Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 2:09 PM
Study NCT ID:
NCT01953250
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2013-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-09-25', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ColoRectal Functional Outcome', 'timeFrame': '1 day', 'description': 'Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Deep infiltrating endometriosis', 'Laparoscopic sigmoid resection', 'laparoscopic rectum resection', 'Colorectal surgery'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.', 'detailedDescription': 'A questionnaire will be sent to every patient by mail. The questionnaire that will be used is the COREFO questionnaire (ColoRectal Functional Outcome).\n\nDepending on the amount of responses, we will try to make connections between peri-operative data and functional outcome after considerable period of follow-up. Peri-operative factors include grade of endometriosis, surgical technique and post-operative complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01953250', 'briefTitle': 'Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'To Assess the Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection', 'orgStudyIdInfo': {'id': 'S-54351'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infiltrating endometriosis', 'description': '272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis, in the department of Abdominal Surgery, University Hospital Leuven, between the year 1997 and September 2011.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Flemish Brabant', 'country': 'Belgium', 'facility': 'University Clinics Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': "André JL D'Hoore, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinics Gasthuisberg Department of Abdominal Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}