Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02435758
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2015-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2015-04-26', 'studyFirstSubmitQcDate': '2015-05-02', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary function', 'timeFrame': '14 days', 'description': 'Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function'}, {'measure': 'Sexual function', 'timeFrame': '14 days', 'description': 'IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '30 days', 'description': 'incidence of postoperatvie complications'}, {'measure': '3-year overall survival rate', 'timeFrame': '36 months', 'description': '3-year overall survival rate'}, {'measure': '3-year recurrence pattern', 'timeFrame': '36 months', 'description': '3-year recurrence pattern'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'incidence of postoperatvie deaths'}, {'measure': '5-year overall survival rate', 'timeFrame': '60 months', 'description': '5-year overall survival rate'}, {'measure': '5-year recurrence pattern', 'timeFrame': '60 months', 'description': '5-year recurrence pattern'}, {'measure': '3-year disease free survival rate', 'timeFrame': '36 months', 'description': '3-year disease free survival rate'}, {'measure': '5-year disease free survival rate', 'timeFrame': '60 months', 'description': '5-year disease free survival rate'}, {'measure': 'Sexual function', 'timeFrame': '12 months', 'description': 'International questionnaire of erectile function-5 (IIEF-5)'}, {'measure': 'Sexual function', 'timeFrame': '12 months', 'description': 'Ejaculation function classification'}, {'measure': 'Urinary function', 'timeFrame': '12 months', 'description': 'Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '33234798', 'type': 'DERIVED', 'citation': "Wei B, Zheng Z, Fang J, Xiao J, Han F, Huang M, Xu Q, Wang X, Hong C, Wang G, Ju Y, Su G, Deng H, Zhang J, Li J, Chen T, Huang Y, Huang J, Liu J, Yang X, Wei H; Chinese Postoperative Urogenital Function (PUF) Research Collaboration Group. Effect of Denonvilliers' Fascia Preservation Versus Resection During Laparoscopic Total Mesorectal Excision on Postoperative Urogenital Function of Male Rectal Cancer Patients: Initial Results of Chinese PUF-01 Randomized Clinical Trial. Ann Surg. 2021 Dec 1;274(6):e473-e480. doi: 10.1097/SLA.0000000000004591."}]}, 'descriptionModule': {'briefSummary': "TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).\n\nIn the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a multicenter randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male, 20 \\< age (years) \\< 71, informed consent;\n2. Pathological diagnosis of rectal adenocarcinoma;\n3. Tumors from anal edge 6 \\~ 12 cm (measured by rigid proctoscope);\n4. Preoperative staging T1-4 (T1-2 for anterior rectal wall) N0-2M0 rectal cancer (AJCC- 7th);\n5. R0 TME surgical results is expected;\n6. Preoperative ECOG physical status score 0/1;\n7. Preoperative ASA grade I \\~ III;\n8. Normal urinary function (Bladder residual urine\\<100ml), normal erection function (IIEF-5\\>21) and ejaculation function grading as I level.\n\nExclusion Criteria:\n\n1. Complicated with acute ileus, perforation or hemorrhage;\n2. Tumors with extensive invasion of surrounding tissues, TME not applicable; Imaging examination in regional integration intumescent lymph nodes (maximum diameter 3 cm or higher);\n3. With other malignant diseases or with other malignant disease within 5 years; With other diseases need surgery;\n4. A history of abdominal and pelvic major operation;\n5. People with severe mental illness, or cannot be evaluated due to cultural or psychological factors;\n6. No sexual life;\n7. Critical organ dysfunction, unbearable surgery;\n8. Unstable angina, myocardial infarction, cerebral infarction or hemorrhage within 6 months;\n9. Systemic corticosteroids or immunosuppressive medication history within 1 month;\n10. Pre-existent true incontinence or severe stress urinary incontinence.\n\nExit criteria:\n\n1. Confirmed as M1 during or after operation;\n2. Conversion to abdominoperineal resection (APR)\n3. Postoperatively confirmed as invading rectal intrinsic fascia, or T3 for anterior rectal wall;\n4. Intraoperative confirmed regional lymph node fusion conglobation cannot ensure R0 resection;\n5. Infiltrating major blood vessel and unresectable;\n6. Intraoperative finding other diseases need simultaneous surgery;\n7. Preoperative emergent severe complications, cannot carry out the study treatment;\n8. Emergency surgery is needed;\n9. Into this study, at any stage of the initiative exit or discontinue treatment; Prove to implement the healer violates this research plan.'}, 'identificationModule': {'nctId': 'NCT02435758', 'briefTitle': 'Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'orgStudyIdInfo': {'id': 'PED-PANP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preservation of Denonvilliers Fascia', 'description': 'Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients', 'interventionNames': ['Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery']}, {'type': 'NO_INTERVENTION', 'label': 'Excision of Denonvilliers Fascia', 'description': 'Standard TME surgery (U-shaped excision of Denonvilliers fascia) in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients'}], 'interventions': [{'name': 'Preservation of Denonvilliers Fascia during L-PANP surgery', 'type': 'PROCEDURE', 'description': 'In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia', 'armGroupLabels': ['Preservation of Denonvilliers Fascia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant to the Dean', 'investigatorFullName': 'Hongbo Wei', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}