Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04653402
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2020-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006848', 'term': 'Testicular Hydrocele'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open label randomised control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2020-11-28', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin edema', 'timeFrame': 'Post operative period of 1 month', 'description': 'Boggy swelling of scrotal wall'}, {'measure': 'Hematoma', 'timeFrame': 'Post operative period of 1 month', 'description': 'Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site'}, {'measure': 'Surgical site infection', 'timeFrame': 'Post operative period of 1 month', 'description': 'Seropurulent discharge from the incision site with systemic signs of infection like fever, tachycardia and local signs like edema, redness and tenderness'}], 'secondaryOutcomes': [{'measure': 'Testalgia', 'timeFrame': 'post operative period of 1 month', 'description': 'Visual Analog Scale scoring on a 100 mm length scale ( low score with no pain to higher scores with worst imaginable pain) for acute and sub acute testalgia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrocele', 'Drain', 'Surgery', 'Complications', 'Hydrocelectomy', 'Hematoma', 'Infection'], 'conditions': ['Hydrocele of Tunica Vaginalis']}, 'referencesModule': {'references': [{'pmid': '28559772', 'type': 'BACKGROUND', 'citation': 'Dagur G, Gandhi J, Suh Y, Weissbart S, Sheynkin YR, Smith NL, Joshi G, Khan SA. Classifying Hydroceles of the Pelvis and Groin: An Overview of Etiology, Secondary Complications, Evaluation, and Management. Curr Urol. 2017 Apr;10(1):1-14. doi: 10.1159/000447145. Epub 2017 Mar 30.'}, {'pmid': '30552941', 'type': 'BACKGROUND', 'citation': 'Tsai L, Milburn PA, Cecil CL 4th, Lowry PS, Hermans MR. Comparison of Recurrence and Postoperative Complications Between 3 Different Techniques for Surgical Repair of Idiopathic Hydrocele. Urology. 2019 Mar;125:239-242. doi: 10.1016/j.urology.2018.12.004. Epub 2018 Dec 12.'}, {'pmid': '19357743', 'type': 'BACKGROUND', 'citation': 'Agbakwuru EA, Salako AA, Olajide AO, Takure AO, Eziyi AK. Hydrocelectomy under local anaesthesia in a Nigerian adult population. Afr Health Sci. 2008 Sep;8(3):160-2.'}, {'pmid': '26092476', 'type': 'BACKGROUND', 'citation': 'Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.'}, {'pmid': '27689151', 'type': 'RESULT', 'citation': 'Patil V, Shetty SM, Das S. Common and Uncommon Presentation of Fluid within the Scrotal Spaces. Ultrasound Int Open. 2015 Nov;1(2):E34-40. doi: 10.1055/s-0035-1555919. Epub 2015 Nov 6.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/26092476/', 'label': 'Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/19357743/', 'label': 'Hydrocelectomy under local anaesthesia in a Nigerian adult population.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30552941', 'label': 'omparison of Recurrence and Postoperative Complications Between 3 Different Techniques for Surgical Repair of Idiopathic Hydrocele.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/27689151/', 'label': 'Common and Uncommon Presentation of Fluid within the Scrotal Spaces. Ultrasound Int Open'}]}, 'descriptionModule': {'briefSummary': 'There is no clear consensus regarding the benefits of putting a closed suction drain after eversion of the sac in a hydrocele of the tunica vaginalis testis. Our study will find out the benefits if at all of a closed suction drain in hydrocele surgery. The potential complications expected after hydrocelectomy surgery are bleeding, infection, redness, and pain. There is no such trial to date to determine the benefits of putting a closed suction drain after hydrocelectomy surgery.', 'detailedDescription': 'Study objectives:\n\n1. Primary:\n\n To compare the postoperative complication rates of hematoma, skin edema and surgical site infection after hydrocelectomy, between patients with or without a closed suction drain (CSD).\n2. Secondary:\n\nTo compare postoperative pain (testalgia) between the two groups of patients.\n\nStudy setting: All patients over 18 years of age attending the outpatient department of General Surgery at AIIMS, Bhubaneswar with the diagnosis of idiopathic hydrocele and planned for elective surgery.\n\nTotal Sample Size = 60 (30 in each arm)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.\n\nExclusion Criteria:\n\n* Patient not giving consent to participate\n* Patients with ASA (American Society of Anaesthesiology) grade 3 \\& 4\n* Patients with congenital or secondary hydrocele\n* Patients with recurrent disease, pyocele or filarial scrotum'}, 'identificationModule': {'nctId': 'NCT04653402', 'acronym': 'END', 'briefTitle': 'Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences, Bhubaneswar'}, 'officialTitle': 'Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)', 'orgStudyIdInfo': {'id': 'T/IM-NF/Gen.Surg/20/45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm 1', 'description': 'Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele', 'interventionNames': ['Device: Hydrocelectomy surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study arm 2', 'description': 'Not placing a drain after hydrocelectomy in primary vaginal hydrocele', 'interventionNames': ['Device: Hydrocelectomy surgery']}], 'interventions': [{'name': 'Hydrocelectomy surgery', 'type': 'DEVICE', 'description': 'The standardized hydrocelectomy operation i.e. Eversion of the TVT sac', 'armGroupLabels': ['Study arm 1', 'Study arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751019', 'city': 'Bhubaneswar', 'state': 'Odisha', 'country': 'India', 'facility': 'All India institute of medical sciences', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}], 'overallOfficials': [{'name': 'Prakash K. Sasmal, MS,FNB,FAIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'All India Institute of Medical Sciences, Bhubaneswar, INDIA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Before the start of the study', 'ipdSharing': 'YES', 'description': 'Participant information sheet and participant consent form and study protocol.', 'accessCriteria': 'IEC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Bhubaneswar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor,Dept of General Surgery', 'investigatorFullName': 'Dr. Prakash Kumar Sasmal', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Bhubaneswar'}}}}