Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT00003267
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-07-21', 'lastUpdatePostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I cervical cancer', 'stage II cervical cancer', 'stage I vaginal cancer', 'stage II vaginal cancer', 'stage I endometrial carcinoma', 'stage II endometrial carcinoma', 'infection', 'perioperative/postoperative complications'], 'conditions': ['Cervical Cancer', 'Endometrial Cancer', 'Infection', 'Perioperative/Postoperative Complications', 'Vaginal Cancer']}, 'referencesModule': {'references': [{'pmid': '17466514', 'type': 'RESULT', 'citation': 'Franchi M, Trimbos JB, Zanaboni F, v d Velden J, Reed N, Coens C, Teodorovic I, Vergote I. Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients. Eur J Cancer. 2007 May;43(8):1265-8. doi: 10.1016/j.ejca.2007.03.011. Epub 2007 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer.\n\nPURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.', 'detailedDescription': 'OBJECTIVES: I. Evaluate postoperative complications associated with the use or omission of pelvic drains following radical hysterectomy and node dissection that includes suturing of the vaginal cuff and no peritonealization.\n\nOUTLINE: This is a randomized, two-arm study. All patients receive radical hysterectomy (Rutledge-Piver II-III type) and pelvic lymphadenectomy, without pelvic and parietal peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous layers; lumboaortic node dissection is optional. Patients are randomized during surgery to one of two arms: those on arm I receive pelvic drains and those on arm II do not. Those in arm I have drains applied in the pelvis, and lymph is collected by vaginal and/or transabdominal drains located in both retroperitoneal fossa. Drains are removed when the loss is less than 50 mL in 24 hours. Patients in both arms are followed at 2-3 months and 12 months after surgery.\n\nPROJECTED ACCRUAL: 214 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically proven cervical, vaginal, or endometrial carcinoma for which abdominal radical hysterectomy (Rutledge-Piver II or III type) and pelvic node dissection is indicated The following are excluded: Extensive intraoperative retroperitoneal blood loss (more than 3000 mL) Excessive postsurgical hemorrhage or oozing of the wound area requiring postoperative drainage Concurrent urinary or bowel injury/deviation or surgical procedures for urinary incontinence (Burch etc.) Application of prophylactic abdominal mesh for subsequent radiotherapy\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003267', 'briefTitle': 'Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)', 'orgStudyIdInfo': {'id': 'EORTC-55962'}, 'secondaryIdInfos': [{'id': 'EORTC-55962'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'infection prophylaxis and management', 'type': 'PROCEDURE'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}, {'name': 'surgical procedure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1100', 'city': 'Vienna (Wien)', 'country': 'Austria', 'facility': 'Kaiser Franz Josef Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'F-94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': 'D-79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Medical Center', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '25124', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Universita di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '20132', 'city': 'Milano (Milan)', 'country': 'Italy', 'facility': 'Instituto Scientifico H.S. Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milano (Milan)', 'country': 'Italy', 'facility': 'Istituto Nazionale per lo Studio e la Cura dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'University and I.R.C.C.S. Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '27058', 'city': 'Voghera (PV)', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 44.99151, 'lon': 9.01175}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Antoni van Leeuwenhoekhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7500 KA', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '2300 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3508 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '3049', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra (HUC)', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano De Oncologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Sergio L. Pecorelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spedali Civili di Brescia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}