Clinical trial NCT04557072: Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis
Official title: Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pheochromocytoma
Keywords: pheochromocytoma, surgery, alpha-blockade
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 1344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RCTs and non-randomized controlled studies comparing preoperative selective α-blockade (SAB) with nonselective α-blockade (NAB) in pheochromocytoma surgery in adults were eligible for inclusion.

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.

Eligibility criteria: Inclusion Criteria:

* All patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intraoperative maximum systolic blood pressure (mm Hg)
timeFrame: intraoperative
Secondary outcomes:
measure: Frequency of systolic blood pressure >160 mmHg
timeFrame: intraoperative
measure: Intraoperative maximum diastolic blood pressure (mm Hg)
timeFrame: intraoperative
measure: intraoperative maximum heart rate (beats/min)
timeFrame: intraoperative
measure: Intraoperative minimum systolic blood pressure (mm Hg)
timeFrame: intraoperative
measure: Intraoperative vasopressors administration
timeFrame: intraoperative
measure: Intraoperative vasodilators administration
timeFrame: intraoperative
measure: Operative time (min)
timeFrame: intraoperative
measure: Overall morbidity
timeFrame: 30 days
measure: Length of hospital stay (days)
timeFrame: Up to 30 days
measure: Postoperative minimum systolic blood pressure (mm Hg)
timeFrame: 24 hours
measure: Postoperative vasopressors administration
timeFrame: 24 hours
measure: Mortality
timeFrame: 30 days
measure: Time of alpha-adrenolytics administration
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
state: Polska
Study officials:
References: