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Results for “Randomised Controlled Trial”

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PubMed2004

Treatment outcomes after highly active antiretroviral therapy: a meta-analysis of randomised controlled trials.

This systematic review summarises the evidence for treatment efficacy and tolerability of highly active antiretroviral therapies containing two nucleoside reverse transcriptase inhibitors (NRTI) with a protease inhibitor (PI), compared with two NRTIs alone for the treatment of HIV-1 infection in randomised controlled trials. Three electronic databases (Medline, Embase, and the Cochrane Library) were searched up to December 2003. 16 randomised controlled trials met the inclusion criteria and were included in the analysis from 328 articles screened. The pooled analysis indicated that treatment with two NRTIs with a PI is more effective in achieving viral suppression than two NRTIs alone (relative risk [RR] 3.44, 95% confidence interval [CI] 2.43-4.87). However, the RR for discontinuation of treatment due to adverse events of treatment with two NRTIs with a PI compared with two NRTIs alone was 1.81 (95% CI 1.17-2.79). The benefits of treatment with two NRTIs and a PI are substantial among those who can tolerate the regimen in comparison with treatment with two NRTIs alone.

Acquired Immunodeficiency Syndrome↗

PubMed2005

Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review.

OBJECTIVE: To investigate whether selective serotonin reuptake inhibitor (SSRI) antidepressants are associated with an increased risk of suicide related outcomes in adults. DESIGN: Meta-analysis of randomised controlled trials of SSRIs compared with placebo in adults submitted by pharmaceutical companies to the safety review of the Medicines and Healthcare products Regulatory Agency (MHRA). PARTICIPANTS: Over 40,000 individuals participating in 477 randomised controlled trials. MAIN OUTCOME MEASURES: Suicide, non-fatal self harm, and suicidal thoughts. RESULTS: An estimated 16 suicides, 172 episodes of non-fatal self harm, and 177 episodes of suicidal thoughts were reported. We found no evidence that SSRIs increased the risk of suicide, but important protective or hazardous effects cannot be excluded (odds ratio 0.85, 95% credible interval 0.20 to 3.40). We found weak evidence of an increased risk of self harm (1.57, 0.99 to 2.55). Risk estimates for suicidal thoughts were compatible with a modest protective or adverse effect (0.77, 0.37 to 1.55). The relative frequency of reported self harm and suicidal thoughts in the trials compared with suicide indicates non-fatal end points were under-recorded. CONCLUSION: Increased risks of suicide and self harm caused by SSRIs cannot be ruled out, but larger trials with longer follow up are required to assess the balance of risks and benefits fully. Any such risks should be balanced against the effectiveness of SSRIs in treating depression. When prescribing SSRIs, clinicians should warn patients of the possible risk of suicidal behaviour and monitor patients closely in the early stages of treatment.

Adult↗

PubMed2004

Hidden evidence to the West: multicentre, randomised, controlled trials in sepsis and systemic inflammatory response syndrome in Japanese journals.

OBJECTIVE: To assess multicentre, randomised, controlled trials (MC-RCTs) of systemic inflammatory response syndrome (SIRS) and sepsis conducted in Japan, published in Japanese and not available to English-language medical databases. DESIGN: Methodological review. SUBJECTS: All Japanese RCTs relevant to SIRS and sepsis. INTERVENTION: Identification of manuscripts using a Japanese electronic library. Critical analysis of methodology and reporting quality using a modified Methodological Quality Assessment Score and the CONSORT group check list. MEASUREMENTS AND RESULTS: Three MC-RCTs were identified. In the first, 147 patients with septic shock were randomised to methylprednisolone (1000 mg i.v.) or placebo. In the second, 221 patients were randomised to 0.20 mg/kg per h or 0.004 mg/kg per h of sivelestat for acute lung injury with SIRS. In the third, 504 patients were randomised to immunoglobulin (5 g for 3 days) or to a control group. The average methodological quality score was higher than that of equivalent Western trials. The reporting quality (CONSORT checklist) was comparable to Western studies published during the same period. CONCLUSIONS: Despite sound methodology and quality, the information obtained from relatively large Japanese critical care trials is not widely available to English-speaking investigators and therefore might be ignored in meta-analyses.

Anti-Inflammatory Agents↗

PubMed1987

Meta-analysis of randomised controlled trials of nicotine chewing-gum.

A meta-analysis was made of fourteen randomised controlled trials that evaluated the efficacy of nicotine chewing-gum in stopping patients smoking. The combined success rates in specialised cessation clinics are significantly higher with nicotine gum (27%) than with placebo gum (18%) at 6 months (n = 734), and 23% and 13% at 12 months, respectively. In contrast, success rates in general medical practices are similar with nicotine gum (11.4%) and with placebo gum (11.7%) at 6 months (n = 1022). However, in general practices, the success rates are 17% for nicotine gum and 13% for the no gum control at 4-6 months, and 9% and 5% at 12 months, a significant difference between the treatments at each time (n = 2238). The data suggest that proper use of nicotine gum in specialised clinics will increase the rate of stopping patients smoking. The use of the gum in general medical practices is questionable.

Carbon Monoxide↗

PubMed1992

Randomised controlled trial of Doppler ultrasound screening of placental perfusion during pregnancy.

We have done a randomised controlled trial to assess the effect on primary management and outcome of routine doppler ultrasound examinations of the umbilical and uterine arteries during pregnancy. Over 9 months, 2600 women with singleton pregnancies were recruited from a general obstetric population. Of 2475 women who delivered in hospital after 20 weeks' gestation, 1246 had been allocated at random to receive standard antenatal care with routine doppler examinations. The first doppler ultrasound was done at 19-22 weeks' gestation, and thereafter examinations were monthly if the pregnancy was considered high risk (192) or once at 32 weeks if considered low risk (1054). The control group of 1229 women received standard, antenatal care without doppler ultrasonography. The study groups did not differ in number of antenatal admissions or cardiotocographs, gestational age at delivery, method of delivery, frequency of deliveries with fetal distress, or need for resuscitation or admission to the neonatal intensive care unit. More perinatal deaths occurred in the doppler group (17 vs 7, relative risk 2.4, 95% Cl 1.00-5.76), but only 1 of 11 normally formed stillbirths and none of the 4 normally formed neonatal deaths after 24 weeks' gestation had an abnormal umbilical-artery doppler examination. We did not demonstrate any improvement in neonatal outcome by routine doppler ultrasound screening of a general obstetric population.

Adult↗

PubMed2001

Is voice therapy an effective treatment for dysphonia? A randomised controlled trial.

OBJECTIVES: To assess the overall efficacy of voice therapy for dysphonia. DESIGN: Single blind randomised controlled trial. SETTING: Outpatient clinic in a teaching hospital. PARTICIPANTS: 204 outpatients aged 17-87 with a primary symptom of persistent hoarseness for at least two months. INTERVENTIONS: After baseline assessments, patients were randomised to six weeks of either voice therapy or no treatment. Assessments were repeated at six weeks on the 145 (71%) patients who continued to this stage and at 12-14 weeks on the 133 (65%) patients who completed the study. The assessments at the three time points for the 70 patients who completed treatment and the 63 patients in the group given no treatment were compared. MAIN OUTCOME MEASURES: Ratings of laryngeal features, Buffalo voice profile, amplitude and pitch perturbation, voice profile questionnaire, hospital anxiety and depression scale, clinical interview schedule, SF-36. RESULTS: Voice therapy improved voice quality as assessed by rating by patients (P=0.001) and rating by observer (P<0.001). The treatment effects for these two outcomes were 4.1 (95% confidence interval 1.7 to 6.6) points and 0.82 (0.50 to 1.13) points. Amplitude perturbation showed improvement at six weeks (P=0.005) but not on completion of the study. Patients with dysphonia had appreciable psychological distress and lower quality of life than controls, but voice therapy had no significant impact on either of these variables. CONCLUSION: Voice therapy is effective in improving voice quality as assessed by self rated and observer rated methods.

Adolescent↗

PubMedDate not supplied

Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial.

BACKGROUND: Undernutrition is common in patients admitted with stroke. We aimed to establish whether the timing and route of enteral tube feeding after stroke affected patients' outcomes at 6 months. METHODS: The FOOD trials consist of three pragmatic multicentre randomised controlled trials, two of which included dysphagic stroke patients. In one trial, patients enrolled within 7 days of admission were randomly allocated to early enteral tube feeding or no tube feeding for more than 7 days (early versus avoid). In the other, patients were allocated percutaneous endoscopic gastrostomy (PEG) or nasogastric feeding. The primary outcome was death or poor outcome at 6 months. Analysis was by intention to treat. FINDINGS: Between Nov 1, 1996, and July 31, 2003, 859 patients were enrolled by 83 hospitals in 15 countries into the early versus avoid trial. Early tube feeding was associated with an absolute reduction in risk of death of 5.8% (95% CI -0.8 to 12.5, p=0.09) and a reduction in death or poor outcome of 1.2% (-4.2 to 6.6, p=0.7). In the PEG versus nasogastric tube trial, 321 patients were enrolled by 47 hospitals in 11 countries. PEG feeding was associated with an absolute increase in risk of death of 1.0% (-10.0 to 11.9, p=0.9) and an increased risk of death or poor outcome of 7.8% (0.0 to 15.5, p=0.05). INTERPRETATION: Early tube feeding might reduce case fatality, but at the expense of increasing the proportion surviving with poor outcome. Our data do not support a policy of early initiation of PEG feeding in dysphagic stroke patients.

Activities of Daily Living↗

PubMed2002

Effect of faecal occult blood screening on mortality from colorectal cancer: results from a randomised controlled trial.

BACKGROUND: Three large randomised trials have shown that screening for colorectal cancer using faecal occult blood (FOB) tests can reduce the mortality from this disease. Two national pilot studies have recently been launched in the UK to investigate the feasibility of population screening for colorectal cancer in the National Health Service. The largest of the randomised trials was conducted in Nottingham and randomised 152 850 individuals between the ages of 45 and 74 years to receive biennial Haemoccult (FOB) test kit (intervention group) or to a control group. AIMS: We have compared the mortality in the intervention group compared with the control group. METHODS: The 152 850 randomised individuals were followed up through local health records and central flagging (Office for National Statistics) over a median follow up period of 11 years. RESULTS: At a median follow up of 11 years there was a 13% reduction in colorectal cancer mortality (95% confidence interval 3-22%) in the intervention group despite an uptake at first invitation of only approximately 50%. The mortality reduction for those accepting screening was 27%. The reduction in mortality was independent of sex and site of tumour. There was no significant difference in mortality from causes other than colorectal cancer between the intervention and control groups. CONCLUSIONS: Although the reduction in colorectal cancer mortality was sustained, further follow up of this population is required to determine whether a significant reduction in the incidence of colorectal cancer will be achieved.

Aged↗

PubMed2002

Promoting urinary continence in women after delivery: randomised controlled trial.

OBJECTIVES: To test the effectiveness of a physiotherapist delivered intervention designed to prevent urinary incontinence among women three months after giving birth. DESIGN: Prospective randomised controlled trial with women randomised to receive the intervention (which entailed training in pelvic floor exercises and incorporated strategies to improve adherence) or usual postpartum care. SETTING: Postpartum wards of three tertiary teaching hospitals in the Hunter region, New South Wales, Australia. PARTICIPANTS: Women who had forceps or ventouse deliveries or whose babies had a high birth weight (> or =4000 g), or both-676 (348 in the intervention group and 328 in the usual care group) provided endpoint data at three months. MAIN OUTCOME MEASURES: Urinary incontinence at three months measured as a dichotomous variable. The severity of incontinence was also measured. Self report of the frequency of performance of pelvic floor exercises was recorded. RESULTS: At three months after delivery, the prevalence of incontinence in the intervention group was 31.0% (108 women) and in the usual care group 38.4% (125 women); difference 7.4% (95% confidence interval 0.2% to 14.6%, P=0.044). At follow up significantly fewer women with incontinence were classified as severe in the intervention group (10.1%) v (17.0%), difference 7.0%, 1.6% to 11.8%). The proportions of women reporting doing pelvic floor exercises at adequate levels was 84% (80% to 88%) for the intervention group and 58% (52% to 63%) for the usual care group (P=0.001). CONCLUSIONS: The intervention promoting urinary continence reduced the prevalence of urinary incontinence after giving birth, particularly its severity, and promoted the performance of pelvic floor exercises at adequate levels; both continence and adherence to the programme were measured at three months after delivery in women who had forceps or ventouse deliveries or babies weighing 4000 g or more.

Adult↗

PubMed2005

Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials.

Devices for neuromuscular electrical stimulation (NMES) are increasingly used by individuals without specific injuries and are standard equipment in most physical therapy practices. The most often stimulated muscle group is the quadriceps femoris. We designed a systematic review and meta-analysis of randomised controlled trials to determine whether NMES is an effective modality for strength augmentation of the quadriceps femoris. A full content search for randomised controlled trials was performed in Medline, Embase, Cinahl, the Cochrane Controlled Trials Register and the Physical Therapy Evidence Database. Maximum volitional isometric or isokinetic muscle torque in Nm was used as main outcome measure.Thirty-five trials were included and evaluated. A fundamental distinction was made between the trials using subjects with unimpaired quadriceps femoris muscles and the trials using post-injury or post-operative subjects. In the unimpaired quadriceps subgroup, meta-analyses were performed for the comparisons 'NMES versus no exercises' and 'NMES versus volitional exercises'. All other comparisons were evaluated descriptively. The included trials were generally of poor quality and meta-analytic data indicate that publication bias may be present. The evaluated data suggest that, both for the unimpaired and impaired quadriceps, NMES makes sense compared with doing no exercises but volitional exercises appear to be more effective in most situations.Based on the available evidence, NMES may only be preferred over volitional training for within-cast muscle training and perhaps in specific situations where volitional training does not receive sufficient patient compliance. Further research should be directed toward identifying the clinical impact at activity and participation levels and the optimal stimulation parameters of this modality.

Electric Stimulation↗

PubMed2005

Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the most appropriate surgical method of hysterectomy (abdominal, vaginal, or laparoscopic) for women with benign disease. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and Biological Abstracts. SELECTION OF STUDIES: Only randomised controlled trials were selected; participants had to have benign gynaecological disease; interventions had to comprise at least one hysterectomy method compared with another; and trials had to report primary outcomes (time taken to return to normal activities, intraoperative visceral injury, and major long term complications) or secondary outcomes (operating time, other immediate complications of surgery, short term complications, and duration of hospital stay). RESULTS: 27 trials (total of 3643 participants) were included. Return to normal activities was quicker after vaginal than after abdominal hysterectomy (weighted mean difference 9.5 (95% confidence interval 6.4 to 12.6) days) and after laparoscopic than after abdominal hysterectomy (difference 13.6 (11.8 to 15.4) days), but was not significantly different for laparoscopic versus vaginal hysterectomy (difference -1.1 (-4.2 to 2.1) days). There were more urinary tract injuries with laparoscopic than with abdominal hysterectomy (odds ratio 2.61 (95% confidence interval 1.22 to 5.60)), but no other intraoperative visceral injuries showed a significant difference between surgical approaches. Data were notably absent for many important long term patient outcome measures, where the analyses were underpowered to detect important differences, or they were simply not reported in trials. CONCLUSIONS: Significantly speedier return to normal activities and other improved secondary outcomes (shorter duration of hospital stay and fewer unspecified infections or febrile episodes) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy is preferable to abdominal hysterectomy, although it brings a higher chance of bladder or ureter injury.

Female↗

PubMed1998

A randomised controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair.

OBJECTIVE: To test the hypothesis that intravenous antibiotics given intra-operatively reduce the failure rate of vesico-vaginal fistula repair. DESIGN: A single blind, randomised controlled trial. SETTING: A district hospital in Benin, West Africa. POPULATION: Seventy-nine women undergoing repair of an obstetric vesico-vaginal fistula by a single surgeon at Hopital Evangelique; two women had repeat operations. METHODS: Participants in the treatment group (n = 41) received ampicillin 500 mg intra-operatively. Controls (n = 40) received no prophylactic antibiotics. MAIN OUTCOME MEASURES: Failure of fistula closure and objective incontinence (a positive pad test) at hospital discharge. Secondary outcomes included febrile morbidity, other antibiotic use and urinary infection. RESULTS: Antibiotic prophylaxis did not reduce the odds of failed repair (OR 2.1 95% CI 0.75-6.1) or of objective incontinence (OR 1.9; 95% CI 0.72-5.1). The women in the antibiotic prophylaxis group received less post-operative antibiotics and had less urinary infections at day 10. CONCLUSIONS: Prophylactic antibiotics should not be used in vesico-vaginal fistulae repair in the developing world outside randomised controlled trials.

Ampicillin↗

PubMed1998

Intra-umbilical vein injection and retained placenta: evidence from a collaborative large randomised controlled trial. Grupo Argentino de Estudio de Placenta Retenida.

OBJECTIVE: To determine whether intra-umbilical vein injection with saline solution, with or without oxytocin, reduces the need for manual removal of placenta compared with expectant management. DESIGN: Multicenter, randomised controlled trial. SETTING: Eleven hospitals in four cities of Argentina: Buenos Aires, Corrientes, Rosario, and Salta. PARTICIPANTS: Two hundred and ninety-one women showing no evidence of placental separation thirty minutes after vaginal delivery. INTERVENTIONS: Three different management strategies: 1. intra-umbilical vein injection of saline solution plus oxytocin; 2. intra-umbilical vein injection of saline solution alone; and 3. expectant management. MAIN OUTCOME MEASURES: Primary: manual removal of the placenta. Secondary: blood loss after trial entry, haemoglobin level at 24 to 48 hours and at 40 to 45 days after delivery, blood transfusion, curettage, infection, and days of hospital stay. RESULTS: Rates of subsequent manual removal were similar: intra-umbilical vein injection of saline solution plus oxytocin (58%; RR 0.92; 95% CI 0.73-1.15), or saline alone (63%; RR 1.00; 95% CI 0.80-1.24), compared with expectant management (63%). There were also no detectable effects of the active managements on any of the secondary measures of outcome. CONCLUSIONS: Based on evidence available from randomised controlled trials, including this trial, it is unlikely that intra-umbilical injection with or without oxytocin, is clinically useful. We recommend that this intervention should not be used in third stage management of labour.

Female↗

PubMed2001

Limitations in randomised controlled trials evaluating drug effects in mania.

Considering the increasing number of drugs evaluated for mania in randomised controlled trials (RCTs) and the potential discrepancies between recommendations based on RCTs and the antimanic treatment given in clinical practice, this paper addresses some issues related to RCTs on drug effects in mania. One major question raised in the paper is to what extent selection prior to the point of randomisation in RCTs in mania may limit the applicability of study results to patients seen in ordinary clinical practice. Although such limitations in generalisability can be difficult to investigate empirically, it is emphasised that they should be openly discussed in the reports of RCTs. Another major focus is the issue of evaluation and interpretation of outcome, including a discussion of various response criteria based on mania rating scale scores. It is pointed out that essential criteria of dimensionality have only been sufficiently evaluated for the Bech-Rafaelsen Mania Rating Scale, although the fulfilment of such criteria are prerequisites for adding up the item scores to a total score reflecting the severity of mania. It is suggested that response defined as a decline in mania score below a certain limit may have some advantages over the commonly used 50% reduction criterion. The issues arising from the unusual high drop-out rates of around 50% are also addressed. Despite the fact that we need rigorous placebo-controlled trials to establish antimanic efficacy of new compounds, we also need large scale pragmatic studies using broad inclusion criteria, comparing the various treatments, alone or in combination, to investigate how they work in clinical practice. These studies maybe randomised but open and use simple but relevant outcome measures.

Antimanic Agents↗

PubMed2004

Full publication of abstracts of randomised controlled trials published at International Continence Society meetings'.

AIMS: To find out how many abstracts reporting randomised controlled trials (RCTs) that are submitted to scientific meetings of the International Continence Society (ICS) are later published in full, and any predictors of full publication. MATERIALS AND METHODS: The appropriate issues of "Neurourology and Urodynamics" and the Proceedings of the ICS for 1998 and 1999 were hand-searched for the abstracts reporting RCTs. Bibliographic databases (Cochrane Controlled Trials Register, MEDLINE, EMBASE, Healthstar, Psychlit, CINAHL) were searched, using the authors' names, to find full publications. Authors were contacted when no full publication was found to check that all full publications had been found. This was repeated for 1987. RESULTS: Sixty-three abstracts reporting RCTs were found in 1998 and 1999. Twenty-five of these (40%) were followed by full publication. The only characteristic that predicted full publication was the use of a no treatment control group. In 1987, 16 of 19 abstracts (84%) went on to be published in full. CONCLUSIONS: The rate of full publication of abstracts reporting RCTs submitted to recent ICS meetings is low. It is lower than the rate of 56% found in other meetings. As it is widely regarded as unethical not to publish in full, ICS members should make every effort to write-up studies for peer-reviewed publication.

Abstracting and Indexing↗

PubMed2026

Long-term efficacy of cognitive behavioural therapy for insomnia (CBT-I) on depressive symptoms: A systematic review and meta-analysis of randomised controlled trials.

Depressive symptoms are common in individuals with persistent insomnia. Previous meta-analyses of randomised controlled trials (RCTs) showed that cognitive behavioural therapy for insomnia (CBT-I) can reduce depressive symptoms at post-treatment. However, the long-term maintenance of these improvements has never been systematically examined. To fill-in this gap, we conducted a systematic review and meta-analysis of the long-term (≥3 months) effects of CBT-I on depressive symptoms. The review was registered in PROSPERO (CRD420251146061). Only RCTs in adults with insomnia were considered. Pubmed, Scopus, Psycinfo, CINAHL, and Medline were searched up to 12 September 2025 with no predefined time constraints. From 5359 records initially retrieved, we included 53 articles reporting on 13,608 individuals. After outliers removal, random effects meta-analysis showed that CBT-I was superior to control conditions in reducing depressive symptoms at 3 [k = 29, d = -.35, [95% CI: -.49 to -.21], p < .001], 6 [k = 29, d = -.32, [95% CI: -.59 to -.05], p = .018], and 12 [k = 10, d = -.25, [95% CI: -.39 to -.12], p < .001] months follow-ups. Results demonstrate that the effects of CBT-I on depressive symptoms are sustained throughout the year following treatment, although effects may decline over time.

Humans↗

PubMed2005

A prospective, randomised controlled trial of an aged care nurse intervention within the Emergency Department.

The aim of this randomised controlled trial involving 224 elderly patients was to determine whether early geriatric assessment (in the form of an aged care nurse intervention based in the emergency department) reduced admission to the hospital, length of inpatient stay (LOS), or functional decline during the hospitalisation. Baseline geriatric assessments were recorded in the medical files of intervention patients (n = 114). The nurse also liaised with the patients' carers and health care providers, organised referrals for out-of-hospital assessment and support services, and assisted in the care of those admitted as inpatients by documenting suggestions for assessment and referral. Assessment data from control patients (n = 110) were withheld, and the nurse had no further involvement in their inpatient or outpatient care. One hundred and seventy-one patients (76%) were admitted to the hospital, for a median LOS of 10 days. The nurse successfully identified those needing admission (odds ratio [OR], 14.0; 95% confidence interval [CI], 2.6-75.1). Thirty-nine of 160 inpatients with available data (24%) had a functional deterioration during the hospitalisation. The intervention had no significant effect on admission to the hospital (OR, 0.7; CI, 0.3-1.7), LOS (hazard ratio, 1.1; CI, 0.7-1.5) or functional decline during the hospitalisation (OR, 1.3; CI, 0.5-3.3).

Activities of Daily Living↗

PubMed1998

Bassini repair compared with laparoscopic repair for primary inguinal hernia: a randomised controlled trial.

OBJECTIVE: To compare the effectiveness of open and laparoscopic primary inguinal hernia repair. DESIGN: Randomised controlled trial. SETTING: University hospital, The Netherlands. SUBJECTS: 87 patients had 103 open repairs and 88 patients had 114 laparoscopic repairs between November 1993 and July 1995. INTERVENTIONS: Laparoscopic repair by the transabdominal preperitoneal (TAPP) technique and open repair by the Bassini technique. MAIN OUTCOME MEASURES: Recurrence, morbidity, pain, and duration of convalescence. RESULTS: Operating time was longer for laparoscopy (mean (SD): 82 (28) compared with 45 (15) minutes p < 0.001). Patients in the Bassini group had higher postoperative pain scores (mean (SD)VAS: 2.9 (1.6) compared with 2.0 (1.6) p=0.002), used more analgesics (median total intake: 2 (0-54) compared with 0 tablets (0-42) p=0.008), and needed a longer convalescence time (mean (SD) time to return to work: 22 (12.6) compared with 14 (10.1) days p < 0.001; mean (SD) time to return to physical activities: 27 (12.6) compared with 17 (12.2) days p < 0.001). Mean follow up was 24 months. Recurrence rates were 21% (22/ 103) after Bassini and 6% (7/114) after laparoscopic repair (p=0.001). CONCLUSION: Laparoscopic hernia repair is a safe operation, which has obvious advantages over the Bassini repair in terms of pain, use of analgesic drugs, resumption of activities, and recurrence. A disadvantage of the laparoscopic repair is the longer operating time.

Analgesics↗