Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-29 @ 10:02 PM
Study NCT ID:
NCT04672603
Status:
UNKNOWN
Last Update Posted:
2021-04-29
First Post:
2020-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of sexual dysfunction', 'timeFrame': '1 month', 'description': 'IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function'}, {'measure': 'Incidence of urinary dysfunction', 'timeFrame': '1 month', 'description': 'IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function'}], 'secondaryOutcomes': [{'measure': 'Incidence of sexual dysfunction', 'timeFrame': '9 months', 'description': 'IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function'}, {'measure': 'Incidence of urinary dysfunction', 'timeFrame': '9 months', 'description': 'IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function'}, {'measure': 'Quality of life assessed with GIQLI questionnaires', 'timeFrame': '1month', 'description': 'GIQLI questionnaires are used to assess quality of life'}, {'measure': 'Quality of life assessed with GIQLI questionnaires', 'timeFrame': '9 months', 'description': 'GIQLI questionnaires are used to assess quality of life'}, {'measure': '1-year local recurrence', 'timeFrame': '1 year', 'description': '1-year local recurrence'}, {'measure': '1-year overall survival rate', 'timeFrame': '1 year', 'description': '1-year overall survival rate'}, {'measure': 'Positive Circumferential Resection Margin Rate', 'timeFrame': '1 week', 'description': 'Positive Circumferential Resection Margin Rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urogenital Function', "Denonvilliers' Fascia"], 'conditions': ['Rectal Cancer', 'Advanced Cancer']}, 'descriptionModule': {'briefSummary': "Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathological diagnosis of rectal adenocarcinoma;\n2. Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);\n3. Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;\n4. R0 surgical results is expected by transabdominal or transanal TME/TSME;\n5. 18 \\< age (years) \\< 71, informed consent;\n6. Normal erection function (IIEF-5\\>21), ejaculation function grading as I level, FSFI \\> 26, normal urinary function (Bladder residual urine\\<100ml);\n7. Preoperative ASA grade I \\~ III, no serious systemic disease;\n\nExclusion Criteria:\n\n1. Preoperatively confirmed peritoneum or distant metastasis;\n2. Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;\n3. With other malignant diseases;\n4. With acute ileus, perforation or hemorrhage,need emergency surgery;\n5. Critical organs dysfunction, unable to tolerate laparoscopic surgery;\n6. With severe mental illness, cannot be evaluated;'}, 'identificationModule': {'nctId': 'NCT04672603', 'briefTitle': "Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer", 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': "Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study", 'orgStudyIdInfo': {'id': 'UGFS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complete Preservation of Denonvilliers Fascia', 'description': 'Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.', 'interventionNames': ["Procedure: Complete Preservation of Denonvilliers' Fascia"]}, {'type': 'NO_INTERVENTION', 'label': 'Partial Preservation of Denonvilliers Fascia', 'description': 'Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.'}], 'interventions': [{'name': "Complete Preservation of Denonvilliers' Fascia", 'type': 'PROCEDURE', 'description': 'Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia', 'armGroupLabels': ['Complete Preservation of Denonvilliers Fascia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bing Zeng, M.D.', 'role': 'CONTACT', 'email': 'zengbing3@mail.sysu.edu.cn', 'phone': '8613450366467'}], 'facility': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Bing Zeng, M.D.', 'role': 'CONTACT', 'email': 'zengbing3@mail.sysu.edu.cn', 'phone': '8613450366467'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}