Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04960267
Status:
UNKNOWN
Last Update Posted:
2021-07-13
First Post:
2021-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D049291', 'term': 'Seroma'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2021-07-11', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-peritoneal Drainage output after rTAPP', 'timeFrame': 'at 23 hours post-operation', 'description': 'Pre-peritoneal Drainage output (ml) after rTAPP'}], 'secondaryOutcomes': [{'measure': 'Seroma formation', 'timeFrame': 'day 7, 1 month', 'description': 'Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hernia', 'inguinal', 'seroma', 'drain', 'robotic', 'TAPP', 'rTAPP'], 'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'pmid': '29332240', 'type': 'BACKGROUND', 'citation': 'Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Hernia. 2018 Jun;22(3):455-465. doi: 10.1007/s10029-018-1731-2. Epub 2018 Jan 13.'}, {'pmid': '29681017', 'type': 'BACKGROUND', 'citation': 'Li J, Zhang W. Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Hernia. 2018 Jun;22(3):467-468. doi: 10.1007/s10029-018-1762-8. Epub 2018 Apr 21. No abstract available.'}, {'pmid': '29681018', 'type': 'BACKGROUND', 'citation': 'Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Reply to Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomized controlled trial. Hernia. 2018 Jun;22(3):469-470. doi: 10.1007/s10029-018-1764-6. Epub 2018 Apr 21. No abstract available.'}, {'pmid': '25238803', 'type': 'BACKGROUND', 'citation': 'Gao D, Wei S, Zhai C, Chen J, Li M, Gu C, Wu H. Clinical research of preperitoneal drainage after endoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2015 Oct;19(5):789-94. doi: 10.1007/s10029-014-1310-0. Epub 2014 Sep 20.'}, {'pmid': '27889845', 'type': 'BACKGROUND', 'citation': 'Fan JKM, Yip J, Foo DCC, Lo OSH, Law WL. Randomized trial comparing self gripping semi re-absorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty: the 6 years result. Hernia. 2017 Feb;21(1):9-16. doi: 10.1007/s10029-016-1545-z. Epub 2016 Nov 26.'}, {'pmid': '32072340', 'type': 'RESULT', 'citation': 'Liu JW, Chen KJ, Xu XH, Deng Y, Zhang H, Chan FSY, Kim HJ, Fan JKM. Does the use of monopolar energy as the preferred mode of dissection effectively reduce seroma formation in laparoscopic total extra peritoneal hernioplasty? A prospective double-blinded randomized control trial. Hernia. 2020 Aug;24(4):821-829. doi: 10.1007/s10029-020-02136-3. Epub 2020 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.', 'detailedDescription': 'The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.\n\nCriteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for GA for minimally invasive hernia repair. Routine robotic TAPP performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. Drain output, pain scores, status of seroma formation (clinical, USG detected), post-operative recovery and recurrence will be monitored and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral,\n* First occurrence\n* Reducible inguinal hernia\n\nExclusion Criteria:\n\n* Not fit for GA,\n* Bilateral hernia\n* Recurrent hernia\n* Irreducible hernia\n* Inguino-scrotal extension hernia\n* Non-inguinal hernia'}, 'identificationModule': {'nctId': 'NCT04960267', 'acronym': 'DrainrTAPP', 'briefTitle': 'Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP', 'orgStudyIdInfo': {'id': 'HERN-rTAPPDRAIN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of pre-peritoneal drainage after rTAPP', 'description': 'Use of pre-peritoneal drainage after rTAPP\n\nOutcomes will be compared with retrospective cohort from our previous experiments', 'interventionNames': ['Device: Use of pre-peritoneal drainage after rTAPP']}], 'interventions': [{'name': 'Use of pre-peritoneal drainage after rTAPP', 'type': 'DEVICE', 'description': 'Use of pre-peritoneal drainage after rTAPP', 'armGroupLabels': ['Use of pre-peritoneal drainage after rTAPP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Joe KM Fan, MBBS,MS,FRCS', 'role': 'CONTACT', 'email': 'drjoefan@hku.hk', 'phone': '+86-18307555114'}, {'name': 'JW Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'XF Yang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'KJ Chen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Surgery, The University of Hong Kong - Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Joe KM FAN, MBBS MS(HKU)', 'role': 'CONTACT', 'email': 'drjoefan@hku.hk', 'phone': '+86-86913388'}], 'overallOfficials': [{'name': 'Joe KM FAN, MBBS MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong-Shenzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Dr. Joe King-Man Fan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}