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. Minicholecystectomy vs conventional cholecystectomy: a prospective randomized trial--implications in the laparoscopic era. Mini-lap cholecystectomy--an attractive alternative to conventional cholecystectomy. Minilaparoscopic and laparoscopic cholecystectomy: a comparative study. Cost-effectiveness analysis of laparoscopic versus minilaparotomy cholecystectomy for gallstone disease. A randomized 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. The objective of this study was to compare results of elective "open" conventional cholecystectomy (CC) to those of minicholecystectomy (MC). A clinical prospective, randomized trial was designed. The setting was an academic general surgical unit. In the CC group were 26 patients; in the MC group were 24 patients. In the CC group a conventional open cholecystectomy was performed through a subcostal incision; in the MC group operation through an initial 5-cm subcostal incision was done. Mean length of wound was 14.4 cm and 5.4 cm in the two groups, respectively (p < 0.001). Mean operative time was 60 and 59 minutes, respectively. Mean operative difficulty, estimated on a 1-10 scale, was 3.4 and 5.6, respectively (p < 0.05). Mean postoperative analgesia requirements (number of doses of 10 mg morphine sulphate) were 5.8 and 4.0, respectively (p = 0.002). Mean duration of hospitalization was 4.7 and 3.0 days, respectively (p < 0.001). Mean "overall patient satisfaction," estimated on 1-10 scale, was 6 and 8.3, respectively (p = 0.002). We conclude that Minicholecystectomy offers less pain, earlier recovery, and better cosmetic results than the conventional "open" procedure. Published results of MC compare favorably with those of laparoscopic procedures. The implications of these results in the "laparoscopic era" are discussed. 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. To evaluate the feasibility and safety of the minilaparoscopic cholecystectomy (MLC) and to compare the clinical benefits experienced by patients who undergo MLC with those who undergo laparoscopic cholecystectomy (LC) or 5-mm laparoscopic cholecystectomy (5-mm LC).
                Prospective consecutive study.
                A tertiary referral center.
                From September 1, 2000, through June 30, 2001, 90 patients with symptomatic gallstones were randomized to undergo 1 of these 3 procedures.
                Minilaparoscopic cholecystectomy, LC, and 5-mm LC.
                Duration of surgery, loss of blood, length of hospital stay, resumption of solid food intake, quantity of analgesic dosage administered, development of complications, degree of pain at ports 24 and 48 hours after surgery, and overall cosmetic result.
                Subsequent to excluding 6 patients who were converted to LC, there were 30 patients in the LC group, 29 patients in the 5-mm LC group, and 25 patients in the MLC group. The MLC necessitated a longer time to complete the procedure than was the case for the other 2 procedures. There was no notable difference in the mean dosage of the meperidine hydrochloride (Pethidine) administered between the LC and MLC groups, but an apparent increase in the analgesia requirements for the 5-mm LC group was noted when compared with those of the other 2 groups. There was no remarkable difference in terms of blood loss, resumption of solid food intake, hospital stay subsequent to surgery, or surgical-related complication between these 3 groups. The MLC group did have a lower pain score in the subxyphoid port only at 24 hours after surgery compared with the other 2 groups. The cosmetic results were evaluated and no notable difference was noted at 1 week, 1 month, and 6 months after surgery.
                Although this study has demonstrated the feasibility and safety of the MLC, it does require a longer surgical time and reflects a reasonably high possibility for the conversion to LC. Furthermore, the MLC did not provide any notable clinical benefit for the tested patients compared with those patients in the LC group. We concluded that there is no reason for the MLC to become the universally accepted mode of treatment for symptomatic gallstones before further improvements are made in the technique and instrumentation. To evaluate the total cost of minilaparotomy cholecystectomy (MC) and laparoscopic cholecystectomy (LC) and perform a cost-effectiveness (CE) analysis.
                One hundred adult subjects with painful gallstone disease were randomized: 59 cases for LC and 41 cases for MC. Patients with gallstones shown on ultrasound with normal common bile duct and no history of icterus were included after an informed consent. Cases with acute cholecystitis and raised alkaline phosphatase were excluded. LC was performed using CO2 insufflation and a Storz 2D video camera. MC was done by transverse rectus cutting incision. Outcome was coded as success or failure. Success was defined as operation without injury to bile duct, viscera or vessels, minimal pain and discomfort at 4 weeks, no wound infection up to 4 weeks, and resumption of work within 2 weeks of operation. The total cost of each case included cost of investigations, cost of disposable articles for operation, cost of drugs, cost of hospital stay, and cost of operation including anesthesia. LC and MC were done with reusable instruments. A "societal viewpoint" has been taken in the cost calculations.
                There were 50/59 successful outcomes in LC and 15/40 outcomes in MC group. Total cost for LC was 386,769 rupees (Rs) and for MC was Rs 205,041. CE in LC was Rs 7,735 and in MC was Rs 13,669. Incremental CE ratio comparing LC with MC was 3,028.33.
                LC is a more cost-effective method for treatment of gallstone disease.
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.