreover, some surgeons may find mini-laparotomy cholecystectomy easier to adopt than laparoscopic techniques. 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. Laparoscopic cholecystectomy has rapidly become established as the treatment of choice for cholecystolithiasis. There is very little evidence, however, to support the claimed benefit to patients. In the present study 30 consecutive patients below the age of 65 years without acute cholecystitis and with no signs of common bile duct stones were randomized to laparoscopic or conventional open cholecystectomy. Median (interquartile range) intravenous consumption of pethidine with a patient-controlled injection device between 13 and 24 h after surgery was 125 (62-175) mg in patients who underwent the laparoscopic procedure and 200 (150-250) mg in those who had open operation. Urinary adrenaline and cortisol levels as well as those of plasma glucose, C-reactive protein and interleukin 6 were increased after surgery in both groups of patients, but without any significant difference between them. The mean(s.d.) duration of postoperative hospital stay (2.8(0.8) versus 1.8(0.6) days) and sick leave (24.0(4.4) versus 11.7(4.1) days) was significantly longer with open than laparoscopic cholecystectomy. The findings demonstrate obvious advantages of laparoscopic surgery as regards postoperative pain and convalescence, although factors reflecting the magnitude of trauma did not differ. A prospective study was conducted to determine the safety and efficacy of cholecystectomy through a 5 cm transverse abdominal incision. 181 consecutive patients who underwent elective cholecystectomy for symptomatic gall stone disease in a single surgical unit at the All India Institute of Medical Sciences, New Delhi between December 1990 to February 1992, were prospectively randomized into 5 cm transverse and midline incision groups. Operative time, blood loss, post-operative stay and complications were compared in the two groups. Ninety seven patients were included in the transverse incision group and 84 patients in the midline group. Cholecystectomy could be safely performed through a 5 cm transverse incision in 84 patients (86.8%) without increase in operative complications, morbidity or mortality. In another 84 patients cholecystectomy was performed through a midline incision. The average operating time and blood loss were comparable in both groups. The average post-operative stay in 5 cm transverse incision group was 2.6 days (range 1-4 days) and in the midline group was 4.0 days (range 3-5 days). There were 7 post-operative complications (all wound infections) in the 5 cm transverse group and 12 post-operative complications (10 wound infections and 2 pneumonitis) in the midline group. However, the difference in wound infection rate was not statistically significant (p > 0.1). In Conclusion, Cholecystectomy can be safely performed through a 5 cm transverse incision.
Small-incision and open cholecystectomy seem to be equivalent regarding risks of complications, but the latter method is associated with a significantly longer hospital stay. The quicker recovery of small-incision cholecystectomy compared with open cholecystectomy confirms the existing preference of this technique over open cholecystectomy.