Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 4:44 AM
Study NCT ID:
NCT04949659
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low vs Medium Pressure Pneumoperitoneum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score on postoperative day one (abdominal pain)', 'timeFrame': 'Postoperative day one.', 'description': 'Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain scores during postoperative phase (abdominal pain)', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'Postoperative pain score for abdominal pain on further postoperative days (excluding day one, which is primary outcome) after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.'}, {'measure': 'Postoperative pain scores during postoperative phase (shoulder pain)', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'Postoperative pain score for shoulder pain during hospitalisation after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.'}, {'measure': 'Length of operation', 'timeFrame': 'Intraoperative', 'description': 'Length of operation in minutes'}, {'measure': 'Length of stay', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'Length of stay in hospital in hours'}, {'measure': 'Intra- and postoperative complications', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'Intra- and postoperative complications during hospitalisation'}, {'measure': 'Analgesic use', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumoperitoneum', 'Pressure', 'Pain'], 'conditions': ['Appendicitis Acute']}, 'referencesModule': {'references': [{'pmid': '24639018', 'type': 'BACKGROUND', 'citation': 'Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.'}, {'pmid': '26275545', 'type': 'BACKGROUND', 'citation': 'Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.'}, {'pmid': '18562251', 'type': 'BACKGROUND', 'citation': 'McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prepped and consented for diagnostic laparoscopy for likely acute appendicitis\n* 5 years or older\n* 15 kg or more\n* Parents/legal custodian give consent, patient shows no signs of unwillingness to participate\n* Patient is hemodynamically stable\n\nExclusion Criteria:\n\n* Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis\n* Suspected perityphlitic abscess on preoperative ultrasound\n* Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties\n* Parents have inadequate knowledge of German language to understand Informed consent\n* Child has inadequate knowledge of German language to allow elicitation of Pain Scores'}, 'identificationModule': {'nctId': 'NCT04949659', 'acronym': 'LoMePneu', 'briefTitle': 'Low vs Medium Pressure Pneumoperitoneum', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery', 'orgStudyIdInfo': {'id': '1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low pressure pneumoperitoneum', 'description': 'Use of low pressure pneumoperitoneum during laparoscopic appendectomy', 'interventionNames': ['Procedure: Laparoscopic appendectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Medium pressure pneumoperitoneum', 'description': 'Use of medium pressure pneumoperitoneum during laparoscopic appendectomy', 'interventionNames': ['Procedure: Laparoscopic appendectomy']}], 'interventions': [{'name': 'Laparoscopic appendectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum', 'armGroupLabels': ['Low pressure pneumoperitoneum', 'Medium pressure pneumoperitoneum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Hannah R Neeser', 'role': 'CONTACT', 'email': 'hannah.neeser@kispi.uzh.ch', 'phone': '+41442667111'}], 'facility': "University Children's Hospital Zurich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Hannah R Neeser, MD', 'role': 'CONTACT', 'email': 'Hannah.Neeser@kispi.uzh.ch', 'phone': '+41442667045'}, {'name': 'Ueli Moehrlen, MD', 'role': 'CONTACT', 'email': 'Ueli.moehrlen@kispi.uzh.ch', 'phone': '+41442667407'}], 'overallOfficials': [{'name': 'Hannah R Neeser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital of Zurich"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}