Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
Study NCT ID:
NCT06543095
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2024-08-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rib Removal and Pain in Partial Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-03', 'studyFirstSubmitDate': '2024-08-03', 'studyFirstSubmitQcDate': '2024-08-03', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain level', 'timeFrame': 'days 0, 1, and 3 and week 3', 'description': 'Primary outcome of the study was to compare the pain intensities of the two groups at postoperative days 0, 1, and 3 and week 3 and to evaluate the additional pain burden induced by the rib removal procedure.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Postoperative 7 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rib Removal', 'Partial nephrectomy', 'pain', 'renal cancer'], 'conditions': ['Pain', 'Partial Nephrectomy', 'Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'In this study, the effect of rib removal on postoperative pain in kidney cancer patients undergoing retroperitoneal open partial nephrectomy with flank incision was investigated. For this purpose, VAS score surveys were prepared for patients who underwent partial nephrectomy surgery in the early and late postoperative periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent open partial nephrectomy with flank incision between July 2022 and October 2023 in our clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years who underwent open renal surgery due to kidney cancer were included in the study.\n\nExclusion Criteria:\n\n* Patients with a preoperative (one day before surgery) VAS score greater than 0,\n* Those with additional known diseases that could cause pain (herniated disc, urinary stone disease, inflammatory bowel diseases, other intra-abdominal pathologies),\n* Intraoperative complications that could cause postoperative pain, metastasis, positive surgical margins or peri-renal invasion,\n* Those who underwent laparoscopic surgery or those who converted to open surgery after laparoscopic surgery,\n* Patients that regularly used painkillers for other reasons,\n* Patients whose ribs other than the 11th rib were removed were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06543095', 'briefTitle': 'Rib Removal and Pain in Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Rib Removal in Retroperitoneal Open Partial Nephrectomy: Not As Painful As It Seems', 'orgStudyIdInfo': {'id': '2022/589'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'who underwent rib removal during the partial nephrectomy', 'interventionNames': ['Other: Pain level']}, {'label': 'Group 2', 'description': "who didn't underwent rib removal during the partial nephrectomy", 'interventionNames': ['Other: Pain level']}], 'interventions': [{'name': 'Pain level', 'type': 'OTHER', 'description': 'Post-operative pain levels of the patients with detected using VAS score.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38080', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data available on request from the authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Gokhan Sonmez', 'investigatorAffiliation': 'TC Erciyes University'}}}}