Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis
- Conditions
- Pheochromocytoma
- Interventions
- Drug: Selective alpha-1-antagonistDrug: Non-selective alpha-1-antagonist
- Registration Number
- NCT04557072
- Lead Sponsor
- Jagiellonian University
- Brief Summary
Our aim was to systematically evaluate the current data on the efficacy of pretreatment with either selective or nonselective alpha-blockade on the hemodynamic instability and morbidity during pheochromocytoma resection.
- Detailed Description
RCTs and non-randomized controlled studies comparing preoperative selective alpha-blockade (SAB) with nonselective alpha-blockade (NAB) in pheochromocytoma surgery in adults were eligible for inclusion.
All identified articles will be screened by title and abstract. Two independent reviewers will review potentially relevant articles in detail. Dissent will be resolved by consensus and the recommendation of a third observer as required. Data from the included studies will be extracted independently by the two researchers. The Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines will be used for reporting.
Quality of Assessment The Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool will be used to assess the quality of included non-randomized studies. The risk of bias of randomized studies will be assessed using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions .The quality of each study will be assessed by two of the authors. In the event of uncertainties regarding the levels of the studies' quality, a third reviewer will be consulted.
Analysis will be performed using RevMan (Version 5.3, freeware from the Cochrane Collaboration). Odds ratios and their associated 95% confidence intervals will be pooled for dichotomous outcomes using the Mantel-Haenszel random-effects method. Continuous outcomes will be pooled as weighted mean difference (WMD) with 95 per cent confidence interval using the inverse-variance random-effects method. WMD and OR will be presented on the graphs as squares, and pooled WMD and OR will be presented as diamond.
P ≤ 0.05 will be considered a statistically significant difference for hypothesis and P \< 0.10 for heterogeneity testing, respectively.
Heterogeneity between the studies will be estimated by statistical tests I2 and Cochran's Q tests.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1344
- All patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection
- Patients who did not receive alpha blockade
- Patients not undergoing surgery
- No comparison for selective and non-selective pretreatment in the study
- Studies without primary or sufficient data (reviews, guidelines, meeting abstracts, letters),
- Studies reported in a language other than English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description The selective alpha-blockade group Selective alpha-1-antagonist Patients treated with selective alpha-blockade before pheochromocytoma surgery The non-selective alpha-blockade group Non-selective alpha-1-antagonist Patients treated with non-selective alpha-blockade before pheochromocytoma surgery
- Primary Outcome Measures
Name Time Method Intraoperative maximum systolic blood pressure (mm Hg) intraoperative
- Secondary Outcome Measures
Name Time Method Intraoperative minimum systolic blood pressure (mm Hg) intraoperative Frequency of systolic blood pressure >160 mmHg intraoperative Intraoperative maximum diastolic blood pressure (mm Hg) intraoperative intraoperative maximum heart rate (beats/min) intraoperative Intraoperative vasopressors administration intraoperative (number of patients requiring vasopressors administration)
Intraoperative vasodilators administration intraoperative (number of patients requiring vasopressors administration)
Operative time (min) intraoperative Overall morbidity 30 days Length of hospital stay (days) Up to 30 days Postoperative minimum systolic blood pressure (mm Hg) 24 hours Postoperative vasopressors administration 24 hours (number of patients requiring vasopressors administration)
Mortality 30 days Time of alpha-adrenolytics administration Up to 30 days
Trial Locations
- Locations (1)
2nd Department of General Surgery, Jagiellonian University Medical College
🇵🇱Kraków, Polska, Poland