A prospective randomized trial of laparoscopic versus open appendectomy.

BACKGROUND. Laparoscopic appendectomy is feasible, but whether it confers any advantage to patients with acute appendicitis is not known. We performed a randomized controlled trial to compare results of laparoscopic and open appendectomy in patients with signs and symptoms suggesting acute appendicitis who were seen by one surgical team. METHODS. Sixty-two consecutive patients were randomized, 30 to laparoscopy and 32 to a classical open appendectomy. Postoperative recovery, complications, and return to normal activities were compared in the two groups. RESULTS. The laparoscopy group were discharged earlier (2.5 vs 3.8 days, p less than 0.01). Postoperative complications were more frequent after open appendectomy. Follow-up showed less pain, shorter bed stay at home, and faster return to work and sport after laparoscopic appendectomy. CONCLUSIONS. This prospective randomized study shows that laparoscopic appendectomy is superior to open appendectomy in terms of hospital stay, postoperative complications, and return to normal activities and is recommended as the approach of choice in the management of acute appendicitis.     

Shockwave therapy for chronic Achilles tendinopathy: A double-blind,randomized clinical trial of efficacy

Background and purpose?Chronic Achilles tendinopathy is a painful condition and there are often unsatisfactory results with conservative treatment. Extracorporal shock-wave therapy (ESWT) has been introduced for the management of various soft tissue conditions. The objective of the study was to compare the effect of supplementing conservative treatment of chronic Achilles tendinopathy with ESWT or placebo.

Patients and methods?This was a randomized, double-blind, placebo-controlled trial. Patients assigned to nonoperative treatment of chronic achilles tendinopathy were randomized to receive either active ESWT or sham ESWT over 4 weeks. There were 48 patients (28 men) with a mean age of 47 (19–80) years. American Orthopaedic Foot and Ankle Society (AOFAS) score and pain were assessed before treatment, during the 4-week treatment period, and at 4, 8, and 12 weeks of follow-up.

Results?Both groups improved during the treatment and follow-up period. The mean AOFAS score increased from 74 (SD 12) to 81 (16) in the placebo group and from 70 (6.8) to 88 (10) in the intervention group (p = 0.05). Better results were seen in the intervention group at 8 and 12 weeks of follow-up (p = 0.01 and p = 0.04, respectively).

Interpretation?Extracorporal shock-wave therapy appears to be a supplement for the treatment of chronic Achilles tendinopathy.     

A prospective randomized trial of angelchik prosthesis versus Nissen fundoplication

A total of 61 patients with gastro-oesophageal reflux; resistant to medical therapy, were entered into a prospective randomized trial comparing the Angelchik antireflux prosthesis with Nissen's fundoplication. Both groups had a similar age and sex distribution and their reflux profiles were comparable. An Angelchik prosthesis was inserted in 30 patients and 31 underwent fundoplication. The mean duration of postoperative follow-up was 38 months. At clinical assessment 23 (77 per cent) of the Angelchik group were graded Visick grade I or II, compared with 29 (94 per cent) of the Nissen group. Assessment by 24 h pH monitoring and manometry between 3 and 6 months after operation showed that both procedures were equally effective in reducing reflux and increasing lower oesophageal sphincter pressure. However, long-term endoscopic follow-up revealed grade III oesophagitis in seven patients in the Angelchik group. No patient in the fundoplication group had grade III oesophagitis. Three of eight patients with strictures in the Angelchik group reported persistent dysphagia. All seven patients with strictures in the Nissen group were relieved of their dysphagia. Migration or erosion of the prosthesis did not occur. Three prostheses (10 per cent) were removed, two for dysphagia and one because of sepsis.     

Treatment of de Quervain tenosynovitis. A prospective study of the results of injection of steroids and immobilization in a splint

In a prospective study of non-operative treatment of de Quervain tenosynovitis, ninety-nine wrists of ninety-five consecutively seen patients who had this diagnosis had an injection of one milliliter of a 1 per cent lidocaine solution and one milliliter of a suspension containing forty milligrams of methylprednisolone acetate. Twelve patients (twelve wrists) were lost to follow-up. Of the remaining eighty-seven wrists, fifty-four (62 per cent) had a satisfactory outcome at a mean of eighteen months (minimum follow-up, twelve months). The duration of symptoms before treatment did not affect the outcome. The result in thirty-three wrists (38 per cent) was considered unsatisfactory. Thirty of these wrists were subsequently treated with operative release of the first dorsal compartment, and twenty-two (73 per cent) of the thirty were found to have a separate compartment for the extensor pollicis brevis. The prevalence of a separate compartment is significantly higher than that in the general population, as shown in anatomical studies of cadavera.     

Frozen shoulder-A prospective randomized clinical trial

AIM To compare the results of arthroscopic capsular release with intra-articular steroid injections in patients of frozen shoulder.METHODS Fifty-six patients with frozen shoulder were randomised to one of two treatment groups: Group 1, complete 360 degree arthroscopic capsular release and group 2, intra-articular corticosteroid injection(40 mg methyl prednisolone acetate). Both groups were put on active and passive range of motion exercises following the intervention. The outcome parameters were visual analogue scale(VAS) score for pain, range of motion and Constant score which were measured at baseline, 4, 8, 12, 16 and 20 wk after intervention.RESULTS All the parameters improved in both the groups. The mean VAS score improved significantly more in the group 1 as compared to group 2 at 8 wk. This greater improvement was maintained at 20 wk with P value of 0.007 at 8 wk, 0.006 at 12 wk, 0.006 at 16 wk and 0.019 at 20 wk. The Constant score showed a more significant improvement in group 1 compared to group 2 at 4 wk, which was again maintained at 20 wk with P value of 0.01 at 4, 8, 12 and 16 wk. The gain in abduction movement was statistically significantly more in arthroscopy group with P value of 0.001 at 4, 8, 12, 16 wk and 0.005 at 20 wk. The gain in external rotation was statistically significantly more in arthroscopy group with P value of 0.007 at 4 wk, 0.001 at 8, 12, and 16 wk and 0.003 at 20 wk. There was no statistically significant difference in extension and internal rotation between the two groups at any time. CONCLUSION Arthroscopic capsular release provides subjective and objective improvement earlier than intra-articular steroid injection.     

A prospective randomized trial comparing open versus laparoscopic appendectomy.

OBJECTIVE: The authors determined whether there was an advantage to laparoscopic appendectomy when compared with open appendectomy. SUMMARY/BACKGROUND DATA: The advantages of laparoscopic appendectomy versus open appendectomy were questioned because the recovery from open appendectomy is brief. METHODS: From January 15, 1992 through January 15, 1993, 75 patients older than 9 years were entered into a study randomizing the choice of operation to either the open or the laparoscopic technique. Statistical comparisons were performed using the Wilcoxon test. RESULTS: Thirty-seven patients were assigned to the open appendectomy group and 38 patients were assigned to the laparoscopic appendectomy group. Two patients were converted intraoperatively from laparoscopic appendectomies to open procedures. Thirty-one patients (81%) in the open group had acute appendicitis, as did 32 patients (84%) in the laparoscopic group. Mean duration of surgery was 65 minutes for open appendectomy and 87 minutes for laparoscopic appendectomy (p < 0.001). There were no statistically significant differences in length of hospitalization, interval until resumption of a regular diet, or morbidity. Duration of both parenteral and oral analgesic use favored laparoscopic appendectomy (2.0 days versus 1.2 days, and 8.0 days versus 5.4 days, p < 0.05). All patients were instructed to return to full activities by 2 weeks postoperatively. This occurred at an average of 25 days for the open appendectomy group versus 14 days for the laparoscopic appendectomy group (p < 0.001). CONCLUSIONS: Patients who underwent laparoscopic appendectomies have a shorter duration of analgesic use and return to full activities sooner postoperatively when compared with patients who underwent open appendectomies. The authors consider laparoscopic appendectomy to be the procedure of choice in patients with acute appendicitis.     

Hyaluronidase versus surgical excision of ganglia: a prospective,randomized clinical trial

This prospective, randomized clinical trial compared the treatment of ganglia by either hyaluronidase injection and aspiration or surgical excision. Fifty patients were randomly allocated to each group and 46 patients in the hyaluronidase group and 43 in the surgical group were available for follow-up at 1 year. Patients with ganglia treated with hyaluronidase had a recurrence rate of 77%, which was significantly higher (P<0.01) than the recurrence rate after surgery (24%).     

A prospective randomized trial of day-stay only versus overnight-stay laparoscopic cholecystectomy

BACKGROUND: Although the feasibility of laparoscopic cholecystectomy performed as day surgery has been established, cost and recovery time have not previously been evaluated in a prospective comparative fashion. METHODS: Patients were randomized to day stay only or overnight stay, and a nurse assessed the former postoperatively at home. All patients were reviewed weekly or as required if problems occurred. Costing comparisons were made between the two groups using Trendstar software. RESULTS: A total of 131 patients were evaluated after randomization (60 day-stay only patients and 71 overnight-stay patients). A total of 18.3% of the day-stay patients required in-hospital admission for nausea, vomiting, or pain, or after conversion to open operation; 18.3% of the overnight group required an extended length of stay for similar reasons. After discharge, two day-stay and three overnight-stay patients required readmission, only one had a significant complication. The mean times to return to normal activity averaged 1.8 weeks (SE: 0.1 weeks) and 1.9 weeks (SE: 0.1 weeks) for day-stay and overnight-stay groups, respectively (P = 0.63), and costs of $2732 (SE: $76) compared to $2835 (SE $110), respectively (P = 0.94). CONCLUSIONS: In the present randomized controlled study, day-stay management did not compromise postoperative patient outcome. In the setting of a major teaching hospital there was no cost advantage when compared to overnight-stay management.     

A prospective randomized trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy.

OBJECTIVE: The authors hypothesized that pancreaticogastrostomy is safer than pancreaticojejunostomy after pancreaticoduodenectomy and less likely to be associated with a postoperative pancreatic fistula. SUMMARY BACKGROUND DATA: Pancreatic fistula is a leading cause of morbidity and mortality after pancreaticoduodenectomy, occurring in 10% to 20% of patients. Nonrandomized reports have suggested that pancreaticogastrostomy is less likely than pancreaticojejunostomy to be associated with postoperative complications. METHODS: Between May 1993 and January 1995, the findings for 145 patients were analyzed in this prospective trial at The Johns Hopkins Hospital. After giving their appropriate preoperative informed consent, patients were randomly assigned to pancreaticogastrostomy or pancreaticojejunostomy after completion of the pancreaticoduodenal resection. All pancreatic anastomoses were performed in two layers without pancreatic duct stents and with closed suction drainage. Pancreatic fistula was defined as drainage of greater than 50 mL of amylase-rich fluid on or after postoperative day 10. RESULTS: The pancreaticogastrostomy (n = 73) and pancreaticojejunostomy (n = 72) groups were comparable with regard to multiple parameters, including demographics, medical history, preoperative laboratory values, and intraoperative factors, such as operative time, blood transfusions, pancreatic texture, length of pancreatic remnant mobilized, and pancreatic duct diameter. The overall incidence of pancreatic fistula after pancreaticoduodenectomy was 11.7% (17/145). The incidence of pancreatic fistula was similar for the pancreaticogastrostomy (12.3%) and pancreaticojejunostomy (11.1%) groups. Pancreatic fistula was associated with a significant prolongation of postoperative hospital stay (36 +/- 5 vs. 15 +/- 1 days) (p < 0.001). Factors significantly increasing the risk of pancreatic fistula by univariate logistic regression analysis included ampullary or duodenal disease, soft pancreatic texture, longer operative time, greater intraoperative red blood cell transfusions, and lower surgical volume (p < 0.05). A multivariate logistic regression analysis revealed the factors most highly associated with pancreatic fistula to be lower surgical volume and ampullary or duodenal disease in the resected specimen. CONCLUSIONS: Pancreatic fistula is a common complication after pancreaticoduodenectomy, with an incidence most strongly associated with surgical volume and underlying disease. These data do not support the hypothesis that pancreaticogastrostomy is safer than pancreaticojejunostomy or is associated with a lower incidence of pancreatic fistula.     

A prospective randomized clinical trial of liver preservation using high-odium versus high-potassium lactobionate/raffinose solution

Abstract High-odium as opposed to high-potassium lactobionate/raffinose preservation solution offers potential advantages in improving the quality of liver storage by reducing potassium-induced vasoconstriction and preventing hyperkalaemia on reperfusion. In our study we evaluated in a prospective trial (encompassing 40 consecutive cadaver donor hepatic retrievals and subsequent transplants) the efficacy of a high-odium formulation versus the standard high-potassium solution. Quality of preservation was assessed by clinical indices of liver function in the intraoperative and early postoperative phases, including measurements of requirements for blood and blood products and potassium, circulating liver enzymes and bilirubin. Frequencies of acute rejection episodes and primary non-function were also recorded. No significant differences were evident in any of the measured parameters. Thus a sodium-based solution can be used for hepatic preservation, advancing the possibility that it may be possible to develop a single storage solution for clinical multi-organ donor operations.     

Laparoscopic versus open appendectomy: prospective randomized trial

Although classic open surgery is simple, expeditious, and effective, it has some drawbacks, including wound sepsis, delayed recovery, operative difficulties, and possibility of unnecessary appendectomies for false appendicitis. The aim of this study was to assess the applicability and safety of laparoscopic appendectomy (LA) in a prospectively randomized trial. Seventy nonselective patients with suspected appendicitis were randomized to laparoscopic (n = 35, 17 male) or open appendectomy (n = 35, 15 male) and operated on an emergency basis. Operative findings, operating time, postoperative complications, and length of hospital stay were compared. We found that LA is associated with a shorter hospital stay, fewer postoperative complications, and better diagnostic accuracy, and it is recommended as the procedure of choice for the diagnosis and management of acute appendicitis.     

Night splint treatment for plantar fasciitis. A prospective randomized study

A prospective randomized study of 116 patients with plantar fasciitis was performed to determine the effectiveness of adjuvant night splint therapy in relieving the acute symptoms of plantar fasciitis. Patients were randomized into one of two groups. Patients in Group 1 were treated with 1 month of oral antiinflammatory medication, Achilles stretching exercises, and shoe recommendations. Patients in Group 2 received identical treatment but also used a dorsiflexion night splint for 3 months. Blinded clinical review of patients was performed at 4, 6, and 12 weeks. Health status data Short Form 36 also was collected at these times and again at an average 19 months of followup. Overall, 68% of patients reported improvement with this nonoperative protocol for a 12-week period. No statistical difference was seen with the presence or absence of a night splint. In addition, no differences in improvement rates were observed with gender, duration of antecedent symptoms, the presence of bilateral symptoms, or the presence of a heel spur. Age older than 45 years did prove to be a statistically significant poor prognostic factor for improvement at the 12-week follow-up. Short Form 36 data obtained at baseline showed significantly lowered perception of health when compared with age matched controls. Patients in both treatment groups had significant improvement in Short Form 36 scores with 12 weeks of conservative care.     

A prospective randomized controlled trial comparing nonstented versus stented ureteroscopic lithotripsy

PURPOSE: A prospective randomized controlled trial was performed to determine whether stents may be eliminated after uncomplicated ureteroscopic lithotripsy for ureteral stones. MATERIALS AND METHODS: A total of 58 patients underwent uncomplicated ureteroscopic intracorporeal lithotripsy. After stone fragmentation patients were randomized to a nonstented (29) or a stented (29) treatment group. Intracorporeal lithotripsy was performed with the holmium laser in 57 cases and by electrohydraulic lithotripsy in 1 without balloon dilation or the extraction of stone fragments. Patients were followed 1, 6 and 12 weeks postoperatively. In stented cases the stent was removed at 1 week. Outcome measures included postoperative symptoms assessed with a visual analog scale, postoperative analgesic requirements, complications and the stone-free rate. RESULTS: At 1 week the symptoms of flank pain, abdominal pain, dysuria and frequency were significantly greater in the stented group (p <0.005). There were no differences in symptoms in the groups at subsequent followup visits. There was no difference in treatment groups in terms of the amount of analgesic required in the recovery room or during 1 week after ureteroscopy. Similarly there was no difference in the number of patients requiring antiemetics. One patient in the stented group required hospitalization for genitourinary sepsis and 1 patient in the nonstented group visited the emergency room for postoperative vomiting. The stone-free rate was 100% in each group. CONCLUSIONS: These results demonstrate that after ureteroscopic intracorporeal lithotripsy with the holmium laser patients with a stent have significantly greater irritative and painful symptoms than those without a stent in the early postoperative period. There was no difference in nonstented and stented ureteroscopy with respect to complications or stone-free status. Therefore, we believe that routine stenting after ureteroscopic intracorporeal lithotripsy with the holmium laser is not required as long as the procedure is uncomplicated and performed without balloon dilation of the ureteral orifice.     

Surgical techniques in hepatic resections: Ultrasonic aspirator versus Jet-Cutter. A prospective randomized clinical trial

AIM OF THE STUDY: For all resection-techniques of liver tissue intra- and post-operative blood-loss remains an important problem. Two novel resection-techniques the ultrasound-aspirator (CUSA) and the water-jet dissector (Jet-Cutter) appear to offer significant advantages regarding this problem. Aim of the present prospective clinical study was the comparison of these dissection techniques.MATERIAL AND METHODS: Prospective randomized study with the end points blood-loss, length of surgery, tissue trauma and long-term survival.FINDINGS: Significant differences between both procedures with Jet-Cutter (n = 31) versus ultrasonic surgical aspirator CUSA (n = 30) were observed regarding length of resection and complete liver ischemia time (Pringle-time). Here significant advantages of the jet-cutter-technique were observed with 28 +/- 11 minutes length of resection versus 46 +/- 19 minutes and 29 +/- 12 minutes Pringle-time versus 39 +/- 16 minutes. Furthermore, significant fewer blood transfusions were required following jet-cutter-resection with a mean of 1.5 blood units vs. 2.5 blood units using the CUSA. No differences were observed regarding postoperative long-term survival.CONCLUSIONS: The jet-cutter-technique is a fast and safe surgical procedure for liver resections and offers an attractive therapeutic alternative for various indications in liver surgery.     

Drainage after cholecystectomy. A prospective randomized clinical trial.

This prospective clinical study was done to assess the efficacy of postcholecystectomy drainage. A total of 173 cholecystectomized patients were randomized into two groups; group A (86 patients) without drainage and group B (87 patients) with drainage. Group B included two types of patients; B1 (52 patients) with suction drain and B2 (35 patients) with gravity drain. Evidence of wound infection, chest complications, and duration of hospital stay were recorded in every case. Ninety five patients were assessed for chest complications and subhepatic collection by chest x-ray and abdominal ultrasonography. In group B patients the total amount of fluid drained was measured. The results were analysed by appropriate statistical methods. There was no significant difference in the rate of wound infection or atelectasis in either group, although there was apparent increase of lung complications and subhepatic collections in Group B1. The average postoperative hospital stay was significantly increased in group B patients. Considering all the parameters of this study, it was found that drainage with gravity was attended with the least morbidity.     

A randomized prospective trial of cold storage versus pulsatile perfusion for cadaver kidney preservation

In a randomized trial conducted in 9 Ontario transplant centers, 107 cadaver kidney donors were randomized so that both kidneys were preserved either by simple cold storage (CS) or by pulsatile perfusion (PP). After exclusions and losses to follow-up, there were 90 patients in the CS group and 91 in the PP group. Total preservation times were similar in the two groups (27.7 +/- 12 and 30.5 +/- 10 hr), as was the proportion of kidneys with long (greater than 36 hr) storage times (21% and 26%). Twelve-month graft survival was 70% for CS and 75% for PP (not significant, NS); patient survival was 89% for CS and 95% for PP (NS). The incidence of kidneys that never functioned was also similar in the two groups (14% vs. 15%, respectively). However, the risk of early, reversible graft dysfunction was significantly higher for CS (44%) than for PP (31%). The same effect was observed with two independent methods of assessment of graft function. The chief effect of PP on renal function was in reduction of the mean serum creatinine at 1 week (632 mumol/L for CS vs. 403 mumol/L for PP, P less than .001). There was no significant influence of storage mode on the rapidity of urine output or number of dialyses required. No apparent effect of cyclosporine on the results with either preservation method was seen. We conclude that the case for retention of PP for kidney preservation now rests on its ability to achieve slightly better initial function than CS. However, the mild dysfunction observed with CS did not appear to translate into long-term detriment. When these considerations are weighed against the increased cost of PP, the advantage may lie with cold storage.     

Low-pressure pneumoperitoneum versus standard pneumoperitoneum in laparoscopic cholecystectomy, a prospective randomized clinical trial

Background  Post-laparoscopic pain syndrome is well recognized and characterized by abdominal and particularly shoulder tip pain; it occurs frequently following laparoscopic cholecystectomy. The etiology of post-laparoscopic pain can be classified into three aspects: visceral, incision, and shoulder. The origin of shoulder pain is only partly understood, but it is commonly assumed that the cause is overstretching of the diaphragmatic muscle fibers owing to a high rate of insufflations. This study aimed to compare the frequency and intensity of shoulder tip pain between low-pressure (7 mmHg) and standard-pressure (14 mmHg) in a prospective randomized clinical trial. Methods  One hundred and forty consecutive patients undergoing elective laparoscopic cholecystectomy were randomized prospectively to either high- or low-pressure pneumoperitoneum and blinded by research nurses who assessed the patients during the postoperative period. The statistical analysis included sex, mean age, weight, American Society of Anesthesiologists (ASA) grade, operative time, complication rate, duration of surgery, conversion rate, postoperative pain by using visual analogue scale, number of analgesic injections, incidence and severity of shoulder tip pain, and postoperative hospital stay. p < 0.05 was considered indicative of significance. Results  The characteristics of the patients were similar in the two groups except for the predominance of males in the standard-pressure group (controls). The procedure was successful in 68 of 70 patients in the low-pressure group compared with in 70 patients in the standard group. Operative time, number of analgesic injections, visual analogue score, and length of postoperative days were similar in both groups. Incidence of shoulder tip pain was higher in the standard-pressure group, but not statistically significantly so (27.9% versus 44.3%) (p = 0.100). Conclusions  Low-pressure pneumoperitoneum tended to be better than standard-pressure pneumoperitoneum in terms of lower incidence of shoulder tip pain, but this difference did not reach statistical significance following elective laparoscopic cholecystectomy.     

Subcuticular closure versus Dermabond: a prospective randomized trial

2-Octylcyanoacrylate tissue adhesive (Dermabond, Ethicon, Inc, Somerville, NJ) is being used successfully for closure of minor lacerations. To date, however, there have been no studies evaluating its use in the operating room for surgical incisions. We conducted a prospective randomized trial to compare the closure of inguinal herniorrhaphy incisions using 2-octylcyanoacrylate tissue adhesive (Dermabond) with closures using 4-0 Monocryl (Ethicon, Inc) in a running subcuticular closure. A total of 46 incisions were randomized at the time of closure. Of these incisions 24 were randomized to Dermabond closure (TA) and 22 were randomized to subcuticular closure (SC). Performance measures included: time for closure, wound complications, and cosmesis. Cosmesis was evaluated by blinded evaluation of photographs of the incisions taken 4 weeks after surgery. Closure times for the TA group were faster than in the SC group (mean of 155 vs 286 seconds; P < 0.001). Wound complications were higher in the TA group (P = 0.045). Cosmesis was also felt to be better in the SC group with a score of 4.2 versus 3.88, but this did not reach statistical significance. Although the use of Dermabond did result in faster wound cultures it also resulted in an increase in wound complications. The difference in mean cosmetic score for each group was not statistically significant but trended toward better scores in the SC group. Based on these findings we do not feel Dermabond is an acceptable alternative to subcuticular suture closure in inguinal herniorrhaphy incisions.