Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04285502
Status:
UNKNOWN
Last Update Posted:
2020-02-26
First Post:
2020-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PROSPECTIVE RANDOMISED CONTROLLED TRIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-23', 'studyFirstSubmitDate': '2020-02-22', 'studyFirstSubmitQcDate': '2020-02-23', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analgesia need at the post-operative period', 'timeFrame': 'post operative 6. hour', 'description': 'patient need for analgesia during post operative first day'}, {'measure': 'hematocrit levels', 'timeFrame': 'post operative first day', 'description': 'patient hematocrit level at post operative day 1'}, {'measure': 'drainage volume', 'timeFrame': 'post operative first day', 'description': 'drainage volume at postoperative day'}, {'measure': 'post operative infection', 'timeFrame': 'post operative first day and post operative 1. week', 'description': 'manifesting an post operative infection in short term and long term'}, {'measure': 'pain post operative 6.-12. and 24. hour', 'timeFrame': 'pain', 'description': 'will be measured using VAS score'}], 'secondaryOutcomes': [{'measure': 'analgesia need at the post-operative 6. hour', 'timeFrame': 'post-operative 6. hour', 'description': 'patient need for analgesia'}, {'measure': 'analgesia need at the post-operative 12. hour', 'timeFrame': 'post-operative 12. hour', 'description': 'patient need for analgesia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical drain', 'visual analog scale', 'hematocrit'], 'conditions': ['TOTAL ABDOMINAL HYSTERECTOMY']}, 'referencesModule': {'references': [{'pmid': '32044017', 'type': 'RESULT', 'citation': 'Weston M, Soyer P, Barral M, Dohan A, Pierre S, Rabei R, Garcia-Reyes K, Kohi MP. Role of Interventional Procedures in Obstetrics and Gynecology. Radiol Clin North Am. 2020 Mar;58(2):445-462. doi: 10.1016/j.rcl.2019.11.006.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5324450/', 'label': 'Post-Caesarean Drain Placement - Minor Procedure Leading to Major Complication'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4986969/', 'label': 'The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trial'}]}, 'descriptionModule': {'briefSummary': "This prospective randomized controlled trial was planned to be conducted among total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during one year period. The effect of drain insertion during the surgery will be assessed by this clinical trial. Patients will be assigned into two groups as cases and controls. Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Patients will be evaluated according to their post operative VAS scores, hematocrit levels, their drainage volume and manifestation of an infection after the surgery.", 'detailedDescription': "This prospective randomized controlled trial was planned to be conducted from February 2020 to February 2021 and included total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during the study period.\n\nSurgeries on patients with existing comorbidity, with underlying malignant conditions, patients diagnosed deeply infiltrative endometriosis during surgery and patients who undergo multiple surgeries will be excluded from the study.\n\nClinical and descriptive data will be collected from both paper and electronic records, including the pain of the patient, the need for analgesia at the 6th-12th and 24th hour during the post-operative period. Visual analog scale (VAS) will be used to track the pain progression of the patients. Intraabdominal bleeding will be determined by measuring the hematocrit levels and drainage volume at postoperative day 1. Patients will also be assessed according to manifesting an infection in both the short term and long term.\n\nPatients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Data will be analyzed using the Statistical Package for Social Sciences (SPSS). A Chi-squared test will be used to evaluate the significance of the associations between variables. Continuous variables will be displayed as means and standard deviations. A P value of ≤0.050 will be considered as significant.\n\nThis study obtained ethical approval from the Medical Research \\& Ethics Committee of Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* age between 40-70\n* undergoing surgery for a benign condition\n* having an abdominal surgery for the first time\n\nExclusion Criteria:\n\n* existing comorbidity\n* with underlying malignant conditions\n* patients diagnosed deeply infiltrative endometriosis during surgery\n* patients who undergone multiple surgeries'}, 'identificationModule': {'nctId': 'NCT04285502', 'briefTitle': 'Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}, 'officialTitle': 'Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': 'ZEYNEPKAMILHOSPITAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CONTROL GROUP', 'description': 'patients without a drain'}, {'type': 'EXPERIMENTAL', 'label': 'CASE GROUP', 'description': 'Patients a drain inserted', 'interventionNames': ['Procedure: SURGICAL DRAIN']}], 'interventions': [{'name': 'SURGICAL DRAIN', 'type': 'PROCEDURE', 'description': 'A surgical drain is a tube used to remove blood, abscess and any type of fluid at the site of the place it is inserted', 'armGroupLabels': ['CASE GROUP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'enis ozkaya, associated professor', 'role': 'CONTACT', 'email': 'istzeynepkeah.hhak@saglik.gov.tr', 'phone': '216 334 94 00', 'phoneExt': '0090'}], 'facility': 'Zeynep Kamil Maternity and Children Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'enis ozkaya, md', 'role': 'CONTACT', 'email': 'enokaya1979@gmail.com', 'phone': '5054742459', 'phoneExt': '0090'}], 'facility': 'Zeynep Kamil', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOCIATED PROFESSOR', 'investigatorFullName': 'enis ozkaya', 'investigatorAffiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}}}}