Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-01 @ 7:26 PM
Study NCT ID:
NCT06881303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D011125', 'term': 'Adenomatous Polyposis Coli'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnary : quality of life', 'timeFrame': 'From enrollment to the end of the study at 24 months'}], 'secondaryOutcomes': [{'measure': 'occurrence of short-term stomatal complications (within 30 days days post-operatively)', 'timeFrame': 'From intervention to 30 days after intervention', 'description': 'edema, necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions'}, {'measure': "Questionnaire about the patient's autonomy when returning home (stoma therapist needed or not; if present, for how long)", 'timeFrame': 'From intervention to 30 days after intervention', 'description': 'stoma therapist needed or not; if present, for how long'}, {'measure': 'rate of long-term stomatal complications at 1 year', 'timeFrame': 'From intervention to1 year after intervention', 'description': 'prolapse, occlusion, ventration'}, {'measure': 'questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 30 days, for comparison between identification and education by the stoma nurse or surgeon', 'timeFrame': 'From intervention to 30 days after intervention'}, {'measure': 'Questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 1 years', 'timeFrame': 'From intervention to 1 year after intervention'}, {'measure': 'SF36 quality of life questionnaire at 30 days and 1 year', 'timeFrame': 'From intervention to 1 year after intervention'}, {'measure': 'Rate of restoration of digestive continuity at 1 year', 'timeFrame': 'From intervention to 1 year after intervention'}, {'measure': 'Reasons for not carrying out preoperative identification and education', 'timeFrame': 'From enrollment to the end of the study at 24 months', 'description': "emergency, surgery at night or on weekends or public holidays, insufficient preoperative time, stoma nurse absent, surgeon's choice, patient's wishes."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Anastomosis', 'Endometrial', 'Anastomotic Leak Rectum', 'Ulcerative Colitis (Disorder)', 'Adenomatous Polyposis Coli, Familial', 'Crohn Disease', 'Digestive Cancers', 'Protectomy']}, 'descriptionModule': {'briefSummary': 'There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What\'s more, a temporary stoma can become permanent.\n\nThe positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What\'s more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.\n\nThe impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.\n\nHowever, despite this "Evidence Based Medicine", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.\n\nTo this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.\n\nThe main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:\n\n* unexposed group: no preoperative stoma identification and education\n* exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.\n\nTotal 100 patients :\n\n* In scheduled surgery: 30 exposed and 30 unexposed patients\n* In emergency surgery: 10 exposed and 30 unexposed patients\n\nTimeline:\n\nInclusion period: 12 months Follow-up period: 12 months Total duration: 24 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 18 and over\n* for whom a fecal diversion stoma is planned on a scheduled or emergency basis\n* affiliated with the French social security system\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),\n* No digestive stoma or fecal diversion planned\n* Person who does not understand French'}, 'identificationModule': {'nctId': 'NCT06881303', 'acronym': 'RESTODIG', 'briefTitle': 'Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion', 'orgStudyIdInfo': {'id': 'RCAPHM23_0029'}, 'secondaryIdInfos': [{'id': '2023-A01631-44', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative identification and education', 'interventionNames': ['Other: preoperative stoma identification and education']}, {'type': 'NO_INTERVENTION', 'label': 'lack of preoperative identification and education'}], 'interventions': [{'name': 'preoperative stoma identification and education', 'type': 'OTHER', 'description': "The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively, in the lying, sitting and standing positions, so that the patient can see the stoma. What's more, the psychological impact of the stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.", 'armGroupLabels': ['Preoperative identification and education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Maéva Donadieu-Masse', 'role': 'CONTACT', 'email': 'promotion.interne@ap-hm.fr', 'phone': '0491435817', 'phoneExt': '33'}], 'facility': 'Assistance publique - Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Maéva Donadieu-Masse', 'role': 'CONTACT', 'email': 'promotion.interne@ap-hm.fr', 'phone': '0491435817', 'phoneExt': '33'}, {'name': 'Diane MEGE, dr', 'role': 'CONTACT', 'email': 'promotion.interne@ap-hm.fr', 'phone': '0491435817', 'phoneExt': '33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}