Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT05330156
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2022-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of operation', 'timeFrame': 'intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)', 'description': 'time used for resection or enucleation and resection of the prostate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BPH']}, 'descriptionModule': {'briefSummary': 'TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator.', 'detailedDescription': 'Transurethral resection of the prostate (TURP) was first done in the 1920s. Since then, TURP has been considered as the gold standard treatment for BPH . However, its relatively high complication rate and postoperative recurrence necessitates further modification in the surgery technique .The resected adenomas have been reported to recur in up to 15% of cases that need a repeat surgical intervention, even by experienced surgeons in high-volume centers .\n\nBefore the era of TURP, simple open prostatectomy was the mainstay of surgical therapy. However, open simple prostatectomy has high risk of considerable intraoperative bleeding requiring transfusion. The lower abdominal incision done in open prostatectomy may result in significant postoperative pain, an extended recovery period and longer hospital stay, with greater morbidity and a perioperative mortality rate of 0.2%. In addition, TURP for large prostatic adenomas causes significantly much more bleeding with clot retention as compared to simple open prostatectomy, it also need a longer operative time, which leads to increased risk of TUR syndrome with subsequent morbidity . A new technique in which transurethral enucleation and resection of the prostate (TUERP) was developed and adopted to replicate the open enucleation of prostatic adenomas in an endoscopic way. This will combine the benefits of complete prostate enucleation in a minimally invasive technique . prostate enucleation by laser currently used as minimally invasive and save alternative to TURP, but still has not been widely accepted for some reasons, including high cost and prolonged learning curve.\n\nTUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'BPH disease is a male disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Patients aging from 50 to 80 years old who are diagnosed with clinical symptomatic BPH.\n* The patients have clear indi¬cation for endoscopic surgery (according to the guidelines).\n* Clinically fit patients for surgery.\n* Signed an informed consent.\n\nExclusion Criteria:\n\n* Prostate cancer Previous urethral or prostate surgery Neurogenic bladder Urethral stricture Poor general condition of the patient'}, 'identificationModule': {'nctId': 'NCT05330156', 'acronym': 'Prostate', 'briefTitle': 'Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'TURP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transurethral resection of the prostate group (TURP).', 'description': 'the 1st group of patients will undergone Transurethral resection of the prostate for treatment of BPH', 'interventionNames': ['Procedure: Transurethral resection of the prostate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transurethral enucleation of prostate group (TUEP)', 'description': 'the 2nd group of patients will undergone Transurethral enucleation of the prostate for treatment of BPH', 'interventionNames': ['Procedure: transurethral enucleation of prostate']}], 'interventions': [{'name': 'Transurethral resection of the prostate', 'type': 'PROCEDURE', 'description': '\\- After an initial cysto-urethroscopy assessment done, Transurethral resection of the prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.', 'armGroupLabels': ['Transurethral resection of the prostate group (TURP).']}, {'name': 'transurethral enucleation of prostate', 'type': 'PROCEDURE', 'description': 'After an initial cysto-urethroscopy assessment done, transurethral enucleation of prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.', 'armGroupLabels': ['transurethral enucleation of prostate group (TUEP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71715', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed F Hassan, Master', 'role': 'CONTACT', 'email': 'ahmedfarahat358@gmail.com', 'phone': '01069569946'}, {'name': 'AHMED F HASSAN', 'role': 'CONTACT', 'email': 'ahmedfarahat358@gmail.com', 'phone': '01156522620'}], 'overallOfficials': [{'name': 'MOHAMED F ABBAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'AHMED FARAHAT HASSAN', 'investigatorAffiliation': 'Assiut University'}}}}