Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT01508767
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2012-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062885', 'term': 'Urinary Catheters'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-16', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative urinary retention requiring re-catheterisation', 'timeFrame': '14 days following urethral catheter removal', 'description': 'Development of acute post-operative urinary retention demonstrated by a post-void residual \\>100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.'}], 'secondaryOutcomes': [{'measure': 'Symptomatic bacteruria', 'timeFrame': 'Within 14 days of urethral catheter removal', 'description': 'Should a patient experience lower urinary tract symptoms following catheter removal a mid-stream urine sample will be taken for microscopy and culture. A pure culture of a single organism of \\>100,000 colony forming units will be considered a positive culture.'}, {'measure': 'Pulmonary complications', 'timeFrame': 'For the first 14 days post-operatively', 'description': 'The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.'}, {'measure': 'Surgical site infection', 'timeFrame': 'Within 7 days post-operatively', 'description': 'The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Retention']}, 'referencesModule': {'references': [{'pmid': '34184246', 'type': 'DERIVED', 'citation': 'Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.'}, {'pmid': '25769395', 'type': 'DERIVED', 'citation': 'Coyle D, Joyce KM, Garvin JT, Regan M, McAnena OJ, Neary PM, Joyce MR. Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia - a prospective pilot clinical study. Int J Surg. 2015 Apr;16(Pt A):94-98. doi: 10.1016/j.ijsu.2015.03.003. Epub 2015 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.\n\nTraditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.', 'detailedDescription': 'Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Competent to consent to participate in trial\n* Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).\n* Receiving epidural analgesia post-operatively\n* If male, international prostate symptom score \\<20.\n\nExclusion Criteria:\n\n* Previous lower urinary tract surgery\n* Chronic lower urinary tract disease\n* Intermittent self-catheterisation\n* Neurogenic bladder\n* Urethral catheter inserted \\>24 hours pre-operatively\n* Presence of pelvic sepsis/abscess at surgery\n* Previous trans-abdominal pelvic surgery\n* Urethral catheter required for urine output monitoring beyond 24 hours post-operatively\n* Presence of enterovesical fistula\n* Pre-operative use of medications which alter detrusor function\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01508767', 'briefTitle': 'Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University College Hospital Galway'}, 'officialTitle': 'Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia', 'orgStudyIdInfo': {'id': 'Joyce-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group 1', 'description': 'Early removal of urethral catheter 48 hours post-operatively.', 'interventionNames': ['Other: Removal of urethral catheter']}, {'type': 'OTHER', 'label': 'Study group 2', 'description': 'Removal of urethral catheter once epidural analgesia has been withdrawn.', 'interventionNames': ['Other: Removal of urethral catheter']}], 'interventions': [{'name': 'Removal of urethral catheter', 'type': 'OTHER', 'otherNames': ['Urethral catheter', 'Indwelling Urinary catheter', 'Indwelling urethral catheter'], 'description': 'All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior to undergoing colorectal resection. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 48 hours following surgery. Participants assigned to the control group will have their urethral catheters removed within 12 hours of withdrawal of the epidural infusion, as is standard practice in our institution.', 'armGroupLabels': ['Study group 1', 'Study group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'state': 'Co. Galway', 'country': 'Ireland', 'facility': 'University College Hospital Galway', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Myles R. Joyce, MB, BCh, BAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Hospital Galway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Hospital Galway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant colorectal and general surgeon', 'investigatorFullName': 'Myles Joyce', 'investigatorAffiliation': 'University College Hospital Galway'}}}}