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Results for “Randomized trial”

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PubMed1995

Transabdominal versus retroperitoneal incision for abdominal aortic surgery: report of a prospective randomized trial.

PURPOSE: The purpose of this study was to perform a randomized, prospective trial that compares the transabdominal with the retroperitoneal approach to the aorta for routine infrarenal aortic reconstruction. METHODS: From August 1990 through November 1993, patients undergoing surgery for abdominal aortic aneurysm (AAA) disease or aortoiliac occlusive disease (AIOD) were asked to participate in a randomized trial comparing the transabdominal incision (TAI) to the retroperitoneal incision (RPI) for aortic surgery. One hundred forty-five patients were randomized, with 75 (41 with AAA and 34 with AIOD) in the TAI group and 70 (40 with AAA and 30 with AIOD) in the RPI group. There were no significant differences between the groups in terms of age, sex, postoperative pain control (epidural vs patient-controlled analgesia), or comorbid conditions, except for a higher incidence of chronic obstructive pulmonary disease in the TAI group (21 vs 8 patients). RESULTS: The incidence of intraoperative complications was similar for both groups. After surgery, the incidence of prolonged ileus (p = 0.013) and small bowel obstruction (p = 0.05) was higher in the TAI group. Overall, the RPI group had significantly fewer complications (p < 0.0001). The overall postoperative mortality rate (two deaths) was 1.4%, with both occurring in the TAI group (p = 0.507). The RPI group also had significantly shorter stays in the intensive care unit (p = 0.006), a trend toward shorter hospitalization (p = 0.10), lower total hospital charges (p = 0.019), and lower total hospital costs (p = 0.017). There was no difference in pulmonary complications (p = 0.71). In long-term follow-up (mean 23 months), the RPI group reported more incisional pain (p = 0.056), but no difference was found in incisional hernias or bulges (p = 0.297). CONCLUSIONS: We conclude that the RPI approach for abdominal aortic surgery is associated with fewer postoperative complications, shorter stays in the hospital and intensive care unit, and lower cost. There is, however, an increase in long-term incisional pain. Current methods of postoperative pain control seem to decrease the incidence of pulmonary complications.

Abdomen↗

PubMed1988

Randomized trial of tamoxifen versus aminoglutethimide and versus combined tamoxifen and aminoglutethimide in advanced postmenopausal breast cancer.

In a randomized trial, 105 postmenopausal women with advanced carcinoma of the breast received tamoxifen or aminoglutethimide or combined tamoxifen and aminoglutethimide. No differences were found in the rate of responses and duration of responses between the treatment groups. Toxicity was significantly greater (p less than 0.01) in patients who received aminoglutethimide.

Adult↗

PubMed1994

The role of luteal phase support in infertility treatment: a meta-analysis of randomized trials.

OBJECTIVE: To determine whether the use of luteal phase support improves pregnancy rate (PR) in infertility. DESIGN: A meta-analysis of randomized trials of luteal phase support. Search of the National Library of Medicine MEDLINE data base from 1971 using the words luteal, pregnancy, human, and comparative. Bibliography of relevant articles, reviews, and abstracts of scientific meetings were hand searched. All randomized controlled trials of luteal phase support in infertility were included. Luteal phase support for recurrent abortion and nonrandomized trials were excluded. The common odds ratio was calculated for each intervention using the Mantel-Haentzel test. Homogeneity of treatment effect was evaluated using the Breslow-Day test. MAIN OUTCOME MEASURES: Pregnancy per cycle, rate of spontaneous abortion, and ovarian hyperstimulation syndrome rate. RESULTS: Eighteen trials met the above criteria. Human chorionic gonadotropin improved PRs in IVF when GnRH agonist (GnRH-a) was used (n = 151) and was superior to P (n = 352). Its benefit in all IVF cycles, however, was not established because of significant heterogeneity of treatment effect. Progesterone improved the PR in all IVF cycles (n = 457). No significant reduction in spontaneous abortion was noted with luteal support (n = 200). Ovarian hyperstimulation syndrome occurred in 5% of patients with hCG. Combination of data from trials of luteal support with other infertility therapies was not possible because of the differences in patient populations. CONCLUSIONS: The meta-analysis supports the routine use of hCG in IVF cycles using a GnRH-a. Progesterone was also beneficial for luteal phase support in IVF. For other infertility therapy, however, further research is needed to evaluate the role of luteal phase support.

Abortion, Spontaneous↗

PubMed1975

Randomized trial of albumin vs. electrolyte solutions during abdominal aortic operations.

In a prospective randomized trial of 16 patients undergoing abdominal vascular reconstructive procedures, changes in plasma volume, serum oncotic pressure (pis), serum albumin and total protein concentration, alveolar to arterial oxygen tension differences (AaDO2, FIO2 = 1.0), creatinine clearance, body weight, and fluid and sodium intake were examined. By random assignment patients received either an albumin- or a sodium-rich intraoperative fluid regimen. Pulmonary arteriovenous admixture was significantly less in the albumin group (n = 7) than in the electrolyte group (n = 9) on the first postoperative day. The change in AaDO2 correlated positively with the total sodium intake in the electrolyte group. Despite the larger fluid load and significantly greater gain of body weight, patients in the electrolyte group had a postoperative plasma volume significantly lower than the preoperative value. Postoperative values of albumin concentration, circulating albumin mass and pis were significantly greater in the albumin group in comparison to the electrolyte group. Creatinine clearance values were not different between the two groups. The change in pis correlated significantly with sodium intake and circulating albumin mass. Pulmonary shunting and expansion of the extracellular fluid volume may be minimized without adverse effects on renal function by administration of fluids rich in albumin in preference to sodium.

Aged↗

PubMed2026

Accelerated Diagnostic Pathways for Suspected Acute Coronary Syndrome in Practice: A Randomized Trial of 0/1-Hour vs 0/3-Hour Troponin Testing.

BACKGROUND: For suspected acute coronary syndrome (ACS), guidelines recommend using high-sensitivity troponins (hs-cTn) in accelerated diagnostic pathways (ADPs) with 0/1-hour recommended over 0/3-hour ADP. However, implementation of these ADPs, with universal use of hs-cTns, has not been directly compared in randomized trials OBJECTIVES: This study sought to compare the efficiency and safety of the European Society of Cardiology (ESC) 0/1-hour and a 0/3-hour ADP when implemented in real-world clinical practice. METHODS: This pragmatic, randomized, noninferiority implementation trial compared the safety and efficiency of clinician decision making using these 2 pathways. To prevent incorporation bias, an independent hs-cTnI was used for formal adjudication using the fourth universal definition of myocardial infarction (MI). Efficiency was judged by the proportion of patients discharged within 4 hours. The safety endpoint was major adverse cardiac events (MACE) within 30 days (adjudicated index or representation type 1 MI, cardiovascular death, and urgent coronary revascularization) for those who were considered not to have ACS and discharged. The noninferiority margin, for absolute difference in sensitivity, between the ESC 0/1-hour and the 0/3-hour ADP was set at 3%, assessed with a 1-sided 97.5% CI. RESULTS: From December 2021 to July 2024, of 13,983 screened 3,543 individual patients with suspected ACS were recruited and consented from 2 major emergency departments in North-West England, with 100% follow-up achieved for all representations to any national hospital. The median age was 60 years (IQR: 49.5-70.5 years), 53% were men, 6.7%, and 7.6% had adjudicated index type 1 MI and MACE within 30 days, respectively. The turnaround time from sample to result for central laboratory hs-cTnT was 81 minutes (IQR: 69-101 minutes). The proportion of patients discharged within 4 hours was relatively low and did not differ substantially (21.8% vs 19.2%, P = 0.07). In addition, the 0/1-hour pathway was noninferior for safety, in patients discharged, compared with the 0/3-hour pathway, absolute difference in sensitivity was +4.2% (1-sided 97.5% CI: -2.5) in favor of the 0/1-hour pathway. The calculated sensitivities were 93.7% (95% CI: 88.4%-97.1%) vs 89.5% (95% CI: 82.7%-94.3%), respectively. CONCLUSIONS: Implementation of the ESC 0/1-hour pathway failed to discharge significantly more patients within 4 hours of presentation compared with the 0/3-hour ADP. In addition, The ESC 0/1-hour was noninferior to the 0/3-hour hs-cTn pathway for safety of discharge, although safety for both pathways was less than that imputed by observational studies. This trial demonstrates that perceived benefits to emergency department efficiency of a reduced sampling interval are mitigated by central laboratory turnaround times as well as system constraints. (Pragmatic Randomised Trial of the ESC 0/1 Versus 0/3 Hour Troponin Pathway [MACROS2]; NCT05322395).

Acute Coronary Syndrome↗

PubMed1999

Influence of estrogen-progestin treatment on back pain and disability among slim premenopausal women with low lumbar spine bone mineral density. A 2-year placebo-controlled randomized trial.

STUDY DESIGN: A 2-year randomized controlled trial. OBJECTIVES: To examine the possible preventive or aggravating effect of estrogen-progestin treatment on the back symptoms of slim premenopausal women with low lumbar spine bone mineral density. SUMMARY OF BACKGROUND DATA: The incidence of back pain, sciatica, or both starts to increase clearly among 45-54-year-old Finnish women. METHODS: Forty-eight 39- to 49-year-old premenopausal women with a body mass index of 21 or less and a lumbar spine bone mineral density (L2-L4) of 1.1 +/- 1 g/cm3 or less compared with the normative population were recruited into the study. The women were assigned randomly to receive either estradiol-noretisteron acetate treatment or placebo. Back pain, symptoms, and disability were assessed with the Million and Oswestry questionnaires and pain drawings during the follow-up period at 0, 12, and 24 months. Inquiry also was made concerning previous back pain and sciatica history. RESULTS: There was a statistically significant decrease in nighttime back pain (P < 0.001) and the total Oswestry disability scores (P < 0.004) in the hormone-treated group compared with the control group during the follow-up, but no statistically significant differences were found in daytime back pain. At baseline, the cumulative incidence in a history of pain radiating from the buttock to the foot in this osteopenic study group was 31/48, (64.5%; 95% CI 50.5-78.6), which is much more than the predicted 20/48, (42.4%; 95% CI 39.0-45.7) at this age according to a previous population study. The cumulative incidence of at least one back pain episode 44/48, (91.7%; 95% CI 83.6-99.8) was somewhat higher in these participants than was predicted for a comparative population of women this age, 38/48 (79.2%; 95% CI 70.2-87.3). CONCLUSIONS: It seems that this regimen may have alleviating effects on nighttime back pain and functional back disability in slim osteopenic premenopausal women.

Adult↗

PubMed1995

Tubal versus uterine transfer of cryopreserved embryos: a prospective randomized trial.

OBJECTIVE: To compare pregnancy rates after fallopian tubal and uterine transfer of cryopreserved embryos. DESIGN: Prospective randomized trial with assignment to treatment groups by a random number table. SETTING: University of Iowa Hospitals and Clinics, a tertiary care academic institution. PATIENTS: Forty patients with patent fallopian tubes and at least three cryopreserved embryos. INTERVENTIONS: Cryopreserved embryos were thawed and transferred to the fallopian tube by laparoscopy or to the uterus by a transcervical catheter. MAIN OUTCOME MEASURES: Clinical and ongoing pregnancy rates. RESULTS: Tubal transfer of cryopreserved embryos resulted in statistically higher clinical (68% versus 24%) and ongoing pregnancy rates (58% versus 19%) when compared with uterine transfer. CONCLUSIONS: Tubal transfer of cryopreserved embryos is highly effective and offers an improved pregnancy rate when compared with uterine transfer of embryos. This method of transfer should be considered in patients with patent fallopian tubes and at least three cryopreserved embryos.

Adult↗

PubMed1995

Oral granisetron with or without methylprednisolone versus metoclopramide plus methylprednisolone in the management of delayed nausea and vomiting induced by cisplatin-based chemotherapy. A prospective randomized trial.

BACKGROUND: A single-institution, randomized open trial was prospectively performed to compare orally administered granisetron with or without intramuscularly administered methylprednisolone to metoclopramide plus methylprednisolone in the prevention of delayed nausea and vomiting induced by cisplatin-based chemotherapy. The effects of antiemetic treatments were evaluated from days 2 to 5 of the first cycle after cisplatin administration among patients who had never before received chemotherapy. METHODS: All patients were treated with chemotherapeutic regimens containing cisplatin greater than or equal to 80 mg/m2 and received antiemetic therapy with granisetron 3 mg intravenously for the control of acute emesis. Patients who responded to treatment during the first 24 hours were randomized to receive (1) metoclopramide (0.5 mg/kg) intramuscularly three times daily plus methylprednisolone (125 mg) intramuscularly once a day or (2) granisetron (1 mg) orally twice daily or (3) oral granisetron (1 mg) orally plus methylprednisolone (125 mg) intramuscularly from days 2 to 5. RESULTS: Of the patients treated with metoclopramide plus methylprednisolone (n = 92), 53% had complete protection from delayed emesis, 16% a major response, 15% a minor response, and 15% no response. Of the patients treated with granisetron alone (n = 84), 33% had a complete response, 21% a major response, 23% a minor response, and 21% no response. In the patients treated with orally administered granisetron plus intramuscularly administered methylprednisolone (n = 86), 47% had a complete response, 17% a major response, 23% a minor response, and 13% no response. These differences reached statistical significance only when the complete response rate achieved in the metoclopramide plus methylprednisolone group was compared with that recorded in the oral granisetron group (P = 0.012). Moreover, the metoclopramide plus methylprednisolone and the orally administered granisetron plus corticosteroid arms were superior to the orally administered granisetron alone arm in preventing nausea (P < 0.038 and P < 0.002, respectively). No extrapyramidal side effects were noted for the granisetron alone and the granisetron plus methylprednisolone arms, whereas 6% of patients treated with metoclopramide had extrapyramidal adverse effects. Headache was recorded in 8% of patients treated with granisetron alone, in 9% treated with granisetron plus methylprednisolone, and in 3% treated with metoclopramide plus methylprednisolone. CONCLUSIONS: These data suggest that orally administered granisetron with or without methylprednisolone may be given safely to patients with cancer as prophylactic therapy against delayed emesis after high dose cisplatin therapy. Orally administered granisetron alone was less active than a standard combination of metoclopramide plus methylprednisolone. However, the addition of corticosteroid to orally administered granisetron improved the control of delayed emesis. The efficacy of the combination of metoclopramide plus methylprednisolone and oral granisetron with or without methylprednisolone against delayed emesis still is not entirely satisfactory.

Administration, Oral↗

PubMed1996

Antioxidants in cardiovascular disease: randomized trials.

The hypothesis that antioxidant vitamins might reduce cardiovascular disease risk is based on a large body of both basic and human epidemiologic research. One of the most consistent findings in dietary research is that those who consume higher amounts of fruits and vegetables have lower rates of heart disease and stroke as well as cancer. Recent attention has focused on the antioxidant content of fruits and vegetables as a possible explanation for the apparent protective effects. Basic research provides a plausible mechanism by which antioxidants might reduce the risk of atherosclerosis. A large number of descriptive, case-control and cohort studies provide data suggesting that consumption of antioxidant vitamins is associated with reduced risks of cardiovascular disease. These data raise the question of a possible role of antioxidants, such as vitamins C and E, and beta carotene, in the primary prevention of cardiovascular disease but do not provide a definitive answer. Results from several large-scale randomized trials of antioxidant supplements are now available; however, results are not entirely consistent. The results of the major trials do not prove or disprove the value of antioxidant vitamins, nor do they incriminate them as harmful. They do, however, raise the possibility that some of the benefits from observational epidemiology may have been overestimated and that there may be some adverse effects. At this point randomized trial data are not yet sufficient to fully assess the risk-to-benefit ratios for antioxidant supplements. More reliable data should be forthcoming in the near future which will better define the role of antioxidants in the primary and secondary prevention of atherosclerotic disease as well as cancer.

Antioxidants↗

PubMed1977

Combination chemotherapy in advanced breast cancer.: a randomized trial comparing a three-vs a five-drug program.

A prospective randomized trial was undertaken to compare the efficacy of a three-drug regimen using cyclophosphamide, methotrexate, and fluorouracil to a five-drug regimen using vincristine sulfate and prednisone in addition to cyclophosphamide, methotrexate, and fluorouracil in advanced breast carcinoma. Seventy-two patients who had received no prior chemotherapy were randomized. Thirty-eight patients received three drugs, and 34 received five-drug therapy. The objective response rates, 34% and 50% respectively, did not differ signficantly (P = .13). As expected, myelosuppression occurred in most patients, and neurotoxicity was much more common in patients receiving vincristine. Three of 12 patients treated with the five-drug regimen after progession of disease while receiving the three-drug regiment showed an objective response to the five-drug regimen.

Breast Neoplasms↗

PubMed1990

Albumin supplementation in the critically ill. A prospective, randomized trial.

Albumin replacement to correct hypoalbuminemia in critically ill patients has been controversial. This study was a prospective, randomized trial of 25% albumin administration in 40 hypoalbuminemic (serum albumin, less than 25 g/L [2.5 g/dL]), critically ill patients. The treatment group (18 patients) received 25% albumin supplementation to achieve and maintain serum albumin levels of 25 g/L (2.5 g/dL) or greater, while the nontreatment group (22 patients) received no concentrated albumin. There was no clinical benefit from albumin therapy when assessing mortality (39% vs 27%, treatment vs control) or major complication rate (89% vs 77% of patients). There were also no significant differences in length of hospital stay, intensive care unit stay, ventilator dependence, or tolerance of enteral feeding, despite significant elevations of albumin in the treatment group. The costly use of exogenous albumin as treatment for hypoalbuminemia in this patient population does not appear to be justified.

Aged↗

PubMed2006

What to think if the results of the National Institutes of Health randomized trial of methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus control measures are negative (and other advice to young epidemiologists): a review and an au revoir.

The incidence of methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) infections continues to rise in National Nosocomial Infections Surveillance system hospitals, and these pathogens are reportedly causing more than 100,000 infections and many deaths each year in US healthcare facilities. This has led some to insist that control measures are now urgently needed, but several recent articles have suggested that isolation of patients does not work, is not needed, or is unsafe, or that a single cluster-randomized trial could be used to decide such matters. At least 101 studies have reported controlling MRSA infection and 38 have reported controlling VRE infection by means of active detection by surveillance culture and use of isolation for all colonized patients in healthcare settings where the pathogens are epidemic or endemic, in academic and nonacademic hospitals, and in acute care, intensive care, and long-term care settings. MRSA colonization and infection have been controlled to exceedingly low levels in multiple nations and in the state of Western Australia for decades by use of active detection and isolation. Studies suggesting problems with using such data to control MRSA colonization and infection have their own problems, which are discussed. Randomized trials are epidemiologic tools that can sometimes provide erroneous results, and they have not been considered necessary for studying isolation before it is used to control other important infections, such as tuberculosis, smallpox, and severe acute respiratory syndrome. No single epidemiologic study should be considered definitive. One should always weigh all available evidence. Infection with antibiotic-resistant pathogens such as MRSA and VRE is controllable to a low level by active detection and isolation of colonized and infected patients. Effective measures should be used to minimize the morbidity and mortality attributable to these largely preventable infections.

Cross Infection↗

PubMed2002

Combination chemotherapy with or without s.c. IL-2 and IFN-alpha: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM).

The purpose of this randomized trial was to evaluate the efficacy of combination chemoimmunotherapy compared with chemotherapy alone. A total of 124 patients were randomized to receive intravenous cisplatin (35 mg m(-2), days 1-3), carmustine (150 mg m(-2), day 1, cycles 1 and 3 only), dacarbacine (220 mg m(-2), days 1-3) and oral tamoxifen (20 mg m(-2), daily) in combination with (n=64) or without (n=60) sequential subcutaneous IL-2 and IFN-alpha. In those patients who received sequential immunotherapy, each cycle of chemotherapy was followed by outpatient s.c. IL-2 (10 x 10(6) IU m(-2), days 3-5, week 4; 5 x 10(6) IU m(-2), days 1, 3, 5, week 5) and s.c. IFN-alpha (5 x 10(6) IU m(-2), day 1, week 4; days 1, 3, 5, week 5). The overall response rate of patients treated with the combination of chemotherapy and IL-2/IFN-alpha was 34.3% with seven complete responses (10.9%) and 15 partial responses (23.4%). In patients treated with chemotherapy, only, the overall response rate was 29.9% with eight complete responses (13.3%) and 10 partial responses (16.6%). There was no significant difference in median progression free survival (0 months vs 4 months) and in median overall survival (12 months vs 13 months) for combined chemoimmunotherapy and for chemotherapy, respectively.

Administration, Oral↗

PubMed2006

The use of bisphosphonates in men with hormone-refractory prostate cancer: a systematic review of randomized trials.

PURPOSE: A systematic review of randomized controlled trials (RCTs) was performed to assess the benefits of bisphosphonate therapy in men with hormone-refractory prostate cancer (HRPC). METHODS: The literature was searched to identify RCTs or meta-analyses comparing treatment with bisphosphonates to placebo or no treatment. RESULTS: Ten trials that studied clodronate (five trials, 404 patients), pamidronate (two trials, 350 patients), alendronate (one trial, 49 patients), etidronate (one trial, 51 patients), and zoledronic acid (one trial, 643 patients) in men with HRPC and bone metastases met the eligibility criteria. Pain response was the most frequently reported primary outcome (eight trials). Only the smallest trial demonstrated a statistically significant improvement in pain, but other non-statistically significant trends and subgroup analyses showing improvement in pain were observed in six clodronate and pamidronate trials. Three trials reported skeletal-related events (SREs). A trial studying zoledronic acid reported a statistically and clinically significant reduction in the number of patients having at least one SRE; however, there were higher rates of some adverse effects, and quality of life was not improved. CONCLUSION: Zoledronic acid appears to reduce the number of patients having at least one SRE in men with bone metastases from HRPC that are causing minimal or no pain. This benefit should be weighed against the associated toxicities, and the neutral effect on quality of life. Bisphosphonates may reduce bone pain in men with HRPC, but the evidence is less robust. Further investigations to identify the role of bisphosphonates alone and in combination with other therapies proven effective for men with HRPC are warranted.

Diphosphonates↗

PubMed1981

[Disseminated breast carcinoma. Study of activity of immunotherapy with BCG and duration of the phase of intensive chemotherapy. Results of a randomized trial (author's transl)].

144 patients with disseminated breast cancer entered into a 4 arm randomized trial. They received a chemotherapy protocol combining monthly administration of adriamycin (40 mg/m2 on day 1), vincristine (1,2 mg/m2 of day 2), cyclophosphamide (400 mg/m2 on days 3, 4, 5), 5 fluorouracil (500 mg/m2 on days 3, 4, 5). Patients in groups I and III were given 6 courses at monthly intervals and patients in groups II and IV were given 10 courses. Then they were given indefinitely a monthly course of cyclophosphamide (100 mg/m2/day for 7 days), melphalan (2,5 mg/m2/day for 7 days), methotrexate (25 mg/m2/week for 3 weeks). Patients in groups III and IV were given 3 applications of living BCG disposed on a scratched area between courses of chemotherapy. The overall response rate was 73 per cent (105/144) and was comparable in each treatment group. The mean duration of response and the mean survival times were comparable in each treatment group. The mean duration of response and the mean survival times were comparable in the 4 treatment arms. The initial tumor mass, serial levels of CEA and skin responses to recall antigens were of prognostic significance. Age, hormonal status, initial lymphocytes count had no prognostic significance.

Adult↗

PubMed2003

Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial.

PURPOSE: To describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions. MATERIALS AND METHODS: Twenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months. RESULTS: Technical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87% of patients (13 of 15) in the endoprosthesis group versus 46% of patients (six of 13) in the PTA group. CONCLUSION: This single-center experience with placement of the Hemobahn endoprosthesis (W.L. Gore & Associates) in the SFA demonstrated a statistically significant improvement in both patency and clinical outcome compared with PTA alone.

Aged↗

PubMed1992

Prospective, randomized trial of inpatient vs. outpatient bowel preparation for elective colorectal surgery.

A prospective, randomized trial of inpatient vs. outpatient bowel preparation for elective colorectal surgery was performed in 100 consecutive patients. Bowel preparation was standardized for both groups and consisted of 4 liters of Colyte (Reed & Carnrick, Piscataway, NJ) and oral neomycin and Flagyl (G. D. Searle & Co., Skokie, IL) the day before surgery. Patients were randomized into four subcategories: ileocolostomy, colocolostomy, abdominal perineal resection, and other. Tap water enemas were administered on the morning of surgery to ensure and adequate mechanical preparation. Ninety-six percent of the inpatient group and 97 percent of the outpatient group were able to drink three-fourths or more of the oral lavage preparation (P = 0.789, Fisher's exact text). A mean of 2.26 tap water enemas was required to achieve clear returns for the inpatient group, compared with 2.28 tap water enemas for the outpatient group (P = 0.221, Fisher's exact test). The adequacy of the bowel preparation as graded by the primary surgeon was good (84 percent), fair (12 percent), and poor (4 percent) in the outpatient group (P = 0.673, Fisher's exact test). Wound infection developed in 4 percent of the inpatient group and 4 percent of the outpatient group (P = 1.0, Fisher's exact test). Anastomotic leak of intra-abdominal abscess was seen in one patient in each group (P = 1.0, Fisher's exact test). We conclude that outpatient bowel preparation is as effective as inpatient bowel preparation for elective colorectal surgery and offers the advantage of cost savings and shorter hospitalization.

Adult↗

PubMed1981

A randomized trial to compare rubber band ligation with phenol injection for treatment of haemorrhoids.

A prospective randomized trial has compared rubber band ligation with phenol injection in 82 patients with symptomatic haemorrhoids. The symptomatic results in all patients 12 months after treatment were indistinguishable, 64 per cent being improved after rubber band ligation, compared with 70 per cent after injection. Complications of treatment were recorded in 5 patients after rubber band ligation, 3 of whom required hospital admission compared with one minor complication after infection. However, repeated treatment was necessary in 13 patients after phenol injection compared with only 4 following rubber band ligation (P less than 0.05). Additional treatment was necessary in 6 patients from each group. Two-thirds of patients with third-degree piles required additional therapy. It is concluded that rubber band ligation and injection provide similar results, but rubber band ligation is more liable to complications with inexperienced operators.

Female↗