[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658461":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":62,"studyPopulation":55,"armGroups":63,"interventions":76,"overallOfficials":86,"centralContacts":90,"locations":96,"responsibleParty":127,"collaborators":131,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":55,"enrollmentInfo":147,"targetDuration":55,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":169,"whyStopped":55,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":55},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Brief Pain Inventory (BPI) pain severity score from baseline to postoperative day","Pain severity will be assessed using the Brief Pain Inventory. The scale measures the patients subjective assessment of pain on 15 different items. The scale ranges from 0 to 10, where 0 indicates no pain, and 10 indicates worst thinkable pain. The outcome measure will be calculated as the change from baseline to postoperative day 1 using the mean score of items 3-6.","First post operative day",{"measure":14,"description":15,"timeFrame":16},"Intraoperative blood loss during robot-assisted partial nephrectomy","Blood loss will be measured intraoperatively in milliliters and compared between early and standard renal artery declamping strategies.","Day of Surgery",[18,22,26,30,33,37,41,45,49,52],{"measure":19,"description":20,"timeFrame":21},"Total opioid consumption during the first 24 postoperative hours","Opioid administration will be converted to oral morphine equivalents and summed over the first 24 hours after surgery.","First postoperative day",{"measure":23,"description":24,"timeFrame":25},"Change in Quality of Recovery-15 Norwegian version (QoR-15NO) score","Recovery will be assessed using Quality of recovery 15, Norwegian version (QoR-15NO). The scale measures recovery after surgery on a 15 item scale ranging from 0 to 10 where 0 is worst possible recovery, and 10 is best possible recovery. The outcome measure will be the change from baseline to postoperative day 1, at 6 weeks, and 1 year after surgery.","Baseline, first postoperative day, 6 weeks and 1 year after surgery",{"measure":27,"description":28,"timeFrame":29},"Change in the European Organisation for Research and Treatment of Cancer quality of life 30 (EORTC QLQ 30)","Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer quality of life 30 (EORTC QLQ 30) questionnaire. The scale measures quality of life on a 30 item scale on a range of 1 to 4 ( 1 to seven regarding items 29 and 30), where 1 is best quality of life, and 4 is worst.","Baseline, 6 weeks and 1 year after surgery",{"measure":31,"description":32,"timeFrame":16},"Warm ischemia time during robot-assisted partial nephrectomy","Warm ischemia time will be measured in minutes from application to removal of the renal artery clamp.",{"measure":34,"description":35,"timeFrame":36},"Incidence of postoperative complications","Complications will be graded according to the Clavien-Dindo classification.","30 and 90 days after surgery",{"measure":38,"description":39,"timeFrame":40},"Length of stay after surgery","Measured as the number of days between surgery and discharge.","Between surgery and discharge, average 2 days",{"measure":42,"description":43,"timeFrame":44},"Change in estimated glomerular filtration rate (eGFR)","Renal function will be assessed by comparing postoperative eGFR with baseline values.","Baseline, first post operative day, 6 weeks, 1, 3 and 5 years after surgery.",{"measure":46,"description":47,"timeFrame":48},"Recurrence-free survival","Time from surgery to radiologically or pathologically confirmed recurrence","Up to 5 Years",{"measure":50,"description":51,"timeFrame":48},"Disease-Specific Survival","Time from surgery to death attributable to renal cancer.",{"measure":53,"description":54,"timeFrame":48},"Overall survival","Time from surgery to death from any cause.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":61,"maskingDescription":55,"whoMasked":55},"NONE","Renal cell carcinoma can be managed with surgical excision, surveillance, or ablative techniques. For localized renal tumors, robot-assisted partial nephrectomy (RAPN) has become a standard treatment because it preserves renal function while maintaining oncological outcomes comparable to radical nephrectomy. Two minimally invasive surgical approaches are commonly used for RAPN: the transperitoneal approach and the retroperitoneal approach. Although both techniques are considered safe and effective, existing literature has mainly focused on perioperative outcomes such as operative time, blood loss, warm ischemia time, complications, and oncological results. Limited data are available regarding patient-reported outcomes, including postoperative pain, recovery, and quality of life.\n\nThe RAPTOR study is a prospective clinical study designed to evaluate both patient-reported outcomes after kidney surgery and surgical outcomes associated with different renal artery declamping strategies during robot-assisted partial nephrectomy.\n\nThe first study component (PROMs arm) will compare patients undergoing robot-assisted partial nephrectomy through either a transperitoneal or retroperitoneal approach. The primary objective is to determine whether the retroperitoneal approach results in reduced postoperative pain compared with the transperitoneal approach. Secondary objectives include comparisons of postoperative opioid consumption, recovery after surgery, quality of life, duration of sick leave, perioperative outcomes, oncological outcomes, and long-term renal function.\n\nThe second study component (clamping arm) is a randomized comparison of two commonly used renal artery declamping strategies during robot-assisted partial nephrectomy. During standard declamping, the renal artery clamp remains in place until all renorrhaphy suturing has been completed. During early declamping, the renal artery clamp is removed after closure of the resection bed but before completion of renorrhaphy. Early declamping may reduce warm ischemia time and thereby preserve renal function, but concerns remain regarding the possibility of increased bleeding. Existing evidence suggests that early declamping may reduce ischemia time without clinically relevant increases in blood loss or complications; however, high-level prospective evidence remains limited.\n\nPatients scheduled for surgery for renal cancer at Haukeland University Hospital will be screened for eligibility. Patients undergoing robot-assisted partial nephrectomy will be assigned to either a transperitoneal cohort or a retroperitoneal cohort according to tumor characteristics and surgeon preference. Patients undergoing other forms of kidney cancer surgery, including nephrectomy, will be enrolled as an observational control cohort for analyses involving patient-reported outcomes.\n\nWithin both partial nephrectomy cohorts, patients will undergo stratified block randomization in a 1:1 ratio to either early declamping or standard declamping. Randomization will occur after the surgical approach has been selected to ensure balanced allocation of declamping strategies within both surgical access groups.\n\nPatient-reported outcomes will be assessed using validated Norwegian-language instruments. Pain will be measured using the Brief Pain Inventory (BPI), postoperative recovery using the Quality of Recovery-15 Norwegian version (QoR-15NO), and quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Assessments will be completed preoperatively (baseline), on the first postoperative day, at 6 weeks after surgery, and at 1 year after surgery.\n\nThe primary endpoint in the PROMs arm is change in postoperative pain from baseline to postoperative day one, measured using the mean pain severity score from the Brief Pain Inventory. Secondary endpoints include opioid consumption during the first 24 postoperative hours, pain at 6 weeks and 1 year, postoperative recovery scores, quality-of-life scores, duration of sick leave, operative time, length of hospital stay, postoperative complications, positive surgical margins, transfusions, recurrence-free survival, disease-specific survival, overall survival, and long-term renal function measured by estimated glomerular filtration rate (eGFR).\n\nThe primary endpoint in the clamping arm is intraoperative blood loss during partial nephrectomy. Secondary endpoints include warm ischemia time, postoperative complications, transfusions, operative time, positive surgical margins, renal function, recurrence outcomes, and survival outcomes.\n\nPerioperative variables collected will include operative duration, warm ischemia time, estimated blood loss, postoperative opioid use converted to morphine equivalents, pathology findings, complications graded according to the Clavien-Dindo classification, transfusions, length of stay, renal function, and oncological outcomes. Follow-up assessments will occur at 6 weeks, 1 year, 3 years, and 5 years after surgery. Long-term follow-up will include recurrence-free survival, disease-specific survival, overall survival, and renal function.\n\nThe study is expected to enroll approximately 120-150 patients. Sample size calculations indicate that 88 patients undergoing robot-assisted partial nephrectomy are required to detect a clinically meaningful difference in postoperative pain between surgical approaches and to evaluate non-inferiority of early declamping with respect to blood loss. Enrollment is expected to take approximately 2-3 years.\n\nThe study is conducted in accordance with the Declaration of Helsinki and applicable Norwegian regulations. Written informed consent will be obtained from all participants before enrollment. The patient-reported outcomes component is observational and presents minimal risk beyond completion of questionnaires. In the randomized declamping component, both interventions represent accepted surgical techniques currently used in clinical practice. An interim analysis is planned after approximately half of the randomized participants have been enrolled to assess safety and study conduct.",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"Early declamping","EXPERIMENTAL","Participants undergoing robot-assisted partial nephrectomy randomized to early renal artery declamping. After tumor excision and closure of the resection bed, the renal artery clamp is removed before completion of renorrhaphy. This strategy is intended to reduce warm ischemia time while maintaining acceptable bleeding and complication rates.",[69],"Procedure: Early declamping strategy",{"label":71,"type":72,"description":73,"interventionNames":74},"Standard declamping","ACTIVE_COMPARATOR","Participants undergoing robot-assisted partial nephrectomy randomized to standard renal artery declamping. The renal clamping stays on until all renorraphy and adaptation of the resection surfaces are completed",[75],"Procedure: Standard clamping strategy",[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":55},"PROCEDURE","Standard clamping strategy","Patients randomized to standard declamping will have the clamp on until tumour resection, renorraphy and adaptation of the resection surfaces is performed",[71],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":55},"Early declamping strategy","The patients randomized to early declamping strategy will have the clamp on until tumour resection and ranorraphy is completed, but the clamp is removed before adaptation of the resection surfaces is performed",[65],[87],{"name":88,"affiliation":5,"role":89},"Bjarte Almås, MD.PhD","PRINCIPAL_INVESTIGATOR",[91],{"name":92,"role":93,"phone":94,"phoneExt":55,"email":95},"Bjarte Almås, MD, PhD","CONTACT","+4755971637","bjarte.almas@helse-bergen.no",[97],{"facility":5,"status":55,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Bergen","Vestland","5008","Norway","NO",{"type":104,"coordinates":105},"Point",[106,107],5.32415,60.39299,{"lat":107,"lon":106},[110,111,115,116,119,121,123,125],{"name":92,"role":93,"phone":94,"phoneExt":55,"email":95},{"name":112,"role":93,"phone":113,"phoneExt":55,"email":114},"Karin M. Hjelle, MD, PhD","+4755975000","karin.margrethe.hjelle@helse-bergen.no",{"name":92,"role":89,"phone":55,"phoneExt":55,"email":55},{"name":117,"role":118,"phone":55,"phoneExt":55,"email":55},"Karin M. Hjelle, MD. Associate Professor","SUB_INVESTIGATOR",{"name":120,"role":118,"phone":55,"phoneExt":55,"email":55},"Rachel A. Maheswaran, MD.",{"name":122,"role":118,"phone":55,"phoneExt":55,"email":55},"Christian Beisland, MD.Professor",{"name":124,"role":118,"phone":55,"phoneExt":55,"email":55},"Mathias S. Æsøy, MD, PhD",{"name":126,"role":118,"phone":55,"phoneExt":55,"email":55},"Øyvind Ulvik, MD, Professor",{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"SPONSOR_INVESTIGATOR","Bjarte Almas","MD.PhD Consultant urologist",[132,135],{"name":133,"class":134},"Haukeland University Hospital, Bergen, Norway","UNKNOWN",{"name":136,"class":6},"University of Bergen","100658461","patient-reported-outcomes-and-different-renal-artery-clamping-techniques-during-robot-assisted-kidney-resection-100658461",false,"NCT07853001","Patient Reported Outcomes and Different Renal Artery Clamping Techniques During Robot Assisted Kidney Resection","A Prospective Cohort Study With Emphasis on Patient Reported Outcomes and Different Renal Artery Clamping Techniques During Robot Assisted Kidney Resection - the RAPTOR Study","RAPTOR","Inclusion Criteria:\n\n1. Signed written informed consent obtained prior to any study specific procedures\n2. Patient must be willing and able to comply with the protocol\n3. Age \\>18\n4. Patients scheduled for robot-assisted partial kidney resection with either the trans- or retroperitoneal access\n5. Other patients scheduled for surgery for kidney cancer, to be included as control group\n\n   Exclusion Criteria:\n6. Previous kidney surgery on the affected side\n7. Preexisting extensive intraabdominal adhesions preventing the use of the transabdominal access\n8. Preexisting severe pain condition requiring regular use of opioids adding up to more than equivalent of 10mg po morphine daily\n9. Any other physical or mental illness that according to the treating surgeon makes the patient unfit for inclusion in the study\n10. Confirmed metastatic renal cancer or any other metastatic cancer.","ALL","18 Years",{"count":148,"type":149},130,"ESTIMATED","INTERVENTIONAL",[152],"NA","The target population for this study consists of all patients undergoing kidney surgery at Haukeland University Hospital, Norway, with the primary focus being patients undergoing robot-assisted partial nephrectomy.\n\nThe study has two main objectives. First, the investigators aim to assess whether a flank approach to robot assisted partial nephrectomy may be superior to a trans abdominal approach with regard to postoperative pain, recovery, and quality of life. Second, while conducting this study, the investigators also seek to compare two methods of renal artery clamping during the partial nephrectomy procedure. Specifically, the investigators aim to determine whether a technique that reduces the duration of ischemia can be performed without causing an unacceptable increase in blood loss or postoperative complications.",[155],"Renal Cell Carcinoma (Kidney Cancer)",[157,158,159,160,161,162,163,164,165,166,167,168],"renal cell carcinoma","Robot-Assisted Partial Nephrectomy","Retroperitoneal Approach","Transperitoneal Approach","Patient-Reported Outcomes","Warm Ischemia Time","Postoperative Pain","Postoperative Recovery","Renal Function","Kidney Cancer","Early Declamping","Renal Artery Clamping","NOT_YET_RECRUITING","2026-09-28",{"date":172,"type":173},"2026-10-01","ACTUAL",{"date":175,"type":149},"2026-09",{"date":177,"type":149},"2034-09",{"name":129,"class":6},1]