Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01259258
Status:
COMPLETED
Last Update Posted:
2010-12-14
First Post:
2010-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014646', 'term': 'Varicocele'}, {'id': 'D006848', 'term': 'Testicular Hydrocele'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-13', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complication', 'timeFrame': '30 days', 'description': 'hydrocele'}], 'secondaryOutcomes': [{'measure': 'recurrence, pregnancy, semen parameter', 'timeFrame': 'one year', 'description': 'recurrence, pregnancy, semen parameter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['varicocele, methylene blue, varicocelectomy, hydrocele,'], 'conditions': ['Varicocele']}, 'referencesModule': {'references': [{'pmid': '15533495', 'type': 'BACKGROUND', 'citation': 'Ghanem H, Anis T, El-Nashar A, Shamloul R. Subinguinal microvaricocelectomy versus retroperitoneal varicocelectomy: comparative study of complications and surgical outcome. Urology. 2004 Nov;64(5):1005-9. doi: 10.1016/j.urology.2004.06.060.'}, {'pmid': '16566968', 'type': 'BACKGROUND', 'citation': 'Zini A, Fischer A, Bellack D, Noss M, Kamal K, Chow V, Mak V. Technical modification of microsurgical varicocelectomy can reduce operating time. Urology. 2006 Apr;67(4):803-6. doi: 10.1016/j.urology.2005.10.044. Epub 2006 Mar 29.'}, {'pmid': '16469616', 'type': 'BACKGROUND', 'citation': 'Schwentner C, Oswald J, Lunacek A, Deibl M, Bartsch G, Radmayr C. Optimizing the outcome of microsurgical subinguinal varicocelectomy using isosulfan blue: a prospective randomized trial. J Urol. 2006 Mar;175(3 Pt 1):1049-52. doi: 10.1016/S0022-5347(05)00410-6.'}, {'pmid': '17656230', 'type': 'BACKGROUND', 'citation': 'Atteya A, Amer M, AbdelHady A, Al-Azzizi H, Ismael E, Abdel-Gabbar M, Shamloul R. Lymphatic vessel hydrodissection during varicocelectomy. Urology. 2007 Jul;70(1):165-7. doi: 10.1016/j.urology.2007.04.012.'}, {'pmid': '21875697', 'type': 'DERIVED', 'citation': 'Abd Ellatif ME, El Nakeeb A, Shoma AM, Abbas AE, Askar W, Noman N. Dye assisted lymphatic sparing subinguinal varicocelectomy. A prospective randomized study. Int J Surg. 2011;9(8):626-31. doi: 10.1016/j.ijsu.2011.07.430. Epub 2011 Aug 23.'}], 'seeAlsoLinks': [{'url': 'http://www.mans.edu.eg/', 'label': 'mansoura university'}]}, 'descriptionModule': {'briefSummary': 'We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months.', 'detailedDescription': 'Methods. We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months.\n\nResults: There were no intraoperative complications in either group. There were no adverse reactions, scrotal haematomas or atrophy. In group 1, no patient had a hydrocele at 3 months after surgery. By contrast, in group 2 (surgery alone) there were four cases of secondary hydrocele (10%; P=0.025)); no testicular hypertrophy was observed following lymphatic sparing surgery , One patient in each group had varicocele recurrence. Pregnancy was reported in 30 patients (37.5%) during a follow up period, 17 of them (42.5%) were group(1),P \\>0.34. difference was not significantly different among the two groups'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all left sided varicocele with impaired sperm counts, testicular pain and/or testicular atrophy\n\nExclusion Criteria:\n\n* were preexisting hydrocele, previous groin surgery, concomitant hernia, allergy against methylene blue'}, 'identificationModule': {'nctId': 'NCT01259258', 'acronym': 'varicocele', 'briefTitle': 'Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Dye Assisted Lymphatic Sparing Varicocelectomy,Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'varicocele'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'varicocelectomy with dye', 'description': 'subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation', 'interventionNames': ['Procedure: without dye varicocelectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'without dye varicocelectomy', 'description': '40 controls in whom no mapping technique was adopted in the period between', 'interventionNames': ['Procedure: without dye varicocelectomy']}], 'interventions': [{'name': 'without dye varicocelectomy', 'type': 'PROCEDURE', 'otherNames': ['optical subinguinal varicocelectomy'], 'description': '40 controls in whom no mapping technique was adopted in the period between', 'armGroupLabels': ['varicocelectomy with dye']}, {'name': 'without dye varicocelectomy', 'type': 'PROCEDURE', 'otherNames': ['microoptic subinguinal varicocelectomy'], 'description': '40 controls in whom no mapping technique was adopted in the period between', 'armGroupLabels': ['without dye varicocelectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'ayman elnakeeb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'mohamed el ayed', 'oldOrganization': 'masoura university'}}}}