Gaballa 2015.
Trial name or title | Feasibility and functional outcome of laparoscopic nerve sparing radical hysterectomy (NCT02524756) |
Methods | Study type: interventional study Study design: phase III randomised controlled trial Intervention model: parallel assignment Masking: no masking Primary purpose: treatment outcome measures |
Participants | Participants’ characteristics: women aged 18 years or over Inclusion criteria
Exclusion criteria
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Interventions | Intervention: laparoscopic nerve‐sparing radical hysterectomy (type III/C1) Control: laparoscopic radical hysterectomy (type III/C2). |
Outcomes | Primary outcome measures: duration of postoperative catheterisation until PVR urine volume is less than 100 mL Secondary outcome measures: intraoperative complications, amount of blood intraoperative blood loss, operative time, occurrence of early postoperative complication within 30 days of operation, occurrence of late complications related to surgery more than 30 days postoperative Removal of urinary catheter on the third day postoperative without prior bladder training exercise and measurement of PVR |
Starting date | November 2014 |
Contact information | Principal Investigator: Khaled Gaballa, Assistant Lecturer of surgical oncology, Mansoura Universitry Study Chair: Adel Taha Denewar, MD, Ph.D, Head of surgical oncology department, Mansoura oncology centre, Mansoura University Study Director: Giovanni Scambia, MD,Ph.D, Head of the Department for Woman and Unborn Life Health Care‐ Catholic University of the Sacred Heart‐ Rome, Italy |
Notes | ClinicalTrials.gov Identifier: NCT02524756 |
PVR: postvoid residual urine volume