Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-03-05 @ 1:15 PM
Study NCT ID:
NCT02295592
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2014-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 780}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the recurrence rate of the severe prolapsed Hemorrhoids after surgery', 'timeFrame': '2 years', 'description': '780 patients will be enrolled in one year.All patients will be followed up for one year, and then calculate 1 year recurrence rate between TSTstarr+ group and PPH group'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': '1 year'}, {'measure': 'Intraoperative hemorrhage', 'timeFrame': '1 year'}, {'measure': 'The weight of specimens', 'timeFrame': '1year'}, {'measure': 'The volume of specimens', 'timeFrame': '1year'}, {'measure': 'The number of patients with anal pain after surgery', 'timeFrame': '2 years'}, {'measure': 'The number of patients with fecal urgency after surgery', 'timeFrame': '2 years'}, {'measure': 'The number of patients with stricture of anus after surgery', 'timeFrame': '2 years'}, {'measure': 'The number of patients with hemorrhage after surgery', 'timeFrame': '2 years'}, {'measure': 'The number of patients with retention of urine in the early time after surgery', 'timeFrame': '2 years'}, {'measure': 'The number of patients with edema of the anal margin in the early time after surgery', 'timeFrame': '2 years'}, {'measure': 'The time of returning to normal', 'timeFrame': '2 years'}, {'measure': 'The total cost of hospitalization', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemorrhoids', 'The recurrence rate', 'PPH', 'TSTstarr+'], 'conditions': ['Hemorrhoids']}, 'descriptionModule': {'briefSummary': 'TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe prolapsed hemorrhoids\n* no significant anal-malformation before operation\n* having signed the informed consent.\n\nExclusion Criteria:\n\n* needing emergency operation or having previous history of hemorrhoids operation\n* with other anal diseases at the same time such as : anal fissure, anal fistula and perianal abscess and so on\n* diagnosed with inflammatory bowel disease or proctitis\n* diagnosed with colorectal cancer\n* associated with cardiovascular and cerebrovascular diseases and other diseases so that can not tolerate surgery or increase the risk of surgery\n* with chronic or acute renal insufficiency patients\n* coagulation abnormalities or with anticoagulation treatment at present\n* diagnosed with diabetes with poor glycemic control\n* in women with pregnant or menstruation\n* The intellectual disabilities or mental disorder\n* had participated in other clinical trial before we selected 4 weeks\n* other severe complications.'}, 'identificationModule': {'nctId': 'NCT02295592', 'briefTitle': 'TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'orgStudyIdInfo': {'id': '2014ZSLYEC-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A( TSTstarr+ group)', 'description': 'TSTstarr+ is a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation .', 'interventionNames': ['Procedure: TSTstarr+']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B ( PPH group)', 'description': 'PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.', 'interventionNames': ['Procedure: PPH']}], 'interventions': [{'name': 'TSTstarr+', 'type': 'PROCEDURE', 'description': 'TSTstarr+ : a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler, " +" means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation .', 'armGroupLabels': ['group A( TSTstarr+ group)']}, {'name': 'PPH', 'type': 'PROCEDURE', 'description': 'PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.', 'armGroupLabels': ['group B ( PPH group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lin Hongcheng, Medicine Doctor', 'role': 'CONTACT', 'email': 'linhongcheng@hotmail.com', 'phone': '+86 159158157 76'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Suzhou Touchstone International Medical Science Co.,Ltd.', 'class': 'UNKNOWN'}, {'name': 'Chengdu Anorectal Hospital', 'class': 'UNKNOWN'}, {'name': 'Wuhan University', 'class': 'OTHER'}, {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Nanhai Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Changshu Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Xuzhou Central Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'Shenyang Anorectal Hospital', 'class': 'OTHER'}, {'name': 'Wulumuqi General Hospital of Lanzhou Military Command', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Guangxi traditional Chinese Medicine University', 'class': 'UNKNOWN'}, {'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}