QUAPELLA (QUAlity of Prostate Enucleation by LUMENIS - Laser)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01534793
First received: January 25, 2012
Last updated: November 12, 2013
Last verified: November 2013
  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
    • hemostasis
    • 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: May 2014
Primary Completion Date: May 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:

  1. Male patients over 50
  2. Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
  3. Protocol accepted by patient (signed informed consent)
  4. 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, or full bladder retention, drained by a catheter or suprapubic catheter
  5. Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry, for patients who are not drained
  6. Prostate weight between 40 and 80 grams
  7. Post void residual volume ≤ 300cc, for patients who are not drained
  8. Normal renal function
  9. Non suspect digital rectal examination
  10. 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
  11. Patient under oral anticoagulation therapy if a therapeutic switch is possible and validated by both the anaesthesiologist and the prescription of the anticoagulation therapy
  12. 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
  13. Patient gave informed consent and is not opposed to the use of the data collected during the study for research purpose
  14. 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)
  15. Patients has valid health insurance/coverage.

Exclusion Criteria:

  1. Patients with unstable known cardiac or pulmonary disease
  2. Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
  3. Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
  4. Patient with active urinary tract infection
  5. Patient with urinary catheter or a suprapubic catheter for a reason other than acute urinary retention due to benign prostatic hyperplasia or experiencing no need to urinate after an event filling than 300cc
  6. Patient with neurogenic disease of the urinary tract
  7. Patient with known or suspected malignant lesion of the bladder or the prostate
  8. Patient with history of previous prostatic surgery
  9. Patient with history of bladder stone, major hematuria, urethral stricture, bladder neck stenosis, bladder disease or diabetes with bladder impairment
  10. Patient with a prosthesis or material in the region potentially affected by the surgical procedure.
  11. Patient with ano-rectal disease
  12. Cases where the surgical indication is decided in an emergency context
  13. Patient with predictable incomplete follow-up
  14. Patient with coagulation disease or abnormalities not covered by the drugs belonging to the categories cited in inclusion criteria 11 and 12
  15. All patient condition that the investigator considers as an exclusion criterion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534793

Locations
France
Service Urologie - Hôpital Tenon
Paris, Ile de France, France, 75020
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: November 12, 2013
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:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 01, 2014