Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-28 @ 2:05 AM
Study NCT ID:
NCT00939861
Status:
UNKNOWN
Last Update Posted:
2009-07-15
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopy Versus Laparotomy for Colorectal Endometriosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-14', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-14', 'lastUpdatePostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of dyschesia at 6 months using a visual analogue scale', 'timeFrame': 'at 6 months'}], 'secondaryOutcomes': [{'measure': 'Evaluation of gynaecologic symptoms (dysmenorrhea, dyspareunia), digestive symptoms (diarrhea, constipation , intestinal cramps) and general symptoms (asthenia, back pain) at 6 months using visual analogue scale', 'timeFrame': 'at 6 months'}, {'measure': 'Evaluation of quality of life at 6 months using SF-36 questionnaire', 'timeFrame': 'at 6 months'}, {'measure': 'Morbidity', 'timeFrame': 'During 6 months'}, {'measure': 'Postoperative fertility', 'timeFrame': 'during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal endometriosis, laparoscopy, laparotomy', 'gynecologic and digestive symptoms', 'quality of life (SF-36 questionnaire)', 'morbidity', 'fertility'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '25294552', 'type': 'DERIVED', 'citation': 'Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Darai E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia.', 'detailedDescription': 'For all patients, colorectal endometriosis will be confirmed preoperatively by clinical examination, transvaginal sonography, rectal endoscopic sonography and magnetic resonance imaging.Among patients with an indication of surgery, the intensity of dyschesia and other gynecological or digestive disorders will be evaluated pre-operatively using a visual analogue scale. Quality of life will be assessed using the SF-36 questionnaire. The allocation of the surgical route will be conducted by lottery the day before surgery. Patients will be reviewed postoperatively at 1 month and a new assessment of symptoms will be made at 6 months. The duration of the study will be 7 months for the patient and 24 months in total.If considering the two surgical routes as equivalent, with a delta score (after-before surgery) = ±2, standard deviation = 1.55, risk α=2.5%, risk β=10%, and taking into account that prevalence of dyschesia in the study population is 63%, 52 patients will be included.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years old\n* patients with colorectal endometriosis\n* patients affiliated to the French Health Care system\n* patients having signed the inform consent.\n* patients who can speak and read French\n\nExclusion Criteria:\n\n* patients with prior colorectal surgery\n* patients with a contraindication to laparoscopy'}, 'identificationModule': {'nctId': 'NCT00939861', 'briefTitle': 'Laparoscopy Versus Laparotomy for Colorectal Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Tenon Hospital, Paris'}, 'officialTitle': 'Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis', 'orgStudyIdInfo': {'id': '13072009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'laparoscopy', 'interventionNames': ['Procedure: laparoscopy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'laparotomy', 'interventionNames': ['Procedure: laparotomy']}], 'interventions': [{'name': 'laparoscopy', 'type': 'PROCEDURE', 'description': 'colorectal resection', 'armGroupLabels': ['1']}, {'name': 'laparotomy', 'type': 'PROCEDURE', 'description': 'colorectal resection', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Tenon Hospital, Departement of Obstetrics and Gynecology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'emile Daraï, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tenon Hospital, Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Emile Daraï', 'oldOrganization': 'Departement of Obstetrics and Gynecology, Tenon Hospital'}}}}