Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02310958
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2014-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Laparoscopic Inguinal Herniorraphy in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2014-11-30', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inguinal hernia recurrence', 'timeFrame': 'Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months'}], 'secondaryOutcomes': [{'measure': 'postoperative complications (infections)', 'timeFrame': 'Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months'}, {'measure': 'length of hospital stay', 'timeFrame': 'Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months'}, {'measure': 'type of pain medication and duration of use after surgical procedure', 'timeFrame': 'Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months'}, {'measure': 'metachronous hernia occurrence', 'timeFrame': 'Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months', 'description': 'Occurrence of contralateral hernia after operation of unilateral hernia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lapraroscopic surgical procedure', 'infant', 'complications', 'inguinal hernia', 'hernia recurrence'], 'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'American College of Surgeons. Surgical Patient Education. http://www.facs.org/patient education.'}, {'pmid': '9728185', 'type': 'BACKGROUND', 'citation': 'Kapur P, Caty MG, Glick PL. Pediatric hernias and hydroceles. Pediatr Clin North Am. 1998 Aug;45(4):773-89. doi: 10.1016/s0031-3955(05)70044-4.'}, {'pmid': '7447688', 'type': 'BACKGROUND', 'citation': 'Kiesewetter WB, Oh KS. Unilateral inguinal hernias in children: What about the opposite side? Arch Surg. 1980 Dec;115(12):1443-5. doi: 10.1001/archsurg.1980.01380120019005.'}, {'pmid': '10484084', 'type': 'BACKGROUND', 'citation': 'Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, Miller J, Lucas GW, Promes J. Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg. 1999 Sep;65(9):827-31; discussion 831-2.'}, {'pmid': '17353989', 'type': 'BACKGROUND', 'citation': 'Tsai YC, Wu CC, Yang SS. Minilaparoscopic herniorrhaphy with hernia sac transection in children and young adults: a preliminary report. Surg Endosc. 2007 Sep;21(9):1623-5. doi: 10.1007/s00464-007-9207-y. Epub 2007 Mar 13.'}, {'pmid': '18716531', 'type': 'BACKGROUND', 'citation': 'Tsai YC, Wu CC, Yang SS. Is local anesthesia or oral analgesics necessary after mini-laparoscopic functional surgery in children and young adults?: A prospective randomized trial. Surg Laparosc Endosc Percutan Tech. 2008 Aug;18(4):344-7. doi: 10.1097/SLE.0b013e318172ab33.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will be based on a review of hospital records and a questionnaire answered by families. Patient demographics (age, gender), affected side, type and duration of laparoscopic intervention, and outcome parameters (hernia recurrence, post-operative complications, eg. infections, length and type of postoperative pain medication, and length of the postoperative hospital stay) will be analysed.', 'detailedDescription': 'Hernias of the abdominal wall occur if intra-abdominal tissue or peritoneum bulges through the abdominal wall. The most frequent locations of abdominal wall hernia are the inguinal region close to the groin, the umbilicus, and scars. Congenital inguinal hernias occur more frequently in the inguinal region if the vaginal process is not closed adequately at birth. Surgical procedures for correction of inguinal hernias are frequently carried out in children. Laparoscopic procedures to correct inguinal hernias in children are gaining more acceptance. The laparoscopic closure of hernias in children is considered effective and safe and represents an accepted alternative to the open surgical hernia repair. When compared to open surgical hernia repair in children, laparoscopic hernia repair causes smaller scars, allows for a faster postoperative recovery of children, requires less pain medication, and allows for an inspection of the contralateral side, thus facilitating simultaneous hernia repair in the same operation.\n\nWe aim to investigate the short-term results of laparoscopic inguinal hernia repair in children. The main outcome parameter of this single-center study is hernia recurrence or the occurrence of contralateral metachronous hernia. Secondary outcome measures are postoperative complications such as infections of the wound regions, the time between operation and discharge from hospital, and postoperative pain medication requirements. We chose a 4-year time interval for inclusion of patients. Data are retrieved from hospital records in a retrospective evaluation. In addition, a structured questionnaire sent to the families of children will document postoperative complaints and complications from 3 months after the operation onwards. Families not responding to the questionnaire will be offered a structured telephone interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged between 1 day and 16 years who underwent laparoscopic surgical inguinal hernia repair between March 2010 and March 2014 at a single institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 1 day and 16 years who underwent a laparoscopic surgical procedure for correction of unilateral or bilateral inguinal hernia or recurrent inguinal hernia at a single institution\n\nExclusion Criteria:\n\n* age of patient more than 16 years\n* patients suffering from neuromuscular, chronic abdominal, chronic pulmonary, or malignant disorders\n* patients suffering from degenerative soft tissue disorders\n* patients receiving immunosuppressive drugs for more than 3 weeks or during a - 3-week perioperative time interval'}, 'identificationModule': {'nctId': 'NCT02310958', 'briefTitle': 'Outcome of Laparoscopic Inguinal Herniorraphy in Children', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital Basel"}, 'officialTitle': 'A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children', 'orgStudyIdInfo': {'id': 'EKNZ2014-247'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with inguinal hernia', 'description': 'Laparoscopic surgical hernia repair in children aged between 1 day and 16 years', 'interventionNames': ['Procedure: Laparoscopic surgical hernia repair']}], 'interventions': [{'name': 'Laparoscopic surgical hernia repair', 'type': 'PROCEDURE', 'description': 'Laparoscopic surgical hernia repair in children', 'armGroupLabels': ['Children with inguinal hernia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sucharitha Geiger', 'role': 'STUDY_CHAIR', 'affiliation': 'University Childrens Hospital Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Mayr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Johannes Mayr', 'investigatorAffiliation': "University Children's Hospital Basel"}}}}