Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02319902
Status:
UNKNOWN
Last Update Posted:
2014-12-18
First Post:
2014-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-14', 'studyFirstSubmitDate': '2014-12-14', 'studyFirstSubmitQcDate': '2014-12-14', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder tip pain', 'timeFrame': '8 hours', 'description': 'Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline'}], 'secondaryOutcomes': [{'measure': 'General abdominal pain, nausea, vomiting and analgesia requirements', 'timeFrame': '8 hours', 'description': 'General abdominal pain, nausea, vomiting and analgesia requirements 8 hours post surgery compared to baseline'}, {'measure': 'Shoulder tip pain, general abdominal pain, nausea, vomiting.', 'timeFrame': '7 days', 'description': 'Shoulder tip pain, general abdominal pain, nausea, vomiting over a 7 day period compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.\n* Capacity to consent\n\nExclusion Criteria:\n\n* Patients unable to speak English\n* Patients unable to give consent'}, 'identificationModule': {'nctId': 'NCT02319902', 'briefTitle': 'Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': '14SURN0015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard cold carbon dioxide gas', 'description': 'Standard cold carbon dioxide gas', 'interventionNames': ['Device: Standard cold carbon dioxide gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heated humidified carbon dioxide gas', 'description': 'Heated humidified carbon dioxide gas', 'interventionNames': ['Device: Heated humidified carbon dioxide gas']}], 'interventions': [{'name': 'Standard cold carbon dioxide gas', 'type': 'DEVICE', 'description': 'Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.', 'armGroupLabels': ['Standard cold carbon dioxide gas']}, {'name': 'Heated humidified carbon dioxide gas', 'type': 'DEVICE', 'description': 'Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.', 'armGroupLabels': ['Heated humidified carbon dioxide gas']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Fevzi Shakir, MBBS BSc MRCOG', 'role': 'CONTACT', 'email': 'fevzi@doctors.org.uk'}, {'name': 'Andrew Kent, TD MD FRCOG', 'role': 'CONTACT', 'email': 'kenta@doctors.org.uk'}], 'facility': 'Royal Surrey County Hospital NHS Trust', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'centralContacts': [{'name': 'Fevzi Shakir, MBBS BSc MRCOG', 'role': 'CONTACT', 'email': 'fevzi@doctors.org.uk'}, {'name': 'Andrew Kent, TD MD FRCOG', 'role': 'CONTACT', 'email': 'kenta@doctors.org.uk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fevzi Shakir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Research Fellow in Advanced Gynaecological Laparoscopic Surgery', 'investigatorFullName': 'Fevzi Shakir', 'investigatorAffiliation': 'Royal Surrey County Hospital NHS Foundation Trust'}}}}