Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
Study NCT ID:
NCT06803550
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D006484', 'term': 'Hemorrhoids'}, {'id': 'D005401', 'term': 'Fissure in Ano'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '72-hours postoperative urinary retention after anorectal surgery', 'timeFrame': '72 hours after surgery', 'description': 'the inability to void, with the patient needing bladder decompression by catheterization as determined by the treating clinician within 1 week of surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS', 'Postoperative urinary retention', 'Benign anorectal conditions', 'Anal fistula', 'Anal fissure', 'Haemorrhoids'], 'conditions': ['Anal Fistula', 'Anal Fissure Chronic', 'Haemorrhoid', 'Enhanced Recovery After Surgery (ERAS) Protocol']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.', 'detailedDescription': "This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.\n\nPatients of both sexes aged between 18 and 90 years old presented; with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study.\n\nEligible patients will be randomized in equal proportions to RRAS or ROUTINE pathways. The ERAS pathway was developed based on the available guidelines and protocols it includes 14 items.\n\nPatients allocated to ERAS pathway must fulfill all the 14 items. The ROUTINE pathway will represent the routine practice which may include certain ERAS items or those who will not fulfill the 14 items.\n\nFor the end points of the study, all patients will be followed-up by a phone call 72 hours postoperatively then in the outpatients' department for a period of a total of 30 days postoperatively. However, patients will be advised to visit the outpatients' department at any other time during the trial if they developed any unfavorable event.\n\nThe primary outcome will be the 72-hours postoperative urinary retention after anorectal surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both sexes\n* aged between 18 and 65 years old\n* presented with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study\n\nExclusion Criteria:\n\n* younger than 18\n* older than 65 years old\n* pregnant female\n* history of relevant urological diagnosis (benign prostatic hyperplasia/prostate cancer/urethral stricture/bladder neck stenosis/detrusor underactivity/detrusor overactivity)\n* history of relevant urological procedure (radical prostatectomy/ transurethral prostatectomy/bladder neck or urethral surgery/pelvic radiotherapy)\n* use of permanent urinary catheter\n* intraoperative urological procedures\n* with any form of urinary diversion\n* severe cognitive impairment\n* who undergo other anorectal procedures'}, 'identificationModule': {'nctId': 'NCT06803550', 'briefTitle': 'Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effect of Enhanced Recovery After Surgery in Reducing the Incidence of Postoperative Urinary Retention After Surgery for Benign Anorectal Conditions: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'R.24.11.2877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced recovery after surgery protocol', 'description': 'ERAS pathway was developed based on the available guidelines and protocols it includes 14 items', 'interventionNames': ['Other: Enhanced recovery after surgery protocol']}, {'type': 'OTHER', 'label': 'Routine practice', 'description': 'This is the routine preoperative preparation', 'interventionNames': ['Other: Routine pathway']}], 'interventions': [{'name': 'Enhanced recovery after surgery protocol', 'type': 'OTHER', 'description': 'ERAS pathway was developed based on the available guidelines and protocols it includes 14 items:\n\n1. Preoperative patient education using an information sheet which includes instructions on postoperative wound care, pain management, and preventing and managing constipation.\n2. Single preoperative enema 2 hours prior to surgery.\n3. Solid or semisolid food stopped 6 hours before surgery.\n4. Clear liquids may be continued up to 2 hours before surgery.\n5. Preoperative carbohydrate loading in non-diabetic patients for up to 2 hours prior to surgery in the form of a single 330 ml high-carbohydrate clear drink (apple juice).\n6. Saddle anesthesia.\n7. Single dose of intravenous 500 mg metronidazole at the time of the anaesthesi induction.\n8. Restriction of intraoperative intravenous fluids to less than 500 ml.\n9. Balanced chloride-restricted crystalloid solutions should be used for maintenance infusions and fluid boluses.\n10. A bundle measures to reduce surgical site infection which includes', 'armGroupLabels': ['Enhanced recovery after surgery protocol']}, {'name': 'Routine pathway', 'type': 'OTHER', 'description': 'This is the routine preoperative preparation at our institute', 'armGroupLabels': ['Routine practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa Shalaby, MBBCh, MSc, MD, PhD, FACS', 'role': 'CONTACT', 'email': 'mostafashalaby@mans.edu.eg', 'phone': '00201020555605'}], 'facility': 'Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mostafa Shalaby, MD, PhD', 'role': 'CONTACT', 'email': 'mostafashalaby@mans.edu.eg', 'phone': '00201020555605'}], 'overallOfficials': [{'name': 'Mostafa Shalaby, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor & Consultant Colorectal Surgery', 'investigatorFullName': 'Mostafa shalaby, MD, MSc, PhD', 'investigatorAffiliation': 'Mansoura University'}}}}