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Comparison between laparoscopic (keyhole surgery) and robot-assisted surgery for patients with prostate cancer

Comparison of laparoscopic and robot-assisted radical prostatectomy for patients with localized prostate cancer: analysis of benefits and complications in a prospective randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11552140
Enrollment
100
Registered
2022-06-10
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical treatment of localized prostate cancer Surgery

Interventions

All patients who are candidates for radical prostatectomy will be randomised into two groups: - Group A: will undergo laparoscopic radical prostatectomy (LRP)
- Group B: will undergo robot-assisted radical prostatectomy (RALP). A two-armed randomisation scheme will be generated by means of a specific "query" to the website www.randomization.com. A typical v

Sponsors

University of Turin
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged between 50 and 75 years 2. Diagnosed with localised or locally advanced prostate adenocarcinoma (clinical stage T1-2 or T3, in each case N0, M0) 3. Gleason score between 2 and 10 4. PSA <20ng/ml

Exclusion criteria

Exclusion criteria: Patients who withdraw consent

Design outcomes

Primary

MeasureTime frame
1. Postoperative urinary continence will be assessed with ICS questionnaire at 1, 3, 6, 12, 60 and 120 months after surgery. 2. Postoperative erectile function will be assessed with IIEF5 questionnaire at 1, 3, 6, 12, 60 and 120 months after surgery.

Secondary

MeasureTime frame
1. Serum PSA levels will be assessed at 1, 3, 6, 12, 60 and 120 months after surgery 2. Intraoperative complications will be assessed using Clavien-Dindo scale during the intervention 3. Postoperative complications will be assessed using Clavien-Dindo scale at 1, 12, 60 and 120 months after surgery

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026