QUAPELLA (QUAlity of Prostate Enucleation by LUMENIS - Laser)
This study is currently recruiting participants.
Verified March 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01534793
First received: January 25, 2012
Last updated: March 16, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Benign Prostatic Hyperplasia |
Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study Evaluating the Quality of Laser Enucleation of the Prostate Using a LUMENIS Laser Device |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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]. [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at 6 and 12 months postoperative) ] [ Designated as safety issue: No ]
- I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at 1, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative) [ Time Frame: 15 days before operation, and at 12 months postoperative ] [ Designated as safety issue: No ]
- Urinary flow rate I-PSS symptom score (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at day 0, and at 1, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- Postvoid residual volume (15 days before operation, at day 0, and at 1, 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at day 0, and at 1, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- Ultrasound examination of the prostate (15 days before operation, at 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- PSA blood testing (15 days before operation, at 6 and 12 months postoperative) [ Time Frame: 15 days before operation, at 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- One month post-operative questionnaire [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
- Evaluation of adverse events (the day of operation, at 1, 6 and 12 months postoperative) [ Time Frame: the day of operation, at 1, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
- Satisfaction of the intervention (at 1 and 12 months postoperative) [ Time Frame: at 1 and 12 months postoperative ] [ Designated as safety issue: No ]
- Pathologic examination of the prostate tissue [ Time Frame: at 1 month postoperative ] [ Designated as safety issue: No ]Pathologic examination of the prostate tissue (at 1 month postoperative)
- Blood levels of sodium, haemoglobin, and haematocrit (15 days before intervention, immediately after intervention,) [ Time Frame: 15 days befor intervention, immediately after intervention ] [ Designated as safety issue: No ]
- Intervention duration [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]
- Time needed for each step of the procedure [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]
Time needed for each step of the procedure:
- prostatic capsule contact
- enucleation of the median lobe
- enucleation of the lateral lobes
- hemostatsis
- morcellation
- Laser data [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]Laser data (duration, Joules number number of fibers used, fibre type, morcellator ans nephroscope type)
- Tissue weight [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]
- Irrigation volume [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days ] [ Designated as safety issue: No ]
- Need for coagulation with another device [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]
- Adverse events at the day of operation, at 1, 6,12 months post-operative [ Time Frame: the day of operation, at 1, 6,12 months post-operative ] [ Designated as safety issue: No ]
- Type of catheter at the surgery [ Time Frame: participants will be followed for the duration of the intervention, an expected average of 1 hour ] [ Designated as safety issue: No ]
- Duration of the catheterization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days ] [ Designated as safety issue: No ]
- Post-operative irrigation (duration, volume, type) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days ] [ Designated as safety issue: No ]
- Hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HoLEP
Holmium Laser Enucleation of the Prostate
|
Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
Under regional or general anaesthesia Urethroscopy to check the location of the prostatic capsule Enucleation of the prostatic lobes (median if present, then lateral lobes)Hemostasis Morcellation Device : LUMENIS Laser
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia
Criteria
Inclusion Criteria:
- Male patients over 50
- Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
- Protocol accepted by patient (signed informed consent)
- Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia, since at least 3 months, with indication of surgical relief of bladder outlet obstruction , with International prostate symptom score (I-PSS)≥ 12 and a bother score ≥ 3
- Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry
- Prostate weight between 40 and 80 grams
- Post void residual volume ≤ 300cc
- Normal renal function
- Non suspect digital rectal examination
- PSA value et blood test £ 4 ng/ml, or negative prostatic biopsies if PSA comprised between 4 and 10 ng/ml for patients with age < 75 and life expectancy > 10 years
- Patient under oral anticoagulation therapy if a therapeutic switch is possible and validated by both the anaesthesiologist and the prescription of the anticoagulation therapy
- Patient under under antiplatelet agents if this treatment can be interrupted without replacement therapy 5 days prior to surgery without any increased risk for the patient safety
- Patient gave informed consent and is not opposed to the use of the data collected during the study for research purpose
- Patient treated by BPH drugs if the duration and type are known, and if the treatment has been stopped before the intervention (one week before surgery for plants and alpha-blockers, one week for 5-alpha reductase inhibitors)
- Patients has valid health insurance/coverage.
Exclusion Criteria:
- Patients with unstable known cardiac or pulmonary disease
- Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
- Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
- Patient with active urinary tract infection
- Patient with in-place urinary catheter
- Patient with neurogenic disease of the urinary tract
- Patient with known or suspected malignant lesion of the bladder or the prostate
- Patient with history of previous prostatic surgery
- Patient with history of bladder stone, major hematuria, urethral stricture, bladder neck stenosis, bladder disease or diabetes with bladder impairment
- Patient with a prosthesis or material in the region potentially affected by the surgical procedure.
- Patient with ano-rectal disease
- Cases where the surgical indication is decided in an emergency context
- Patient with predictable incomplete follow-up
- Patient with coagulation disease or abnormalities not covered by the drugs belonging to the categories cited in inclusion criteria 11 and 12
- All patient condition that the investigator considers as an exclusion criterion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534793
Contacts
| Contact: Bertrand LUKACS, MD,PhD | +33 (0) 1 56 01 65 00 | bertrand.lukacs@tnn.aphp.fr |
Locations
| France | |
| Service Urologie - Hôpital Tenon | Recruiting |
| Paris, Ile de France, France, 75020 | |
| Principal Investigator: Bertrand LUKACS, MD, PhD | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Bertrand LUKACS, MD,PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01534793 History of Changes |
| Other Study ID Numbers: | K070301 / IC0709, 2008-A-00498-47 |
| Study First Received: | January 25, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Quality assessment Benign Prostatic Hyperplasia Enucleation of the prostate |
LUMENIS Laser Learning Curve |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013