Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-04 @ 1:05 AM
Study NCT ID:
NCT06604702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat Injection for Rectocele Treatment: A Novel Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020047', 'term': 'Rectocele'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011391', 'term': 'Prolapse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm prospective interventional trial where all participants undergo submucosal fat injections for the treatment of rectocele.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Rectocele Size', 'timeFrame': '6 months post-procedure', 'description': 'The outcome will assess the reduction in rectocele size, measured by clinical examination and defecography. Improvement in rectocele grade will be quantified using a standardized rectocele grading scale.\n\nRectocele Grading Scale:\n\nGrade 0: No prolapse of the rectal wall into the vaginal canal. Grade 1: Mild prolapse, where the rectal wall descends slightly into the vaginal canal, typically during straining, but does not reach the vaginal introitus.\n\nGrade 2: Moderate prolapse, where the rectal wall descends to the level of the vaginal introitus during straining or bowel movements.\n\nGrade 3: Severe prolapse, where the rectal wall protrudes beyond the vaginal introitus, visible externally, especially during straining.\n\nThis scale would be used to assess the reduction in rectocele size over time as part of your primary outcome. You can adjust the wording in the outcome measure description to reflect this specific scale.'}, {'measure': 'Symptom Relief', 'timeFrame': '6 months post-procedure', 'description': "In this we will evaluate the patient's relief from rectocele-associated symptoms, including vaginal bulge and obstructive defecation. This will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire. The PFDI-20 measures the severity of pelvic floor symptoms on a scale of 0 to 4 for each item, with higher scores indicating greater distress.\n\nUnit of Measure: PFDI-20 Symptom Score (0-100, where 0 represents no distress and 100 represents maximum distress)"}], 'secondaryOutcomes': [{'measure': 'Rate of Recurrence of Rectocele', 'timeFrame': '6 months post-procedure', 'description': 'This outcome will track the recurrence of rectocele after the autologous fat injection procedure. Recurrence will be defined as the reappearance of rectocele symptoms or the identification of prolapse on clinical examination or defecography.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Up to 1 week post-procedure', 'description': 'This outcome will assess postoperative pain and discomfort using a standardized pain scale (e.g., Visual Analog Scale) at regular intervals. It will evaluate both the intensity and duration of pain following the fat injection procedure.\n\nVisual Analog Scale (VAS) for Pain:\n\nThe Visual Analog Scale (VAS) is a tool used to measure pain intensity. It consists of a horizontal line, typically 10 cm in length, with the following markers:\n\n0 cm: No Pain 5 cm: Moderate Pain 10 cm: Worst Pain Imaginable Participants will be asked to mark a point on the line that best represents their level of pain. The distance from the \\"No Pain\\" end to the mark is measured in centimeters to give a quantitative assessment of pain intensity.\n\nInterpretation:\n\n0 cm: No Pain 1-3 cm: Mild Pain 4-6 cm: Moderate Pain 7-9 cm: Severe Pain 10 cm: Worst Pain Possible'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectocele', 'Pelvic Floor Dysfunction', 'Fat Grafting', 'Autologous Fat Injection', 'Obstructive Defecation', 'Pelvic Organ Prolapse', 'Vaginal Bulge'], 'conditions': ['Rectocele', 'Pelvic Organ Prolapse', 'Obstructive Defecation Syndrome']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Women aged 18 to 60 years with mild to moderate rectocele, presenting with symptoms such as obstructive defecation or vaginal bulge, will undergo submucosal fat injections. The study will assess the procedure\\'s ability to alleviate symptoms and reduce prolapse recurrence. This prospective, single-arm trial will be conducted at Cairo University Hospitals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female patients ageing from 18 to 60 years presenting to general surgery department of Cairo university hospitals complaining of chronic constipation or obstructed defecation syndrome posterior with posterior vaginal bulge and diagnosed with rectocele', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged between 18 and 60 years.\n* Diagnosis of rectocele confirmed by defecography, with a rectocele size of 2 cm (mild) to 4 cm (moderate).\n* Presenting with symptoms of obstructive defecation syndrome, including constipation, incomplete defecation, and/or vaginal bulge.\n* Able to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have previously undergone surgical repair of rectocele.\n* Presence of thrombosed hemorrhoids.\n* History of sclerotherapy injection for rectocele.\n* Diagnosis of anal stenosis.\n* History of coagulopathy or current use of anticoagulant or antiplatelet medications.\n* Refusal or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06604702', 'briefTitle': 'Fat Injection for Rectocele Treatment: A Novel Approach', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele', 'orgStudyIdInfo': {'id': 'MD-260-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fat Injection for Rectocele', 'description': "Participants in this arm will undergo autologous fat injection as a novel treatment for rectocele. Fat grafts will be harvested from the patient's abdomen, processed to purify the fat, and injected into the submucosal layer of the rectocele through the posterior vaginal wall. This procedure aims to reduce the size of the rectocele, alleviate symptoms like vaginal bulge and obstructive defecation, and prevent recurrence.", 'interventionNames': ['Procedure: Autologous Fat Injection for Rectocele']}], 'interventions': [{'name': 'Autologous Fat Injection for Rectocele', 'type': 'PROCEDURE', 'description': 'In this procedure, autologous fat is harvested from the patient\\'s lower abdomen using a multiport cannula. The fat is then processed via centrifugation to separate the viable fat cells, which are emulsified into nanofat. This nanofat is injected into the submucosal layer of the rectocele through the posterior vaginal wall, using an anoscope for guidance. The procedure is intended to reinforce the rectovaginal fascia, alleviate rectocele symptoms such as obstructive defecation and vaginal bulge, and reduce prolapse recurrence.', 'armGroupLabels': ['Fat Injection for Rectocele']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eslam Mohamed Hagagy Mohamed, MSc', 'role': 'CONTACT', 'email': 'Eslam22hego@gmail.com', 'phone': '01020487095', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available beginning 6 months after publication of the primary results and will be available for 2 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) that underlie the results reported in publications will be shared. This includes data on clinical outcomes, participant demographics, and relevant procedural details. Supporting documents, such as the study protocol and statistical analysis plan, will also be made available.', 'accessCriteria': 'Access to the de-identified dataset will be granted to researchers who provide a methodologically sound proposal, subject to review and approval by the study team. Proposals should be directed to the principal investigator, and approved proposals will require a data use agreement. Data will be shared via secure data-sharing platforms or repositories.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of the General Surgery, Cairo University', 'investigatorFullName': 'Eslam Mohamed Hagagy Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}