Primary immunosuppression with mycophenolate mofetil and antithymocyte globulin for kidney transplant recipients of a suboptimal graft

BACKGROUND: In renal transplantation the beneficial immunosuppressive effects of cyclosporin (CsA) may be curtailed by its nephrotoxicity, specially in patients receiving a cadaveric allograft from suboptimal donors or at risk of delayed graft function. Mycophenolate mofetil (MMF) and antithymocyte globulin (ATG) have each demonstrated to be potent immunosuppressants in renal transplantation. In a prospective analysis we have studied the results at 6 months of the combination of MMF, ATG and low-dose steroids in patients with low immunological risk receiving a first cadaveric renal allograft from a suboptimal donor or at risk of delayed graft function. METHODS: Patients with preformed reactive antibodies < 500% receiving a first graft from a suboptimal donor (age > or = 40 years, non-heart-beating, acute renal failure, arterial hypertension) or at risk of delayed graft function (cold ischaemia time > or = 24 h) were eligible for this open single-arm pilot trial. From September 1996 to March 1997 we recruited 17 patients. They were treated with MMF 2 g p.o. preoperatively, and after transplantation at 3 g/day; rabbit ATG i.v. at 2 mg/kg preoperatively, and 1.5 mg/kg/day the first day after transplantation, followed by four doses of 1 mg/kg on alternate days; prednisone was given at 0.25 mg/kg/day and reduced progressively to 0.1 mg/kg/day at 3 months. Primary outcomes were incidence of biopsy-proven acute rejection, delayed graft function, opportunistic infections, graft and patient survival, and the need for introduction of CsA treatment. RESULTS: delayed graft function occurred in two cases (12%). Four of 17 patients (24%) had a biopsy-proven acute rejection (2 grade I and 2 grade II) within the first 3 months after transplantation. CsA was added in two cases with grade II biopsy-proven acute rejection, and in one with grade I biopsy-proven acute rejection. In one patient MMF was replaced by CsA because of gastrointestinal intolerance. Mean serum creatinine 6 months after transplantation was 159+/-59 micromol/1. Cytomegalovirus tissue invasive disease occurred in one patient (6%). At 6 months follow-up all patients are alive with functioning allografts. CONCLUSIONS: These preliminary results suggest that in low-immunological-risk patients who receive a suboptimal renal allograft or at risk of delayed graft function, the combination of MMF, ATG, and steroids is an efficient immunosuppressive regime that may avoid the use of CsA in 70% of the recipients.     

Steroid-free immunosuppression after kidney transplantation with antithymocyte globulin induction and cyclosporine and mycophenolate mofetil maintenance therapy

BACKGROUND: Our goal in clinical renal transplantation is to find immunosuppressive procedures that not only promote long-term patient and graft survival but also improve the overall well-being of the patients. METHODS: In a retrospective consecutive clinical study with historical controls, 68 patients were discharged from our center with functioning grafts between September 1995 and December 1997. Patients received steroid-free immunosuppression using an initial 10-day antithymocyte globulin induction and maintenance therapy with cyclosporine and mycophenolate mofetil (MMF). No steroids were given. RESULTS: After an observation for up to 2.5 years (median 488 days, range 127 to 945 days), 66 patients (one died from sepsis after 6 months, and one died of peritonitis after returning to dialysis) were alive and well. Sixty-four grafts were functioning well, hemolytic uremic syndrome recurred in one graft, one graft had to be removed for noncompliance, and two patients returned to dialysis after chronic rejection-one after 8 months (the patient who died in peritoneal dialysis) and one (a third graft in an antibody-positive patient) 16 months after transplantation. We observed only 10 acute rejections (15%), a rate significantly lower (P=0.0006) than the 71 acute rejections observed in 190 previous consecutive transplants (37.4%) treated without MMF but otherwise after exactly the same protocol. In further comparison, the MMF-treated group also showed an equivalent (P=NS) rate of cytomegalovirus infections and a lower rate (P<0.00005) of Epstein-Barr virus infections. Graft function was excellent (median serum creatinine below 200 micromol/L at 1 year), and no malignancies were observed in the MMF-treated patients. Side effects were mainly leukopenia and two gastrointestinal disturbances. CONCLUSIONS: Our first-line, steroid-free immunosuppressive protocol allows initial graft function, provides a safe level of long-term graft survival and function with a very low rejection rate, gives an acceptable rate of side effects, and possesses the potential for lowering the incidence of chronic rejection over the long-term. Compared with protocols that discontinue steroids after the initial posttransplant period, a steroid-free protocol avoids the increased risk of infection and body disfigurement in the early posttransplant period. It also avoids the long-term risks of steroid use and the increased risks of rejection when the steroids are withdrawn.     

A randomized trial comparing cyclosporine induction with sequential therapy in renal transplant recipients

Calcium antagonists may reduce the nephrotoxicity of cyclosporine (CsA), allowing CsA to be introduced immediately after renal transplantation and thereby obviating the need for sequential induction therapy with a monoclonal or polyclonal antibody. To test this hypothesis, in a pilot feasibility trial 100 cadaveric or one-haplotype-mismatched living-related renal transplant recipients were randomized to either (1) sequential therapy with anti-thymocyte globulin (ATG) (ATGAM; Upjohn, Kalamazoo, MI) 20 mg/kg/d for 7 to 14 days until renal function was established and CsA (Sandimmune; Sandoz, East Hanover, NJ) was started, or (2) CsA 8 mg/kg/d begun immediately before surgery with diltiazem (Cardizem; Marion Merrell Dow, Kansas City, MO) 60 mg sustained release twice daily. Acute rejection episodes during the first 90 days were not different with ATG versus CsA induction (42% v 28%; P = 0.142 by chi-square analysis). Graft failures (10% v 16%; P = 0.372) and the incidence of delayed graft function (28% v 34%; P = 0.516) were also similar with ATG compared with CsA. ATG caused lower platelet counts (138 +/- 59 x 10(3) v 197 +/- 75 x 10(3) at 7 days; P < 0.001) and lower white blood cell counts (9.6 +/- 4.6 x 10(3) v 12.3 +/- 4.9 x 10(3) at 7 days; P = 0.003). Diltiazem reduced the dose of CsA required to maintain target blood levels (479 +/- 189 mg/d v 576 +/- 178 mg/d at 14 days; P = 0.015). There were no statistically significant differences between the groups in serum creatinine levels at days 1, 3, 5, 7, 14, 28, 60, or 90. The results of this pilot feasibility trial suggest that prophylactic treatment with CsA and diltiazem may be equally effective and less toxic than ATG induction after renal transplantation.     

A prospective randomized study comparing a catheter-valve with a standard drainage system

OBJECTIVE: To determine if the use of a catheter-valve rather than a standard drainage system decreases the morbidity associated with the use of a long-term catheter. PATIENTS AND METHODS: One hundred patients undergoing long-term catheterization were recruited into a prospective randomized study to investigate the acceptability and determine any increase in infection associated with the use of a catheter-valve, compared with the standard drainage system. Each patient participated in the study protocol for 3 months, during which the frequency of urinary tract infection was assessed, and the patients' views obtained using a standard questionnaire and by interview. RESULTS: Ninety-four patients completed the study; most (92%) were happy or satisfied with the valve, as opposed to only 35% of those using a standard drainage bag. There was no significant difference between the groups in the incidence of urinary tract infections. CONCLUSION: The patients who used the standard drainage system felt their level of activity was impaired, whereas the group who were using the valve did not. In the long-term the valve was cheaper and caused less morbidity, but because it is constructed to allow one-way flow, this was not associated with an increase in the incidence of urinary tract infections.     

Low-dose aspirin for oocyte donation recipients with a thin endometrium: prospective, randomized study

OBJECTIVE: To evaluate the effect of low-dose aspirin use in oocyte donation recipients with an endometrial thickness of < 8 mm. DESIGN: A prospective, randomized study. SETTING: An oocyte donation program in a private infertility practice. PATIENT(S): Twenty-eight recipients undergoing oocyte donation who failed to develop an endometrial thickness of at least 8 mm in a previous evaluation cycle. INTERVENTION(S): Fifteen recipients received low-dose aspirin (81 mg/d) in addition to standard hormone replacement for an oocyte donation cycle. The remaining 13 recipients did not receive aspirin. MAIN OUTCOME MEASURE(S): Clinical pregnancy rates, delivery rates, implantation rates, and change in endometrial thickness were compared in the aspirin and nonaspirin groups. RESULT(S): There was no demonstrable increase in endometrial thickness in the aspirin-treated group. However, there was a statistically significant increase in implantation rates in the aspirin-treated group (24% versus 9%) and in implantation rates and clinical pregnancy rates in the aspirin-treated group when the final endometrial thickness was < 8 mm. CONCLUSION(S): Low-dose aspirin therapy improves implantation rates in oocyte donation recipients with a thin endometrium.     

1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation

STUDY DESIGN: This prospective study analyzed the influence of transpedicular instrumented on the operative treatment of patients with degenerative spondylolisthesis and spinal stenosis. OBJECTIVES: To determine whether the addition of transpedicular instrumented improves the clinical outcome and fusion rate of patients undergoing posterolateral fusion after decompression for spinal stenosis with concomitant degenerative spondylolisthesis. SUMMARY OF BACKGROUND DATA: Decompression is often necessary in the treatment of symptomatic patients who have degenerative spondylolisthesis and spinal stenosis. Results of recent studies demonstrated that outcomes are significantly improved if posterolateral arthrodesis is performed at the listhesed level. A meta-analysis of the literature concluded that adjunctive spinal instrumentation for this procedure can enhance the fusion rate, although the effect on clinical outcome remains uncertain. METHODS: Seventy-six patients who had symptomatic spinal stenosis associated with degenerative lumbar spondylolisthesis were prospectively studied. All patients underwent posterior decompression with concomitant posterolateral intertransverse process arthrodesis. The patients were randomized to a segmental transpedicular instrumented or noninstrumented group. RESULTS: Sixty-seven patients were available for a 2-year follow-up. Clinical outcome was excellent or good in 76% of the patients in whom instrumentation was placed and in 85% of those in whom no instrumentation was placed (P = 0.45). Successful arthrodesis occurred in 82% of the instrumented cases versus 45% of the noninstrumented cases (P = 0.0015). Overall, successful fusion did not influence patient outcome (P = 0.435). CONCLUSIONS: In patients undergoing single-level posterolateral fusion for degenerative spondylolisthesis with spinal stenosis, the use of pedicle screws may lead to a higher fusion rate, but clinical outcome shows no improvement in pain in the back and lower limbs.     

Trabeculectomy with releasable sutures: a prospective, randomized pilot study

OBJECTIVE: To compare the short-term and long-term efficacy of using releasable sutures vs conventional interrupted sutures for scleral flap suturing in trabeculectomy. DESIGN: A prospective randomized study. SETTING: A university-affiliated referral eye hospital. PATIENTS: Thirty consecutive patients requiring trabeculectomy for uncontrolled primary glaucoma. INTERVENTION: Fifteen patients underwent trabeculectomy with permanent interrupted sutures; the same number underwent trabeculectomy with releasable sutures. MAIN OUTCOME MEASURES: Incidence of short-term shallowing of anterior chamber or hypotony and related complications, and long-term intraocular pressure control and bleb score. RESULTS: The mean percentage reduction in intraocular pressure on day 1 in the group with releasable sutures was 55.2%, while only a 0.8% reduction in anterior chamber depth was noted. This compared with figures of 59.3% and 10.1%, respectively, in the group without releasable sutures. Hypotony (intraocular pressure < or =6 mm Hg) was noted in 8 (53%) of cases without releasable sutures and 3 (20%) of cases with releasable sutures. Shallow anterior chamber (central anterior chamber depth, < or =1 mm) was noted in 5 (33%) of cases without releasable sutures and 1 (7%) of cases with releasable sutures. The mean +/- SD final bleb score was 5.4 +/- 0.3 in the group with releasable sutures compared with 4.2 +/- 0.6 in the group without releasable sutures (P<.001). The mean +/- SD final intraocular pressure at the end of 12 months was 16.9 +/- 1.2 mm Hg in the group without releasable sutures and 15.0 +/- 0.9 mm Hg in the group with releasable sutures (P<.001). Final intraocular pressure was controlled (intraocular pressure < or =21 mm Hg) in all patients in the group with releasable sutures, giving a success rate of 100%, and in 12 patients in the group without releasable sutures, giving a success rate of 80%. CONCLUSIONS: Use of releasable sutures is an effective way at no extra cost or instrumentation to maximize the long-term bleb score and lower intraocular pressure, and to minimize the short-term complications of trabeculectomy.     

Immunoglobulin prophylaxis in shunt infections: a prospective randomized study

Continuous external subdural drainage (CESD) was suggested as a treatment step to be inserted prior to SP shunting, primarily because it makes it possible to avoid shunt placement in a significant number of patients. Thirty-three patients with symptomatic chronic subdural collection confirmed by computed tomography were included in this study. Unilateral CESD was performed in all cases, using a lumbar drainage set. The drains were left in place for no more than 10 days. A subduroperitoneal (SP) shunt was inserted in those patients in whom re-accumulation of the subdural collection had occurred. Of 33 patients, 17 were definitively treated by CESD and 16 subsequently needed an SP shunt. The cost of treatment with CESD was just less than half the cost of treatment with SP shunting. CESD can be used as a step before SP shunting in the management of chronic infantile subdural collections, since it is effective without further treatment in half the patients and safer than subdural tapping.     

A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery

BACKGROUND: Bladder drainage is necessary for several days following rectal surgery. Urethral catheterization has long been known to be associated with significant morbidity. Therefore a prospective randomized trial was performed to determine if this morbidity could be decreased by suprapubic catheterization. METHODS: One hundred and thirty-seven patients undergoing rectal surgery were prospectively randomized to either suprapubic or urethral catheterization. RESULTS: After exclusions, 108 patients were analysed. Of the 49 patients with suprapubic catheters there was 14% morbidity, and of the 59 patients with urethral catheters there was 32% morbidity. Significant bacteriuria was halved with suprapubic catheterization. Patient acceptability of suprapubic catheterization was high, and there was no increased morbidity in any of the areas studied. CONCLUSIONS: This study suggests that suprapubic catheterization has advantages over urethral catheterization with decreased bacteriuria, and greater patient acceptability. However, the significance of decreased bacteriuria is not clear and therefore we can only say suprapubic catheter drainage is comparable to urethral catheter drainage.     

Laparoscopic versus conventional appendectomy: a prospective randomized study

The discussion about laparoscopic appendectomy has increased since the introduction of this method. Randomized comparisons are still feasible, whereas this cannot be stated for other laparoscopic procedures (e.g., laparoscopic cholecystectomy). This randomized controlled trial included 170 patients. Open appendectomy was employed in 83 patients, and 87 were treated laparoscopically. The treatment groups were comparable regarding age, sex, Broca index, ASA classification, preliminary operations, and preoperative leucocytes. No statistically significant differences could be found with respect to surgical and general complications, operating time, consumption of analgesics and antibiotics, and return to work. The analysis revealed a statistically significant shorter hospital stay, a shorter time until return to normal physical activity, and a shorter duration of complaints for the laparoscopic group. We were unable to demonstrate any statistically significant advantage in using the open procedure.     

A randomized prospective controlled trial of oral acyclovir versus oral ganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients

BACKGROUND: Posttransplantation cytomegalovirus (CMV) infection remains a significant cause of morbidity in kidney transplant recipients. We performed a randomized prospective controlled trial of oral acyclovir versus oral ganciclovir for CMV prophylaxis in a group of renal allograft recipients considered at high risk for CMV disease due to the use of OKT3 induction therapy. METHODS: A total of 101 recipients of cadaveric (83) and zero haplotype-matched live donor (18) kidney transplants were entered into the trial. A total of 22 D-R- patients received no prophylaxis. Twenty-seven D+R-, 29 D+R+, and 23 D-R+ patients were randomized to receive 3 months of either oral acyclovir (800 mg q.i.d.) or oral ganciclovir (1000 mg t.i.d.). Doses were adjusted according to the level of renal function. The D+R- patients were also given CMV immune globulin biweekly for 16 weeks. Surveillance blood cultures were obtained at transplantation, at months 1, 2, 3, and 6, and when clinically indicated. The primary study end points were time to CMV infection and disease the first 6 months after transplantation. RESULTS: The mean follow up was 14.4 months. Both agents were well tolerated, and no drug interruptions for toxicity occurred. CMV was isolated in 14 of 39 (35.9%) acyclovir-treated and 1 of 40 (2.5%) ganciclovir-treated recipients by 6 months (P=0.0001). Symptomatic CMV disease occurred in 9 of 14 (64%) of the acyclovir patients, two with tissue-invasive disease. Infection rates for acyclovir vs. ganciclovir, respectively, stratified by CMV serology were: D+R-, 54 vs. 0%, P=0.0008; D+R+, 43 vs. 6.6%, P=0.01; D-R+, 8.3 vs. 0%, P=NS. No patient developed CMV infection while taking oral ganciclovir, however three delayed infections occurred 2-7 months after finishing therapy. Each patient had been previously treated for acute rejection. CONCLUSIONS: Oral acyclovir provides effective CMV prophylaxis only for recipients of seronegative donor kidneys. Oral ganciclovir is a superior agent providing effective CMV prophylaxis for recipients of seropositive donor kidneys. Recipients who are treated for acute rejection are at risk for delayed CMV infection during the first posttransplantation year.     

Impaired liver function tests in patients treated with antithymocyte globulin: implication for liver transplantation

Antithymocyte globulin (ATG) is traditionally used as a conventional immunosuppression agent in various pathological states including severe aplastic anaemia (SAA), graft versus host disease (GVHD), and for the prevention and treatment of graft rejection and GVHD post bone marrow and liver transplantation. We reviewed the liver functions of 16 haematological patients with no previous liver disorders who received ATG as part of their pre-bone marrow transplantation (BMT) conditioning regimen, and the liver function tests of five SAA patients who received ATG as part of their treatment. Liver functions were evaluated at day -1 pre-, and days +3 and +10 post-ATG treatment. All patients had normal liver functions before treatment. In the haematological patients, the mean serum lactic dehydrogenase (LDH) levels increased from 408.7 +/- 37.7 U/l pre-treatment to 1394.4 +/- 488.7 U/l 3 days post-treatment (n = 16; p < 0.029), and then declined to 561.4 +/- 61.3 U/l 10 days post-treatment (n = 16; p < 0.043). The mean alanine aminotransferase (ALT) levels increased from 51.9 +/- 11.3 U to 184.6 +/- 74.6 U (n = 16; p < 0.036), and then declined to 121.9 +/- 61.3 U (n = 16; NS). The mean aspartate amino transferase (AST) levels increased from 31.2 + 5.7 U to 152.0 +/- 67.0 U (n = 16; p < 0.44) and then declined to 46.0 +/- 14 (n = 16; p < 0.049). The mean tau-glutamyltransferase (GTP) levels increased from 93.0 +/- 34 to 188.0 +/- 36 (n = 16; p < 0.02), and were 168.0 +/- 37.0 at day +10 (n = 16; NS). The mean bilirubin levels increased from 18.0 +/- 1.9 microM l(-1) to 22.7 +/- 2.8 (n = 16); NS), at day +3 and to 31.9 +/- 6.9 at day +10 (n = 16; NS). In contrast, no significant changes in liver function tests were demonstrated in the SAA patients treated with ATG. The possible pathophysiologic mechanisms and the clinical implications for liver transplantation are discussed.     

Nutritional support after hepatic resection: a randomized prospective study

BACKGROUND: A consensus as to whether hypertonic dextrose should be given to patients with chronic liver diseases such as cirrhosis or chronic hepatitis after major hepatectomy has not been reached, mostly because metabolism in the remnant liver switches from utilization of blood glucose to utilization predominantly of fatty acid as an energy source. We investigated whether nutritional support would have beneficial effects for such patients. PATIENTS AND METHODS: Among 19 patients, 10 were given peripheral dextrose (10 kcal/kg/day) for seven days following hepatectomy and the other 9 were given hypertonic glucose. Twenty and 30 kcal/kg/day was the average non-protein caloric intake, including free oral intake during the first one week following hepatectomy, respectively. RESULTS: The groups were comparable with regard to laboratory data and operative stress. There were no untoward effects related to this support. In patients given nutritional support, retinol binding protein and prealbumin improved (p < 0.05 and p < 0.05, respectively), urinary 3-methylhistidine excretion decreased (p < 0.01) and the nitrogen balance normalized earlier (p < 0.05), as compared to findings with the conventional method. CONCLUSION: The remnant liver can utilize dextrose and nutritional support improves the nutritional status and may even preserve muscle protein mass.     

Subconjunctival versus peribulbar anesthesia in trabeculectomy: a prospective, randomized study

BACKGROUND AND OBJECTIVE: To compare the use of subconjunctival and peribulbar anesthesia for trabeculectomy. PATIENTS AND METHODS: Sixty patients undergoing trabeculectomy were prospectively randomized to receive either peribulbar or subconjunctival anesthesia. Peribulbar anesthesia consisted of a 3-ml inferior and a 1-ml superior injection of a 1:1 mixture of 2% mepivacaine, 0.75% bupivacaine, and hyaluronidase. Subconjunctival anesthesia consisted of a 1- to 2-ml injection of the same mixture without hyaluronidase in the superotemporal quadrant. Intraoperative pain, presence of eye movements, and complications during surgery were evaluated. RESULTS: The frequency and intensity of pain was statistically similar between the two groups. All episodes of pain (20% in the subconjunctival group and 6.6% in the peribulbar group) were rated as mild. Eye movement was more common in the subconjunctival group than in the peribulbar group, but it was controlled by verbal command and did not interfere with the procedure. No clinically significant complications occurred during surgery. CONCLUSION: Subconjunctival anesthesia is an effective alternative to peribulbar anesthesia for trabeculectomy.     

Lumbar disk prolapse surgery with or without free fat transplantation. A prospective triple-blind randomized study

The aim of this prospective triple-blind randomized study was to determine if a free fat transplant used in operation in lumbar disc herniation could reduce the degree of intraspinal scar tissue and to evaluate whether the scar tissue could lead to symptoms. Ninety-nine patients were subsequently examined after median 376 days. The clinical outcome was scored using the Low Back Pain Rating Scale. Enhanced CT-scanning was assessed regarding the degree of scar tissue and survival of the fat transplant. There was no difference in the clinical outcome between the two groups. Significantly fewer had dural scarring in the group who had a free fat transplantation, but there was no difference regarding the degree of radicular scarring. The transplant was shown on CT-scan at the follow-up examination in 66% of the patients who had a fat transplantation. Free fat transplantation can reduce the degree of dural scar tissue after operation for lumbal disc herniation, but does not result in a clinically better outcome.     

Healing of deep venous thrombosis: venographic findings in a randomized study comparing streptokinase and heparin

Sequential ascending venographic studies were used to assess the healing of deep venous thrombosis in 50 patients randomly assigned to streptokinase or heparin therapy. Various degrees of thrombolysis and/or recanalization were demonstrated by venograms performed on the fourth and tenth days of treatment. Late follow-up studies (mean, 7 months after treatment) showed three basic patterns of resolution: (1) return to normal, (2) complete recanalization, and (3) incomplete recanalization and/or collateralization. Loss of valves or their function was associated with recanalization. The character, speed, and outcome of healing reflected the nature and extent of thrombosis, prior thrombotic disease in the extremity, and the type and timing of treatment. Streptokinase was highly effective and preferable to heparin in patients with deep vein thrombosis when therapy was begun within 4 days of onset of symptoms. In later stages of acute or recurrent deep vein thrombosis, the effectiveness of both drugs was significantly reduced.     

A prospective, randomized trial comparing laparoscopic versus conventional techniques in colorectal cancer surgery: a preliminary report

BACKGROUND: Uncontrolled studies using laparoscopic techniques in colorectal surgery have not demonstrated clear advantages to these procedures compared with conventional ones, and surgeons are concerned about unusual early recurrences reported after laparoscopic colorectal cancer surgery. STUDY DESIGN: We conducted a prospective, randomized trial in one surgical department comparing laparoscopic (LAP) and conventional (CON) techniques in 109 patients undergoing bowel resection for colorectal cancers or polyps. Postoperatively, all patients underwent measurement of pulmonary function tests every 12 hours, and were treated identically on a highly controlled protocol with regard to analgesic administration, feeding, and postoperative care. RESULTS: Of the 55 patients assigned to LAP and 54 to the CON group, there were 42 and 38 with cancer, respectively (the other patients had large adenomas). Overall recovery of 80% of forced expiratory volume in 1 second and forced vital capacity was a median of 3 days for LAP and 6.0 days for CON (p = 0.01). LAP patients used significantly less morphine than CON patients up to the second day after surgery (0.78 +/- 0.32 versus 0.92 +/- 0.34 mg/kg per day, p = 0.02). Flatus returned a median of 3.0 days after LAP versus 4.0 days after CON surgery (p = 0.006). Tumor margins were clear in all patients. After a median followup of 1.5 years (LAP) and 1.7 years (CON), there were no port site recurrences in the LAP group. Seven cancer-related deaths have occurred (three in the LAP group, four in the CON group). CONCLUSIONS: Within this prospective, randomized trial, laparoscopic techniques were as safe as conventional surgical techniques and offered a faster recovery of pulmonary and gastrointestinal function compared with conventional surgery for selected patients undergoing large bowel resection for cancer or polyps. There were no apparent shortterm oncologic disadvantages. Longer followup is needed to fully assess oncologic outcomes.