Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-04-23 @ 3:07 AM
Study NCT ID:
NCT05596357
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2022-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incisional heRnia dIgestion Sexuality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analysis of sexual function -->Femal Sexual Function Index (FSFI) and Male Sexual Health Questionnaire (MHSQ).', 'timeFrame': '25 months', 'description': 'Analyze changes in sexual function before (1 month) and after surgical operation (M3 M12, M24)'}, {'measure': 'Changes in quality of life analysis --> Medical Outcome Study Short Form 12 (SF12),', 'timeFrame': '25 months', 'description': 'Analyze changes in quality of life before (1 month) and after surgical operation (M3 M12, M24)'}, {'measure': 'Clinical recurrence', 'timeFrame': '36 months', 'description': 'Assessment of clinical recurrence M1, M3, M6, M12, M24, M36 after surgical operation'}, {'measure': 'Radiological recurrence', 'timeFrame': '24 months', 'description': 'Assessment of radiological recurrence at M24 after surgical operation'}, {'measure': 'Death', 'timeFrame': '36 months', 'description': 'Assessment of the mortality up to M36 after surgical operation'}, {'measure': 'Pain analysis--> Visual Analog Scale (VAS)', 'timeFrame': '36 months', 'description': 'Analyze postoperative pain: M1, M3, M6, M12, M24 and M36'}, {'measure': 'Morbidity --> Sepsis on mesh, hematoma, seroma, reoperation for complication, removal of the parietal mesh.', 'timeFrame': '1 month', 'description': 'Assessment of morbidity after surgical operation'}], 'primaryOutcomes': [{'measure': 'Symtoms of constipation --> Patient Assessment of Constipation Symptoms (PAC-SYM)', 'timeFrame': '25 months', 'description': 'Analyze changes in symptoms related to constipation before (1 month) and after surgical operation (M3, M12 and M24)'}], 'secondaryOutcomes': [{'measure': 'Quality of life related to constipation -->Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)', 'timeFrame': '25 months', 'description': 'Assessment of qualitiy of life related to constipation before (1 month) and after surgical operation (M3, M12 and M 24)'}, {'measure': 'Quality of life related to digestive function--> Gastrointestinal Quality of Life index (GIQLI)', 'timeFrame': '25 months', 'description': 'Assessment of qualitiy of life related to digestive function before (1 month) and after surgical operation (M3, M12 and M 24)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients', 'detailedDescription': "Almost 20% of patients operated on the abdomen will present with an incisional hernia and each year in France, more than 50,000 patients are operated on for an eventration with placement of a parietal mesh.\n\nThese incisional hernia, corresponding to the permanent exteriorization of the abdominal viscera contained in a peritoneal sac through a scar muscle defect in the abdominal wall, are responsible for major anatomical and physiological alterations affecting the respiratory, cardiovascular and musculoskeletal systems.\n\nSometimes the hernia sac is so large that the viscera have lost their place in the abdomen . The presence of a large protrusion of the anterior abdomen alters the patient's center of gravity, affecting his ambulation and posture\n\nThus, surgical repair of the abdomen, indicated to correct chronic pain, functional limitation and cosmetic damage related to incisional hernia, helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of the patients. The consequent benefits on the quality of life and the reduction of chronic pain have been demonstrated by several studies, including a randomized trial \\[Rogmark, but certain aspects of the functional limitations linked to the presence of an eventration have never been studied (not published), as well as their specific impact on quality of life.\n\nIn fact, the daily experience of the management of these pathologies suggests that most patients with an abdominal wall problem, on the one hand, evoke difficulties to exonerate (abdominal pushing efforts are rendered ineffective due to the leakage of abdominal pressure in the incisional hernia sac, sometimes forcing patients to contain their stomachs by manual maneuvers or to wear an abdominal belt) and on the other hand difficulty having sexual intercourse (gene linked to the protrusion of abdomen, impaired body image and self-esteem).\n\nThus, a better knowledge of the actual digestive and sexual functional damage linked to these parietal pathologies, will make it possible to optimize the care of patients who will be better informed about their disease and the benefits they can expect from parietal repair (ease of having a bowel movement, improvement of sex life, benefits on quality of life)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients operated on on the abdomen will present with an eventration (incisional hernia)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 79\n* No opposition to research\n* Planned surgery to cure a hernia or complex anterior eventration of the abdomen by laparotomy or laparoscopy\n* Mastery of the French language sufficient to answer questionnaires\n\n * Registration in a national health care system\n\nExclusion Criteria:\n\n* Emergency surgery\n* ASA (American Society of Anesthesiologists) score\\> 3 during the preoperative consultation\n* Current pregnancy or breastfeeding\n* Patient under guardianship or curatorship\n* Patient under AME (State Medical Aid)'}, 'identificationModule': {'nctId': 'NCT05596357', 'acronym': 'IRIS', 'briefTitle': 'Incisional heRnia dIgestion Sexuality', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Observational Study of the Benefits of Complex Abdominal Wall Repairs on Quality of Life , Digestive and Sexual Functions.', 'orgStudyIdInfo': {'id': '2021-A01003-38'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': 'The patient must answer questionnaires before and after reconstructive surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'David Moszkowicz', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'centralContacts': [{'name': 'David MOSZKOWICZ, Pr', 'role': 'CONTACT', 'email': 'david.moszkowicz@aphp.fr', 'phone': '0033147606384'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}