Abdominal Neoplasms Neoplasms
Conditions
Interventions
This is a two-arm randomized controlled clinical trial, open-label (without masking). A total of 54 participants will be included, with 27 participants allocated to the Intervention Group and 27 parti
Sponsors
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older; patients undergoing open abdominal or pelvic surgery or perianal or perineal surgeries related to the specialties of digestive system surgery, coloproctology, gynecology, urology or general surgery
Exclusion criteria
Exclusion criteria: Patients who refuse to participate in the study; surgeries in which the collaborating surgeon or the surgical instrument technician refuses to participate in the study; urgent or emergency surgeries; patients undergoing open surgery after conversion from minimally invasive surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the total number of manual adjustments of the operating room light during the procedure, defined as the number of times the surgeon touches or repositions the surgical light handle, assessed through postoperative review of intraoperative video recordings by two independent evaluators with discrepancies resolved by consensus, with data collected from skin incision to skin closure, with the unit of measurement expressed as number of events per procedure, and results presented as absolute mean difference between groups with 95% confidence intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome is the total number of contacts with non sterile surfaces during the procedure, defined as the number of times any member of the surgical team touches non sterile areas, assessed through postoperative review of intraoperative video recordings, with data collected from skin incision to skin closure, with the unit of measurement expressed as number of events per procedure, and results presented as absolute mean difference between groups with 95% confidence intervals;The outcome is operative time defined as the duration of the surgical procedure, measured from skin incision to skin closure, with the unit of measurement expressed in minutes, and results presented as absolute mean difference between groups with 95% confidence intervals;The outcome is intraoperative complications defined as any unintended event occurring during surgery that requires additional intervention or alters the planned procedure, assessed during the intraoperative period and confirmed immediately after completion of the procedure, with the unit of measurement expressed as proportion of patients with at least one complication, and results presented as risk difference and risk ratio between groups;The outcome is surgeon satisfaction assessed using a structured questionnaire completed by the primary surgeon immediately after the end of the procedure, composed of six domains including overall satisfaction with surgical lighting, ease of maintaining adequate illumination, interruption of surgical workflow due to lighting, impact on concentration, impact on comfort and posture, and confidence in visualization of critical anatomical structures, with each domain rated on a five point scale ranging from very dissatisfied to very satisfied, with a composite mean score calculated when all items are completed, with unit of measurement expressed as individual item score from one to five and mean score from one to five, and results presented as absolute mean difference between groups with 95% confi | — |
Countries
BR
Contacts
Public ContactFrancisco Tustumi
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Outcome results
None listed