Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-01 @ 1:00 PM
Study NCT ID:
NCT04694950
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2020-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Recovery 15 (QoR-15) score', 'timeFrame': 'Preoperative, postoperative up to day 7', 'description': 'Quality of Recovery 15. A total of 15 questions each answered with a value from 0 to 10. The minimum value of the QoR-15 is 0 and the maximum value is 150. A higher value means a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Up to postoperative day 3', 'description': 'Measurement of pain in rest and in movement with the Numeric Rating Scale (NRS) Pain Scale. Minimum value is 0 (no pain) and maximum value is 10 (extreme pain).'}, {'measure': 'PONV', 'timeFrame': 'Up to postoperative day 3', 'description': 'Measurement of the frequency of postoperative nausea and vomiting (PONV).'}, {'measure': 'Return of bowel function', 'timeFrame': 'Up to postoperative day 7', 'description': 'Time to first passing of flatus and first passing of stool.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Up to postoperative day 30', 'description': 'Using the Clavien-Dindo Classification'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Recovery', 'Urology', 'Pain', 'PONV', 'Postoperative Complications', 'Laparoscopic']}, 'descriptionModule': {'briefSummary': 'Previously published studies show that adding intrathecal morphine to general anesthesia can reduce the postoperative pain and length of stay (LOS) in varies types of surgery. A recent meta-analysis showed that the addition of intrathecal morphine at doses below 500µg did not increase the risk of respiratory depression compared with a control group receiving intravenous opioids. Epidural analgesia is uncommonly used for robot-assisted laparoscopic procedures due to the limited surgical trauma. In addition, the risks associated with the epidural itself such as infection and spinal hematoma are thought to outweigh its possible benefits for these procedures.\n\nAt Linkoping University Hospital a combination of general anesthesia and intrathecal morphine in robot-assisted laparoscopic radical prostatectomy and in robotic-assisted laparoscopic cystectomy is now routinely used in order to improve postoperative recovery. However whether this approach is beneficial in other types of robotic-assisted urological procedures is unknown.\n\nTherefore the investigators aim to conduct a feasibility study for the use of intrathecal morphine combined with general anaesthesia in adult patients undergoing elective urologic laparoscopic robot-assisted surgery at Linkoping University Hospital. The investigators will include 30 patients in the study. The specific aims are to investigate the feasibility and sensitivity of Quality of Recovery 15 (QoR15), as an outcome tool measuring postoperative well-being in this patient cohort.\n\nThe investigators will also investigate the feasibility of other outcome measures such as postoperative pain, post-anesthesia care unit LOS, occurrence of pruritus and hospital LOS.\n\nFor planning of the timeframe of the future interventional study the investigators will use this feasibility study to examine the inclusion rate of study patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population undergoing elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital, sweden.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital\n\nExclusion Criteria:\n\n* Age \\<18\n* Not expected to comprehend the written or verbal study information\n* Patient planned for robotic assisted laparoscoic prostatectomy or robotic assisted laparoscopic cystectomy\n* Acute surgery\n* ASA class \\>3\n* Major surgery on another organ planned at the same operation\n* Patient planned for a neuraxial blockade in addition to general anaesthesia.\n* Study personal not available'}, 'identificationModule': {'nctId': 'NCT04694950', 'briefTitle': 'Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study', 'orgStudyIdInfo': {'id': '210101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group feasibility', 'description': 'Adults undergoing elective urologic laparoscopic robotic surgery.', 'interventionNames': ['Procedure: Usual care']}], 'interventions': [{'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'Intravenous morphine according to clinician´s discretion.', 'armGroupLabels': ['Group feasibility']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linkoping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Michelle Chew, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Martin Holmberg', 'investigatorAffiliation': 'Linkoeping University'}}}}