Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-25 @ 3:03 PM
Study NCT ID:
NCT03848468
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2019-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061865', 'term': 'Hemorrhoidectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Covidien 5mm ligasure'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes', 'description': 'was measured from start of incision to the dressing in minutes'}, {'measure': 'mean postoperative pain', 'timeFrame': 'each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours', 'description': 'on Visual analogue scale,a scale to assess the post operative pain ,8-10 as maximum pain, 5-7 as moderate pain, 2-4 minimum pain, 1-0 as no pain and change in final outcome has been assessed after 48 hours'}, {'measure': 'wound healing', 'timeFrame': 'to assess change in the parameter in 3 weeks', 'description': 'assessed in scheduled appointment every week and has been defined as complete epithelization on physical examination .Wound was graded as 1-sloughy, 2-no granulation, 3-granulation, 4-epithelizing , 5-completely epithelized'}, {'measure': 'Return to work', 'timeFrame': 'assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days', 'description': 'has been defined as day of discharge till resume of work that is patient is able to perform daily routine activities normally as before operation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Visual Analogue pain score', 'conventional Hemorrhoidectomy', 'Ligasure Hemorrhoidectomy'], 'conditions': ['Hemorrhoidectomy', 'Hemorrhoids Third Degree', 'Hemorrhoids Fourth Degree', 'Operative Time', 'Pain, Postoperative', 'Wound Healing', 'Return to Work']}, 'descriptionModule': {'briefSummary': 'A comparison study was performed between Ligasure and Milligan morgan hemorrhoidectomy to find out the outcome between these two techniques in 3rd and 4th degree hemorrhoids.This advance vessel sealing device is used to seal the pedicle of the vessel and does not burn the surrounding tissues , so the outcome was monitored in terms of operative time, post operative pain pain, duration of wound healing in 3 weeks and return to normal activities', 'detailedDescription': 'INTRODUCTION:\n\nMilligan Morgan hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in ligasure hemorrhoidectomy have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time, wound healing and return to normal activities.\n\nOBJECTIVES:\n\nTo compare the outcome of ligasure hemorrhoidectomy with conventional hemorrhoidectomy in III and IV degree hemorrhoids.\n\nSTUDY DESIGN:\n\nRandomized controlled trial\n\nSTUDY SETTING:\n\nThe study was conducted in surgical unit 1, Services hospital, Lahore.\n\nDURATION OF STUDY:\n\nStudy was completed in six months after the approval of synopsis i.e. from 1st April 2014 to 30th September 2014.\n\nDATA COLLECTION PROCEDURE:\n\nAfter approval from hospital ethical committee, 100 patients fulfilling the inclusion criteria has been recruited from outdoor and emergency department. A detailed history had been taken including demographic data (age, address) and all patients had been clinically examined .Patients was divided in two groups randomly using random number tables. Group A: Conventional hemorrhoidectomy. Group B: Ligasure hemorrhoidectomy. Patients had been requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures have been performed by a single surgical operating team to control bias. Preoperatively operative time was noted. Post operatively pain had been assessed after 6 hours, 24 hours, and 48 hours, wound has been assessed in 2nd and 3rd postoperative week to assess epithelization and return to normal activities in days. All data had been collected and recorded on the Proforma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with III and IV degree hemorrhoids assessed on proctoscopy had been included in this study.\n\nExclusion Criteria:\n\n* Patients with permanently prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy\n* Any other anorectal pathology on history and per rectal examination\n* Previous anal surgery assessed by history and per rectal examination\n* Inability to give informed consent\n* ASA(American Society of Anesthesiologists) grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic and renal profile and evidence of ischemic heart disease'}, 'identificationModule': {'nctId': 'NCT03848468', 'briefTitle': 'Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Hospital, Lahore'}, 'officialTitle': 'Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.', 'orgStudyIdInfo': {'id': 'ServicesH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CH(conventional Hemorrhoidectomy)', 'description': 'conventional hemorrhoidectomy', 'interventionNames': ['Procedure: Hemorrhoidectomy']}, {'type': 'EXPERIMENTAL', 'label': 'LH (Ligasure Hemorrhoidectomy)', 'description': 'Ligasure hemorrhoidectomy', 'interventionNames': ['Procedure: Hemorrhoidectomy']}], 'interventions': [{'name': 'Hemorrhoidectomy', 'type': 'PROCEDURE', 'description': 'excision of 3rd and 4th degree hemorrhoids', 'armGroupLabels': ['CH(conventional Hemorrhoidectomy)', 'LH (Ligasure Hemorrhoidectomy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'services Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Hospital, Lahore', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Safia Zahir Ahmed', 'investigatorAffiliation': 'Services Hospital, Lahore'}}}}