Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT05377632
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2022-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Two Different Approaches in Robotic-Assisted Renal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065102', 'term': 'Licensed Practical Nurses'}], 'ancestors': [{'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-05-15', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of the renal artery', 'timeFrame': 'During procedure/surgery', 'description': 'Time from first skin incision to detection of the renal artery \\[Time in minutes\\]'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'During procedure/surgery', 'description': 'The time from \\[Skin Incision\\] to \\[Skin Closure\\] in minutes as documented in OR-Management Information System'}, {'measure': 'Robot docking time', 'timeFrame': 'During procedure/surgery', 'description': 'The time from \\[Skin Incision\\] to \\[robot docking\\] in minutes as documented in OR-Spreadsheet.'}, {'measure': 'Instrument insertion time', 'timeFrame': 'During procedure/surgery', 'description': 'The time from \\[Skin Incision\\] to \\[insertion of the last instrument\\] in minutes as documented in OR-Spreadsheet'}, {'measure': 'Off-console time', 'timeFrame': 'During procedure/surgery', 'description': 'The time from \\[Skin Incision\\] to \\[start of first instrument movement by console surgeon\\] in minutes as documented in OR-Spreadsheet'}, {'measure': 'Ischemia time', 'timeFrame': 'During procedure/surgery', 'description': 'The time from \\[Placement of clamp on artery\\] to \\[Release of clamp\\] in minutes indicated by the console surgeon documented by the anesthesiologist'}, {'measure': 'Surgical conversion to open surgery', 'timeFrame': 'During procedure/surgery', 'description': 'Conversion from robotic to open surgery'}, {'measure': 'Surgical conversion to radical nephrectomy', 'timeFrame': 'During procedure/surgery', 'description': 'Conversion partial to radical nephrectomy'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'During procedure/surgery', 'description': 'Volume of blood loss during the surgical procedure in mL'}, {'measure': 'Console surgeons perception of Trocar placement and working space', 'timeFrame': 'During procedure/surgery', 'description': 'Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)'}, {'measure': 'Side assistants perception of Trocar placement and working space', 'timeFrame': 'During procedure/surgery', 'description': 'Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)'}, {'measure': 'Pain assessment', 'timeFrame': 'During the hospital stay (up to day 7)', 'description': 'Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)'}, {'measure': 'Pain Management', 'timeFrame': 'During the hospital stay (up to day 7)', 'description': 'Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)'}, {'measure': 'Kidney function via the estimated glomerular filtration rate (eGRF)', 'timeFrame': 'During the hospital stay (up to day 7)', 'description': 'Data will be gathered from routine examination, not a mandatory assessment (Lab value read-outs from in the clinical Information System) \\[ml/min/1,73 m2\\]'}, {'measure': 'Post operative complications', 'timeFrame': 'Day 30', 'description': 'Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery'}, {'measure': 'Length of stay Length of stay', 'timeFrame': 'During the hospital stay (up to day 7)', 'description': 'Time from surgery to discharge in days \\[d\\]'}, {'measure': 'Procedure related readmissions', 'timeFrame': 'Day 30', 'description': 'Readmission that can be linked to the (partial) nephrectomy, binary \\[Yes/No\\]'}, {'measure': 'Procedure related reoperations', 'timeFrame': 'Day 30', 'description': 'Re-operation that can be linked to the partial nephrectomy, binary \\[Yes/No\\]'}, {'measure': 'Comprehensive Complication Index', 'timeFrame': 'Day 30', 'description': 'Any complication that occurred within 30 days post surgery, Scale \\[from 0 (no complication) to 100 (death)\\]'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robotic surgery', 'renal tumor'], 'conditions': ['Renal Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.', 'detailedDescription': 'The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed.\n\nThe overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n\nExclusion Criteria:\n\n* Renal vein tumor thrombus\n* Pregnancy or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT05377632', 'acronym': 'PIONEER-OPT', 'briefTitle': 'Comparing Two Different Approaches in Robotic-Assisted Renal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baden'}, 'officialTitle': 'Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PIONEER-OPTICS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hybrid-Group', 'description': 'Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route', 'interventionNames': ['Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retroperitoneal-Group', 'description': 'Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route', 'interventionNames': ['Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)']}], 'interventions': [{'name': 'Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)', 'type': 'PROCEDURE', 'description': 'laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) include bilateral tumors or tumors in a solitary kidney. Relative indications include familial renal cancer syndromes such as Von Hippel-Lindau, hereditary leiomyomatosis, or hereditary papillary renal cell carcinoma. Patients with chronic kidney disease are generally offered nephron sparing surgery for hope of future renal function preservation. This reasoning also applies to those patients with preexisting diseases that may threaten a solitary kidney such as uncontrolled diabetes and hypertension.', 'armGroupLabels': ['Hybrid-Group', 'Retroperitoneal-Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5404', 'city': 'Baden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}], 'overallOfficials': [{'name': 'Lukas J Hefermehl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Baden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that will be recorded in this study will be available on reasonable request from the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lukas J Hefermehl', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kantonsspital Baden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lukas J Hefermehl', 'investigatorAffiliation': 'Kantonsspital Baden'}}}}