Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-31 @ 9:20 AM
Study NCT ID:
NCT07014969
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
En-bloc With Early Apical Release Versus Lobe-by-lobe LASER Enucleation of the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D001748', 'term': 'Urinary Bladder Neck Obstruction'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enucleation efficiency', 'timeFrame': 'perioperative/ periprocedural', 'description': 'resected prostate weight divided by enucleation time'}, {'measure': 'enucleation speed', 'timeFrame': 'perioperative/ periprocedural', 'description': 'time between insertion. of laser fiber till complete detachment of the adenoma'}], 'secondaryOutcomes': [{'measure': 'Resected prostate weight', 'timeFrame': 'perioperative/ periprocedural', 'description': 'Weight of resected prostatic tissue expressed in Grams'}, {'measure': 'Incidence of early urinary incontinence', 'timeFrame': '1,3 and 6 months', 'description': 'assessment of incidence of early urge and stress urinary incontinence.'}, {'measure': 'morcellation efficiency', 'timeFrame': 'perioperative/ periprocedural', 'description': 'Weight of resected prostate tissue in grams morcellated per minute expressed in (grams per minute)'}, {'measure': 'length of hospital stay', 'timeFrame': 'perioperative/ periprocedural', 'description': 'lenght of hospital admission measure in days'}, {'measure': 'total laser energy', 'timeFrame': 'perioperative/ periprocedural', 'description': 'Total Laser energy required expressed in Joules'}, {'measure': 'LASER/Prostate ratio', 'timeFrame': 'perioperative/ periprocedural', 'description': 'Laser energy required to resect one gram of prostatic tissue expressed in (kiloJoule per gram)'}, {'measure': 'volume of intraoperative irrigation', 'timeFrame': 'perioperative/ periprocedural', 'description': 'volume of irrigation saline volume expressed in Litres'}, {'measure': 'perioperative blood loss', 'timeFrame': 'perioperative/ periprocedural', 'description': 'haemoglobin deficit measured by the difference between preopeartive and postoperative hemoglobin expressed in Gm/dl'}, {'measure': 'catheterization time', 'timeFrame': 'perioperative/ periprocedural', 'description': 'time to catheter removal expressed in Days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Prostate Hyperplasia', 'Bladder Outlet Obstruction']}, 'descriptionModule': {'briefSummary': 'Since its introduction in 1998 , and through numerous level 1a evidence, Holmium Laser enucleation of the prostate (HoLEP) has come to be considered a size-independent golden standard treatment for management of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH) endorse by all guidelines.\n\nFurthermore, Holep, together with minimaly invasive simple prostatectomy, is considered the most accepted alternative to Open simple protatectomy for prostates larger than 80ml.\n\nDespite being the most thoroughly investigated laser technique with enduring efficacy and low morbidity, HoLEP remains restricted to relatively few centers mostly due to the long flat learning curve and lack of access to mentorship programs . On the other hand, the prevalence of stress urinary incontinence following HoLEP was reported to be about (3.3%-26% ) To overcome these difficulties hindering the wide-spread adoption of HoLEP, several modifications of the original three-lobe technique have been described to improve surgical outcomes and overcome the learning difficulties .\n\nOne of the newer modifications for AEEP that have shown promising results is the en-bloc enucleation with early apical release developed by Sancha et al in 2015 utilizing Green Light LASER which has the potential advantage of preserving the integrity of the external sphincter . The same principles of early apical liberation and sphincter mucosal preservation have been applied to lobe by lobe techniques as well.\n\nIn this work the investigators aim to obtain high level evidence of efficacy of En-bloc HoLEP and its impact on early recovery of continence in comparison to the conventional lobe-by-lobe (LBL) HoLEP.', 'detailedDescription': "Benign prostatic hyperplasia (BPH) is one of the most commonly diagnosed conditions of the male genitourinary tract worldwide, resulting in approximately 1.2 million surgical procedures per year. Holmium laser enucleation of the prostate (HoLEP) has proven to be an efficient, durable, and safe surgical option for the management of BPH. The European Association of Urology (EAU) Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS) in 2016 considered HoLEP (referred to as endoscopic enucleation of the prostate, EEP) as a reference technique for the management of large prostates.\n\nThe evolution of laser technology has revived the concept of anatomical enucleation, allowing the resectoscope to be used to dissect the adenoma from the surgical capsule, mimicking the surgeon's index finger in open prostatectomy. This concept of laser-assisted anatomical enucleation can be efficiently replicated by other types of laser energy apart from Holmium.\n\nHoLEP was first described in 1998 as a three-lobe technique, involving the creation of two incisions at the bladder neck, then joining these incisions in front of the verumontanum before enucleating the median, left, and right lobes sequentially but its dissemination has been limited by a steep learning curve and relative procedural difficulty, especially in large glands as well as high rate of trasnient stress urinary incontinence.\n\nMore recently, 'en bloc' techniques have been introduced, which may offer advantages such as better visualization, faster identification of the surgical capsule and dissection plane, early release and better preservation of the sphincter, and an improved learning curve compared to the three-lobe technique.\n\nOne such en-bloc method involves identifying the correct plane between adenoma and capsule at the apex of the left lobe lateral to the verumontanum, extending the incision retrogradely towards the bladder, and using the endoscope to gently raise the lobe from the capsular plane, gradually exposing the dissection plane and reducing intraoperative difficulties such as bleeding and capsule perforation, while shortening enucleation time.\n\nFeasibility studies of en-bloc HoLEP on patients with moderately enlarged prostates showed promising operative times and significant reductions in prostate-specific antigen (PSA) and transition zone volume, indicating effective adenoma removal.\n\nComparative studies between en-bloc HoLEP and traditional two- or three-lobe techniques have reported shorter enucleation times and lower laser energy use with the en-bloc approach.\n\nLarge randomized trials have similarly found that en-bloc HoLEP is associated with significantly shorter operative and enucleation times compared to the three-lobe technique.\n\nAim of the work\n\nGrowing evidence suggests that en-bloc enucleation of the prostatic adenoma, which involves dissection of the adenoma as a single tissue mass, offers advantages over the usual two- or three-lobe techniques: shortened operation time, optimal visualization of the dissection plane due to reduced bleeding and excellent irrigation, and improved enucleation effectiveness.\n\nEarly demarcation of the 'white line' leading to early release of the sphincter from the prostatic apex could reduce the likelihood of transient postoperative stress urinary incontinence. This is because the sphincter is less likely to be stretched during dissection movements, which can otherwise occur when the external sphincter is fixed on one side and the scope is dissecting on the opposite side.\n\nIn this study, the investigators aim to provide high-level evidence on the feasibility and efficacy of en-bloc enucleation using holmium lasers and its impact on early continence recovery. The investigators will conduct a well-designed randomized controlled trial comparing en-bloc endoscopic laser enucleation versus the conventional two- or three-lobe technique."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients' age ≥ 40 years\n2. LUTS secondary to BOO due to BPH who failed medical treatment\n3. International prostate symptom scores (IPSS) \\>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)\n4. Peak urinary flow rate (Qmax) \\<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.\n5. ASA (American society of anaesthesiologists) score ≤3.\n6. TRUS prostate size 80-200 ml\n\nExclusion Criteria:\n\n1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease\n2. Active urinary tract infection,\n3. Presence of active bladder cancer.\n4. Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.\n5. Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.\n6. Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).\n7. Patient has had an acute myocardial infarction or open-heart surgery \\<180 days prior to the date of informed consent. -"}, 'identificationModule': {'nctId': 'NCT07014969', 'briefTitle': 'En-bloc With Early Apical Release Versus Lobe-by-lobe LASER Enucleation of the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'En-bloc Versus Lobe-by-lobe Holmium Laser Enucleation of the Prostate (HoLEP): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS.21.07.1561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'En-bloc HoLEP', 'description': "1. An inverted U-shaped incision in front of the veru montanum followed by extension of the incision laterally on both lateral lobes\n2. Using the peak of the scope, blunt enucleation of the lateral lobes\n3. Enucleation continued laterally with insinuation of the scope lateral to the enucleated lobe on both sides, ending by residual mucosal attachment of the adenoma to the sphincter between 11 and 1 O'clock positions\n4. Release of the adenoma from the sphincter is done by transverse cutting of the mucosal attachment using 180 degree inverted scope the fiber position at 12 O'clock position of the scope\n5. the enucleation process continued above the adenoma from side to side both bluntly and laser assisted till reaching the bladder neck\n6. lateral dissection of the ad enoma will be carried out on both sides\n7. Finally basal dissection of the adenoma and flipping of the both adenomas as one chunk to the bladder followed by laser cutting of any residual attachment.", 'interventionNames': ['Procedure: En-bloc HoLEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lobe by Lobe HoLEP', 'description': 'classic 2 or 3 lobe technique with early apical release', 'interventionNames': ['Procedure: En-bloc HoLEP']}], 'interventions': [{'name': 'En-bloc HoLEP', 'type': 'PROCEDURE', 'description': 'Removal of the whole adenoma in one piece using laser energy', 'armGroupLabels': ['En-bloc HoLEP', 'Lobe by Lobe HoLEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Outside U.S./Canada', 'country': 'Egypt', 'facility': 'Urology and nephrology center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed El-Assmy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yahya Hossam', 'investigatorAffiliation': 'Mansoura University'}}}}