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. 2019 Feb 12;2019(2):CD012828. doi: 10.1002/14651858.CD012828.pub2

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
  • Age > 18 years

  • Karnofsky > 80, or American Society of Anaethesiology (ASA) I‐II

  • Stage IA2‐IB1‐IB2‐IIA1‐IIA2‐IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging

  • Stage II endometrial cancer


Exclusion criteria
  • Non‐invasive cancer

  • Pregnancy

  • Bladder dysfunction detected prior to surgery

  • Previous pelvic lymphadenectomy

  • Tumour recurrence

  • Incomplete surgery, unresectable lesion

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