Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01534793
Brief Summary:
This observational study aims at describing the learning curve of the Holmium Enucleation of the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.
Detailed Description:
This is a prospective, multicentre observational study studying the learning curve of the HoLEP procedure, through auto-evaluation of the quality of the surgery by senior attending urologists introducing HoLEP in their current clinical practice. This is a single arm, not comparative study. The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale \[varying from 0 to 5\]. To be successful, a procedure must be scored 5/5. Each procedure is evaluated at the end of the surgical act by the surgeon himself. As secondary outcomes, the short term efficacy and safety parameters of the HoLEP technique will be evaluated through the following data prospectively collected:
* I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)
* I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)
* DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)
* Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)
* Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
* Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative)
* Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative)
* PSA blood testing (15 days before operation, at 6 and 12 months postoperative)One month post-operative questionnaire at one month post-operative
* Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative)
* Satisfaction of the intervention (at 1 and 12 months postoperative)
* Pathologic examination of the prostate tissue (at 1 months postoperative)
* Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,)
Time needed for each step of the procedure:
* prostatic capsule contact
* enucleation of the median lobe
* enucleation of the lateral lobes
* hemostasis
* morcellation Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)
* Tissue weight
* Irrigation volume
* Need for coagulation with another device
* Adverse events during the procedure
* Type of catheter after surgery
* Duration of the catheterization
* Post-operative irrigation (duration, volume, type)
* Hospital stay. The indications of the surgery are the usual indications for bladder outlet obstruction relief in ta context of low urinary tract symptoms due to benign prostatic hyperplasia, as an alternative to the other level 1
* Grade A recommended surgical techniques. The profile of every surgeon will be recorded in terms of surgical experience with age, number of previous endoscopic prostatic surgical procedures, number of laser procedures.
The study design is scheduled as follows:
* Inclusion visit (between D-25 and D-5 before surgery), for inclusion written informed consent as assessment of baseline data
* Surgical intervention (D0): performed as previously described in the literature, with assessment of perioperative data
* One month visit: one month data
* Six month visit: six months data
* One year visit: one year data Statistical analysis will be conducted under SAS9.2 as descriptive analysis for all data, CUSUM technique for main outcome criterion (Altman et al. Stat Med 1988 7 : 629-637 and modelisation of the learning curve.
Study:
NCT01534793
Study Brief:
Protocol Section:
NCT01534793