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Results for “Randomized trial”

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At least 991 records · Page 55Linked to original sources

PubMed2002

The effects of cash and lottery incentives on mailed surveys to physicians: a randomized trial.

Low response rates, especially among physicians, are a common problem in mailed survey research. We conducted a randomized trial to examine the effects of cash and lottery incentives on response rates. A total of 4,850 subjects were randomized to one of three interventions accompanying a mailed survey-no incentive (n = 1,700), cash payment [three levels of Hong Kong dollars (HKD) $10, $20, and $40; N = 50 in each subgroup], or entry into a lottery (three levels of HKD$1,000, $2,000, and $4,000; N = 1,000 in each subgroup) on receipt of the completed questionnaire. The response rates were higher among those offered incentives than those without (19.8% vs. 16.8%, P =.012). Cash was the more effective incentive compared to lottery (27.3% vs. 19.4%, P =.017). Response also increased substantially between the first and second mailings (14.2% vs. 18.8%, P >.001). In addition, those with specialist qualifications were more willing to participate in mailed surveys. We found no significant differences in response outcomes among the various incentive arms. Cash reward at the $20 level was the most cost-effective intervention, in terms of cost per responder. Further systematic examination of the effects of different incentive strategies in epidemiologic studies should be encouraged.

Adult↗

PubMed1984

Antacid versus sucralfate in preventing acute gastrointestinal bleeding. A randomized trial in 100 critically ill patients.

A randomized, controlled trial of sucralfate versus antacid as prophylaxis against upper gastrointestinal bleeding was carried out in 100 critically ill intensive care unit patients. Both groups were comparable with regard to sex, age, duration of prophylaxis, and the number of risk factors per patient. There was no gross bleeding in any of the patients. Three of the 48 sucralfate patients and 2 of the 52 antacid patients showed strongly positive results of Gastroccult tests of three successive hourly samples of gastric aspirate and were considered treatment failures. We conclude that sucralfate therapy is as effective as an antacid regimen in the prevention of gastrointestinal bleeding in critically ill patients. In view of a considerable savings in nursing time, it offers the opportunity for considerable reduction in the cost of intensive care while providing effective protection.

Aluminum↗

PubMed1986

Sclerotherapy for bleeding esophageal varices after randomized trials.

Endoscopic sclerotherapy remains an uncertain therapy for bleeding esophageal varices. Several recently reported randomized trials address the efficacy of immediate, long-term and prophylactic sclerotherapy. Analysis of these studies suggests that sclerotherapy may stop acute bleeding but has little impact on survival of an acute bleeding episode. Ongoing sclerosis reduces the incidence of rebleeding episodes and improves survival for those patients fortunate enough to survive the acute bleeding episode. Prophylactic therapy is an exciting concept limited by difficulty in identifying "high-risk" patients and by the high rate of complications associated with sclerotherapy.

Clinical Trials as Topic↗

PubMed1988

A prospectively randomized trial of heat probe thermocoagulation versus pure alcohol injection in nonvariceal peptic ulcer hemorrhage.

We conducted a prospectively randomized trial of 78 patients with peptic ulcer hemorrhage to evaluate the hemostatic effects of heat probe thermocoagulation and pure alcohol injection. The initial and ultimate success rates of heat probe thermocoagulation were better than those of pure alcohol injection (p less than 0.05). Rebleeding rates and success rates of retreatment in the two groups were not significantly different. In the case of a spurter or a bleeder located over the lesser curvature side of the stomach or superior wall of the duodenal bulb, heat probe thermocoagulation was better than pure alcohol injection in achieving hemostasis. We conclude that heat probe thermocoagulation is better than pure alcohol injection in arresting peptic ulcer hemorrhage. If the bleeder is a spurter or is located over the lesser curvature side of the stomach or superior wall of the duodenal bulb, heat probe thermocoagulation is the treatment of choice.

Adult↗

PubMed1983

A randomized trial of cadexomer iodine in decubitus ulcers.

Thirty-four patients with decubitus ulcers were studied in a randomized trial to compare topical cadexomer iodine with the standard decubitus ulcer treatments used in the participating hospitals. There was a significant reduction of ulcer area with both treatments within three weeks; however, eight of 16 patients treated with cadexomer iodine had a reduction of ulcer area of more than 50 per cent, compared with one of 18 patients treated with the standard treatment (P less than 0.01). Twenty-seven patients continued the same treatment for five more weeks, during which time six in the cadexomer iodine group healed, compared with one in the standard treatment group (P less than 0.05). Cadexomer iodine was superior to the standard treatment in removing pus and debris from the ulcer surface and in reducing pain at the ulcer site. It was found to be easy both to apply and to remove from the ulcers and did not stain skin or clothing. Transient smarting during the first hour after application was reported by three patients, and one patient complained of skin irritation. The results show that cadexomer iodine applied daily has a debriding effect on decubitus ulcers and accelerates healing.

Administration, Topical↗

PubMed1982

Follow-up of a randomized trial for oat cell carcinoma evaluating the efficacy of peripheral intravenous nutrition (PIVN) as adjunct treatment.

A randomized trial was initiated to compare the effects of peripheral i.v. nutrition (PIVN)-associated chemotherapy (adriamycin, vincristine, VP-16-213, and cyclophosphamide) versus a chemotherapy control group in patients with oat cell lung carcinoma. Thirty-nine evaluable patients were randomized. The test group included 19 patients, whereas 20 were followed in the control group. PIVN was scheduled each day the patient underwent chemotherapy. Each patient received 1,550 kcal day which included 10% glucose, 20% lipids, and amino acids which may or may not have been mixed in the same infusion bottle. The results show ten PIVN patients presently in complete remission at the end of three courses of treatment, compared to nine over the same time period in the chemotherapy control group. Thirty-three percent of patients are still alive after 15 months after the beginning of treatment. There was no significant difference in either general health or side effects, frequency or duration of complete remission, or survival time. After 1 year of treatment, 8 of 19 PIVN patients are still in complete remission, compared to 7 of 20 patients in the control groups.

Carcinoma, Small Cell↗

PubMed1999

Doctors' participation in randomized trials of adjuvant systemic therapy in breast cancer: how does it relate to their recommendations for standard therapy in breast cancer?

A cross-sectional survey of all medical and radiation oncologists in Australia was undertaken, plus surgeons listed as participants of the ANZ Breast Cancer Trials Group, to examine whether doctors' participation in randomized trials of adjuvant systemic therapy for breast cancer, is associated with their recommendations for adjuvant therapy in two clinical scenarios. Two-hundred and sixty-nine questionnaires were returned (response rate 71%). Fifty-six per cent of respondents, were participating in current adjuvant systemic therapy trials. Radiation oncologists were significantly more likely than surgeons or medical oncologists to recommend radiotherapy, while medical oncologists and surgeons were significantly more likely than radiation oncologists to recommend chemotherapy, in both clinical scenarios. In a multivariate analysis adjusting for the differences between specialist groups, respondents recommending chemotherapy were more likely to be high accruers to clinical trials (OR 3.6, 95% CI 0.93 to 13.9, P=0.08) in scenario 1, or participants of a breast cancer trials organization (OR 3.1, 95% CI 1.6 to 5.9, P=0.001) in scenario 2. Some of the variation in adjuvant systemic therapy recommendations is associated with participation in adjuvant systemic therapy trials. However, this study is unable to determine if trial participation influences opinions about adjuvant therapy, or opinions influence trial participation.

Journal Article↗

PubMedDate not supplied

Hyperthermia as an adjuvant to radiation therapy of recurrent or metastatic malignant melanoma. A multicentre randomized trial by the European Society for Hyperthermic Oncology.

The ESHO protocol 3-85 is a multicentre randomized trial investigating the value of hyperthermia as an adjuvant to radiotherapy in treatment of malignant melanoma. A total of 134 metastatic of recurrent malignant melanoma lesions in 70 patients were randomized to receive radiotherapy alone (3 fractions in 8 days) or each fraction followed by hyperthermia (aimed for 43 degrees C for 60 min). Radiation was given with high voltage photons or electrons. Tumours were stratified according to institution and size (above or below 4 cm) and randomly assigned to a total radiation dose of either 24 or 27 Gy to be given with or without hyperthermia. The endpoint was persistent complete response in the treated area. A number of 128 tumours in 68 patients were evaluable, with an observation time between 3 and 72 months. Sixty-five tumours were randomized to radiation alone and 63 to radiation + heat. Sixty received 24 Gy and 68 tumours received 27 Gy, respectively. Size was < or = 4 cm in 81 and > 4 cm in 47 tumours. Overall the 2-year actuarial local tumour control was 37%. Univariate analysis showed prognostic influence of hyperthermia (rad alone 28% versus rad + heat 46%, p = 0.008) and radiation dose (24 Gy 25% versus 27 Gy 56%, p = 0.02), but not of tumour size (small 42% versus large 29%, p = 0.21). A Cox multivariate regression analysis showed the most important prognostic parameters to be: hyperthermia (odds ratio: 1.73 (1.07-2.78), p = 0.02), tumour size (odds ratio: 0.91 (0.85-0.99), p = 0.05) and radiation dose (odds ratio: 1.17 (1.01-1.36), p = 0.05). Analysis of the heating quality showed a significant relationship between the extent of heating and local tumour response. Addition of heat did not significantly increase the acute or late radiation reactions. The overall 5-year survival rate of the patients was 19%, but 38% in patients if all known disease was controlled, compared to 8% in the patients with persistent active disease.

Adult↗

PubMed1997

The relation between nutrition and nosocomial pneumonia: randomized trials in critically ill patients.

OBJECTIVE: To review the effect of enteral nutrition on nosocomial pneumonia in critically ill patients as summarized in randomized clinical trials. STUDY IDENTIFICATION AND SELECTION: Studies were identified through MEDLINE, SCISEARCH, EMBASE, the Cochrane Library, bibliographies of primary and review articles, and personal files. Through duplicate independent review, we selected randomized trials evaluating approaches to nutrition and their relation to nosocomial pneumonia. DATA ABSTRACTION: In duplicate, independently, we abstracted key data on the design features, population, intervention and outcomes of the studies. RESULTS: We identified four trials of enteral vs total parenteral nutrition, one trial of early enteral nutrition vs delayed enteral nutrition, one trial of gastric vs jejunal tube feeding, one trial of intermittent vs continuous enteral feeding, and three trials evaluating different enteral feeding formulae. Sample sizes were small, pneumonia definitions were variable and blinded outcome assessment was infrequent. Randomized trial evidence is insufficient to draw conclusions about the relation between enteral nutrition and nosocomial pneumonia. CONCLUSIONS: Nutritional interventions in critically ill patients appear to have a modest and inconsistent effect on nosocomial pneumonia. This body of evidence neither supports nor refutes the gastropulmonary route of infection.

Journal Article↗

PubMed1987

Single course versus maintenance bacillus Calmette-Guerin therapy for superficial bladder tumors: a prospective, randomized trial.

A total of 42 patients with recurrent superficial bladder tumors or carcinoma in situ entered a prospective, randomized trial to compare the efficacy of bacillus Calmette-Guerin therapy with and without quarterly maintenance instillations of bacillus Calmette-Guerin. Maintenance therapy did not reduce further bladder tumor recurrence rates or the interval to recurrence in patients who responded to the initial course of therapy. However, prolongation of toxicity was observed with maintenance bacillus Calmette-Guerin therapy.

Administration, Intravesical↗

PubMed2001

A randomized trial of a brief intervention to increase fruit and vegetable intake: a replication study among callers to the CIS.

BACKGROUND: Results are reported from a large randomized trial designed to increase fruit and vegetable consumption among callers to the National Cancer Institute's Cancer Information Service (CIS) (n = 1,717). METHODS: CIS callers assigned to the intervention group (n = 861) received a brief proactive educational intervention over the telephone at the end of usual service, with two follow-up mailouts. Key educational messages and print material derived from the NCI 5 A Day for Better Health program were provided to intervention participants. Participants were interviewed by telephone at 4 weeks (n = 1,307), 4 months (n = 1,180), and 12 months for follow-up (n = 1,016). RESULTS: Results obtained from a single-item measure of fruit and vegetable consumption indicate a significant intervention effect of 0.88 servings per day at 4 weeks follow-up (P < 0.001), 0.63 servings per day at 4 months follow-up (P < 0.001), and 0.43 servings per day at 12 months follow-up (P < 0.001). Using a 7-item food frequency measure, an intervention effect of 0.63 servings per day was obtained at 4 weeks follow-up (P < 0.001), compared with 0.39 servings per day at 4 months follow-up (P = 0.002) and 0.44 servings per day at 12 months follow-up (P = 0.002). A 24-h recall assessment included in the 4-month interviews also yielded a significant intervention effect of 0.67 servings per day (P = 0.015). The vast majority of callers (90%) endorsed the strategy of providing 5 A Day information proactively within the CIS. CONCLUSIONS: This brief educational intervention was associated with higher levels of self-reported fruit and vegetable intake at both short- and long-term follow-up. Additional research is recommended to test this or a similar intervention in diverse populations.

Adult↗

PubMed2003

A randomized trial comparing intravesical instillations of mitoxantrone and doxorubicin in patients with superficial bladder cancer.

BACKGROUND: This randomized trial was conducted to compare the efficacy and side effects of intravesical mitoxantrone instillation with those of doxorubicin in superficial bladder cancer following transurethral resection. METHODS: Sixty-three patients were randomized into mitoxantrone and doxorubicin groups. Most of the patients enrolled were elderly people (mean age, 71 years). The instilled doses of doxorubicin and mitoxantrone were 30 and 14 mg, respectively. Disease recurrence and side effects were compared using Fisher's exact test. The interval to recurrence was shown by Kaplan-Meier survivorship curves, and the log-rank test was used to compare the time to recurrence. RESULTS: The median follow-up period was 36 months. Thirty-three patients received mitoxantrone, whereas 30 patients used doxorubicin. The recurrence rate in the doxorubicin group was 30% (95% CI: 19.8%-38.8%), while it was 27.3% (95% CI: 17.5%-36.8%) in the mitoxantrone group. The median recurrence-free survival in the mitoxantrone group and in the doxorubicin group was 22 and 20 months, respectively (p=0.580). Higher recurrence rates were found for Grade III and multiple primary tumors. There was no significant difference in response rates (p=0.784). The incidence of side effects was 20% in the doxorubicin group and 21.2% in the mitoxantrone group. However, the difference was not significant (p>0.99). CONCLUSIONS: The results revealed that the efficacy and side effects of mitoxantrone were similar to those of doxorubicin. Especially for patients with pulmonary tuberculosis or aged patients with primary bladder tumors, mitoxantrone and doxorubicin may be the tolerable and effective intravesical agents.

Administration, Intravesical↗

PubMed2000

Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial.

We have previously demonstrated a decrease in the incidence of acute graft-versus-host disease (GVHD) with the addition of methotrexate (MTX) to cyclosporine (CSP) and prednisone (PSE) chemotherapy in patients with leukemia. We have now completed a prospective randomized trial comparing the 3-drug regimen (CSP/MTX/PSE, including 3 doses of MTX) to the standard 2-drug regimen (CSP/MTX, including 4 doses of MTX) to investigate the benefit of PSE used up front for the prevention of acute and chronic GVHD. In the trial, 193 patients were randomized and 186 were included in the final analysis. All patients received a bone marrow graft from a fully histocompatible sibling donor. The preparatory regimen consisted of fractionated total-body irradiation (fTBI) and etoposide in all but 13 patients, who received fTBI and cyclophosphamide. The patients were randomized to receive either CSP/MTX/PSE or CSP/MTX. The 2 groups were well balanced with respect to diagnosis, disease stage, age, donor-recipient sex, and parity. In an intent-to-treat analysis, the incidence of acute GVHD was 18% (95% confidence interval [CI] 12-28) for the CSP/MTX/PSE group compared with 20% (CI 10-26) for the CSP/,MTX group (P = .60), with a median follow up of 2.2 years. Overall survival was 65% for those receiving CSP/MTX/PSE and 72% for those receiving CSP/MTX (P = .10); the relapse rate was 15% for the CSP/MTX/PSE group and 12% for the CSP/MTX group (P = .83). The incidence of chronic GVHD was similar (46% versus 52%; P = .38), with a follow-up of 0.7 to 6.0 years. Of interest, 21 patients went off study due to GVHD (5 in the CSP/MTX/PSE group and 16 in the CSP/MITX group [P = .02]), and 11 patients went off study because of alveolar hemorrhage (3 in the CSP/MTX/PSE group and 8 in the CSP/MTX group [P = .22]). The addition of PSE did not result in a higher incidence of infectious complications, bacterial (66% versus 58%), viral (77% versus 66%), or fungal (20% versus 20%), in those receiving CSP/MTX/PSE versus CSP/MTX, respectively. These data suggest that the addition of PSE was associated with a somewhat lower incidence of early posttransplantation complications but did not have a positive impact on the incidence of acute or chronic GVHD or event-free or overall survival.

Acute Disease↗

PubMed1987

Canadian multicenter randomized trial comparing sequential and alternating administration of two non-cross-resistant chemotherapy combinations in patients with limited small-cell carcinoma of the lung.

In order to assess the effect of scheduling of chemotherapy on the outcome of patients with limited small-cell lung cancer (SCLC), the Clinical Trials Group of the National Cancer Institute of Canada carried out a randomized trial comparing the alternation of cyclophosphamide, Adriamycin (Adria Laboratories, Columbus, OH; doxorubicin) and vincristine (CAV) with etoposide (VP-16) and cisplatin for six cycles to the administration of these two combinations in a sequential fashion (three cycles of CAV followed by three of VP-16/cisplatin). Three hundred eligible patients were enrolled on the trial from September 1981 to October 1984. All responding patients were also treated after completion of chemotherapy with thoracic irradiation in randomly allocated doses of 2,000 and 3,750 cGy. The complete response (CR) rate to chemotherapy was slightly, but not significantly, higher on the alternating arm (52% v 44%, P = .20). However, there was no difference in disease-free or overall survival on the alternating and sequential arms, respectively (47.3 weeks v 45.1 weeks, P = .26; 61.7 weeks v 59.5 weeks, P = .56). Data on the effect of radiotherapy dose on survival are not yet mature, but it does not appear the results of this portion of the trial will alter the interpretation of the chemotherapy comparison. Patient characteristics favorably influencing survival were female sex, good performance status, younger age, and absence of supraclavicular node involvement. Two interpretations of these and other results in SCLC are suggested: (1) the difference between the schedules used is too small for the predictions of the Goldie-Coldman model to be realized in a trial of this size, or (2) VP-16/cisplatin is actually a superior regimen and any schedule that exposes patients to these drugs early in treatment will produce improved results.

Adult↗

PubMed1993

A randomized trial of penicillin and streptomycin in the prevention of post-partum infection in Uganda.

We report findings of a randomized trial of penicillin and streptomycin to prevent post-partum infection conducted on 737 women who delivered consecutively at Kawempe Maternity Centre (KMC) in Kampala from 1st October, 1989 to 31st May, 1990. The objectives were: (i) to identify clinical post-partum infection using at least two of its symptoms and signs (fever, lower abdominal pain, lower abdominal tenderness, vaginal discharge); (ii) to identify the causes of post-partum infection using laboratory methods; and (iii) evaluate the effectiveness of prophylactic fortified procaine penicillin (PPF) and streptomycin on post-partum infection. Clinical infection occurred in 36.4% of the group not given antibiotics, 23.3% in the PPF group and 20.3% in the streptomycin group. Laboratory-confirmed infection occurred in 15.5% of the group not given antibiotics, 9.2% in the PPF group and 8.4% in the streptomycin group. However, severe laboratory-confirmed infection (severe clinical infection plus positive laboratory findings) occurred in 4.9% of the group not given antibiotics, 6.1% in the PPF group and 6.6% in the streptomycin group. In general, the organisms isolated included enterobacteria (35.9%), yeast and protozoa (31.6%), staphylococci (23.9%), streptococci (69%) and Neisseria (1.7%). The advantage of PPF and streptomycin was evident in most subgroups defined by clinical characteristics or laboratory findings. In view of the findings in this study, we believe that prophylactic antibiotics given in labor may have a role to play at reducing the incidence of post-partum infection. However, as the cost of antibiotics in developing countries is significant, the development of resistant organisms due to indiscriminate antibiotic use is also a concern and health resources are best used when targeted at specific populations, we feel that antibiotic prophylaxis should not be used routinely and that a more realistic view can be obtained by studying high-risk groups of women with more severe infection.

Adult↗

PubMed1997

Preoperative chemotherapy versus surgical therapy alone for squamous cell carcinoma of the esophagus: a prospective randomized trial.

OBJECTIVE: This study investigated the role of preoperative chemotherapy in squamous cell cancer of the esophagus. METHODS: A prospective randomized trial was undertaken in 147 patients: 74 received preoperative chemotherapy comprising cisplatin and 5-fluorouracil and 73 had surgical therapy alone. End points were cancer and therapy-related deaths. RESULTS: Sixty-six patients (89%) in the chemotherapy group underwent resection compared with 69 (95%) in the control group (p = not significant). Of the 60 patients who had resection after completing the chemotherapy program, 35 (58%) had a significant response, of whom four (6.7%) had a complete pathologic response. Postoperative mortality rates were 8.3% and 8.7% in the chemotherapy and control groups, respectively (p = not significant). Significant downstaging was evident with chemotherapy; curative resections were possible in 67% of these patients compared with 35% in the control group (p = 0.0003). T3 and T4 tumors were found in 67% and 91% of the chemotherapy and control groups, respectively (p = 0.0002). The respective figures for N1 disease were 70% and 88% (p = 0.009). An intent-to-treat analysis of survival showed no significant difference between the two groups. Median survivals were 16.8 and 13 months, respectively (p = 0.17). Of those who completed the chemotherapy and resection, responders fared better than control patients. Median survivals were 42.2 months and 13.8 months, respectively (p = 0.003). Median survival (8.3 months) was worse for nonresponders than for control patients (p = 0.03). The recurrence pattern suggested a significant reduction in locoregional disease with chemotherapy. CONCLUSIONS: Preoperative chemotherapy was safe and resulted in significant downstaging and an increased likelihood of curative resection. Survival was not better than that in the surgery-alone group, but responders did fare better than nonresponders.

Aged↗

PubMed1995

A prospective randomized trial of FK506-based immunosuppression after renal transplantation.

A group of 204 adult patients was entered into a prospective, randomized trial comparing FK506/prednisone with FK506/azathioprine/prednisone after renal transplantation between August 1, 1991 and October 11, 1992. The purpose of the study was to see if the addition of azathioprine would reduce the incidence of rejection and improve graft survival. The recipient population was unselected, with 61 (30%) patients undergoing retransplantation, 37 (18%) having a panel-reactive antibody greater than 40%, and 33 (16%) over 60 years of age. The mean recipient age was 43.8 +/- 13.7 years (range 17.6-78). The mean donor age was 34.0 +/- 20.1 years (range 0.3-75); 13% of the cadaveric kidneys were from pediatric donors less than 3 years of age and were transplanted en bloc. The mean cold ischemia time was 31.4 +/- 8.4 hr. Living donors were the source of 13% of the kidneys. The mean follow-up was 22 +/- 4 months (range 12-29). Overall one-year actual patient survival was 94%. Overall one-year actual graft survival was 87%. Patients starting on double therapy had a one-year actual patient survival of 96% and a one-year actual graft survival of 92%. Patients starting on triple therapy had a one-year actual patient survival of 91% (P = ns compared with double therapy), and a one-year actual graft survival of 82% (P < 0.02, compared with double therapy). Overall results with first cadaver transplants included a one-year actual patient survival of 94% and one-year actual graft survival of 88%, with no differences between double and triple therapy. The overall incidence of rejection was 48%, with 54% in the double therapy group and 41% in the triple therapy group (P < .07). The incidence of steroid-resistant rejection requiring antilymphocyte therapy (OKT3 or ATGAM) was 13%, and was not different between the double and triple therapy groups. The mean serum creatinine was 1.8 +/- 0.8 mg/dl. The mean BUN was 33 +/- 21 mg/dl, with no significant difference between the therapy groups. The mean serum cholesterol was 192 +/- 49 mg/dl. A total of 56% of the patients are off prednisone, and 35% of the patients are not taking any antihypertensive medications. Other complications included cytomegalovirus--14%; new-onset diabetes--16% (half of which was reversible); and posttransplant lymphoproliferative disorder--1%.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

PubMed1993

Short report: prospective, randomized trial comparing a single dose sodium phosphate regimen with PEG-electrolyte lavage for colonoscopy preparation.

We performed a prospective, randomized trial in 52 patients to see how preparation with a single-dose sodium phosphate solution regimen (Fleet Phospho-Soda), in which the entire 89 ml dose was given on the evening prior to colonoscopy, compared with conventional polyethylene glycol(PEG)-electrolyte lavage in terms of quality of colon cleansing and ease of patient preparation. Previous trials had utilized a two-dose sodium phosphate regimen in which one dose was given on the evening prior to colonoscopy and the other on the morning of the procedure. A nurse gave a questionnaire to the patient prior to colonoscopy, assessing how well the preparation was tolerated. The attending gastroenterologist graded the quality of colon cleansing, unaware of how the patient was prepared or tolerated the preparation (1 = excellent, 2 = good, 3 = fair, 4 = unsatisfactory). Both preparations were similarly tolerated. The overall quality of bowel preparation with PEG lavage was significantly better (mean score 1.62) than with the single-dose sodium phosphate regimen (mean score 2.85) (P = 0.0002). Of 26 patients, 2 (7.7%) undergoing preparation with PEG lavage were judged to have had an unsatisfactory preparation, compared with 8 of 26 patients (30.8%) receiving the sodium phosphate regimen (P = 0.075). We conclude that the single-dose sodium phosphate regimen is suboptimal for clinical practice and its use cannot be recommended.

Adult↗