Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-04 @ 8:07 PM
Study NCT ID:
NCT06734494
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of analgesics', 'timeFrame': 'From the end of surgery to the discharge home, up to 20 days', 'description': 'Number of medications taken during hospitalization'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'From the admission to the discharge home, up to 20 days', 'description': 'Length of stay'}, {'measure': 'Operating Time', 'timeFrame': 'From beginning to end of surgery', 'description': 'Time to operate the patients'}, {'measure': 'Mean Digital Pain Scale', 'timeFrame': 'Immediately after surgery until discharge home, up to 20 days', 'description': 'Digital Pain Scale: minimum is 0 out of 10 (which means no pain) and maximum is 10 out of 10 (which means very painful). Higher scores mean worse outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Valveless Trocar', 'Low-pressure Insufflation', 'Standard insufflation', 'Laparoscopic Appendectomy', 'Appendicular Peritonitis', 'Retrospective Study'], 'conditions': ['Peritonitis; Acute', 'Acute Appendicitis', 'Postoperative Pain', 'Laparoscopy']}, 'referencesModule': {'references': [{'pmid': '24503370', 'type': 'BACKGROUND', 'citation': 'Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.'}, {'pmid': '21457071', 'type': 'BACKGROUND', 'citation': 'Rebuck DA, Zhao LC, Helfand BT, Casey JT, Navai N, Perry KT, Nadler RB. Simple modifications in operating room processes to reduce the times and costs associated with robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jun;25(6):955-60. doi: 10.1089/end.2010.0534. Epub 2011 Apr 2.'}, {'pmid': '30159821', 'type': 'BACKGROUND', 'citation': "de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29."}]}, 'descriptionModule': {'briefSummary': 'The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures. The investigators would like to know if these allegations also apply to children.', 'detailedDescription': 'From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had an appendicular peritonitis treated by laparoscopic appendectomy. The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard insufflation. On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew which type of insufflation was used. On the other hand, the patient, his parents and the nurses in the pediatric department did not know which type of insufflation was used. The participants were divided in two groups: the Airseal group (A) and the standard group (S). In each group, the investigators studied and compared the postoperative pain, the consumption of analgesics, the operating time, and the length of stay for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged between 4 and 17 years old who underwent laparoscopic appendectomy for appendicular peritonitis using the Airseal® or a Standard Insufflation, from 2022/01/1st to 2022/12/31st.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 4 and 17 years old\n* Who underwent laparoscopic appendectomy for appendicular peritonitis\n* Between 2022/06/1st and 2022/12/31st\n\nExclusion Criteria:\n\n* Children younger than 4 years old or older than 18 years old\n* Who did not have appendicular peritonitis\n* Between 2022/01/1st and 2022/12/31st'}, 'identificationModule': {'nctId': 'NCT06734494', 'acronym': 'APPAS', 'briefTitle': 'Retrospective Comparison Between AirSeal® and Standard Insufflation in Appendicular Peritonitis', 'nctIdAliases': ['NCT05840419'], 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Laparoscopic Appendectomy Using Airseal or a Standard Insufflator for Peritonitis in Children', 'orgStudyIdInfo': {'id': 'M24DC1108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Airseal group (A)', 'description': 'Patients who underwent a laparoscopic appendectomy using Airseal', 'interventionNames': ['Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation']}, {'label': 'Standard group (S)', 'description': 'Patients who underwent a laparoscopic appendectomy using standard insufflation', 'interventionNames': ['Device: Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation']}], 'interventions': [{'name': 'Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation', 'type': 'DEVICE', 'description': 'Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device.', 'armGroupLabels': ['Airseal group (A)', 'Standard group (S)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'University Hospital, Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "In the name of anonymization we won't share individual participant data"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Destinval Christelle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Destinval Christelle', 'investigatorAffiliation': 'University Hospital, Clermont-Ferrand'}}}}