Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02826304
Status:
UNKNOWN
Last Update Posted:
2016-07-11
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007045', 'term': 'Hysterectomy, Vaginal'}], 'ancestors': [{'id': 'D007044', 'term': 'Hysterectomy'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time of the procedure', 'timeFrame': 'Range from 90 minutes to 210 minutes', 'description': 'In case of vaginal hysterectomy, the operative time will be measured from the vaginal incision to closure of the vaginal vault. in cases of Laparoscopic assisted vaginal hysterectomy, the time will be measured from the introduction of the laparoscopic camera port till stitching the laparoscopic incisions after ensuring adequate hemostasis. the time of any concomitant procedures was excluded'}], 'secondaryOutcomes': [{'measure': 'Estimated intraoperative blood loss', 'timeFrame': 'the operative time of the procedure which range from 90 minutes to 210 minutes', 'description': 'intraoperative blood loss will be estimated via:\n\n1. \\- amount of blood in suction bottle.\n2. \\- Estimation based on number of soaked gauzes by weighing the gauzes used in the procedure before and after surgery ( each 1mg corresponds to 1ml of blood)\n3. \\- Drop in postoperative hemoglobin and hematocrit when compared with preoperative values.'}, {'measure': 'Hospital costs', 'timeFrame': 'within the period of hospital admission which range from 2 to 8 days', 'description': 'the costs of the following will be calculated:\n\n1. \\- Admission cost which include ward fee, pre and postoperative management costs and extra charges for post surgical complication.\n2. \\- anesthesia cost which includes expenses of anesthetics during the procedure. C)- operation cost which include operative material fee.'}, {'measure': 'intraoperative complications', 'timeFrame': 'the operative time of the procedure which range from 90 minutes to 210 minutes', 'description': '1. \\- need for blood transfusion\n2. \\- need for laparotomy due to either surgical difficulty or any complication\n3. \\- Bowel or urinary tract injuries'}, {'measure': 'Postoperative Pain', 'timeFrame': 'the first 24hrs after the procedure', 'description': 'Postoperative pain will be assessed using the visual analogue scale after the procedure by 6hrs, 12hrs and 24hrs.'}, {'measure': 'Postoperative complications', 'timeFrame': '1 month after the procedure', 'description': '1. \\- Need for blood transfusion\n2. \\- Vaginal vault or pelvic hematoma\n3. \\- surgical site infection\n4. \\- urinary tract infection\n5. \\- postoperative bowel or urinary tract complications'}, {'measure': 'postoperative hospital stay', 'timeFrame': 'range from 24 hours to 168 hours', 'description': 'the hospital stay will be measured in hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vaginal Hysterectomy', 'Laparoscopic assisted vaginal hysterectomy', 'Large uteri'], 'conditions': ['Minimally Invasive Hysterectomy in Large Uteri']}, 'referencesModule': {'references': [{'pmid': '23932973', 'type': 'BACKGROUND', 'citation': 'Cho HY, Park ST, Kim HB, Kang SW, Park SH. Surgical outcome and cost comparison between total vaginal hysterectomy and laparoscopic hysterectomy for uteri weighing >500 g. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):115-9. doi: 10.1016/j.jmig.2013.07.013. Epub 2013 Aug 6.'}, {'pmid': '20666953', 'type': 'BACKGROUND', 'citation': 'Guvenal T, Ozsoy AZ, Kilcik MA, Yanik A. The availability of vaginal hysterectomy in benign gynecologic diseases: a prospective, non-randomized trial. J Obstet Gynaecol Res. 2010 Aug;36(4):832-7. doi: 10.1111/j.1447-0756.2010.01183.x.'}, {'pmid': '16325627', 'type': 'BACKGROUND', 'citation': 'Harb TS, Adam RA. Predicting uterine weight before hysterectomy: ultrasound measurements versus clinical assessment. Am J Obstet Gynecol. 2005 Dec;193(6):2122-5. doi: 10.1016/j.ajog.2005.07.014.'}, {'pmid': '15464771', 'type': 'BACKGROUND', 'citation': 'Harmanli OH, Gentzler CK, Byun S, Dandolu MH, Grody T. A comparison of abdominal and vaginal hysterectomy for the large uterus. Int J Gynaecol Obstet. 2004 Oct;87(1):19-23. doi: 10.1016/j.ijgo.2004.06.018.'}, {'pmid': '11129939', 'type': 'BACKGROUND', 'citation': 'Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.'}, {'pmid': '7778623', 'type': 'BACKGROUND', 'citation': 'Johns DA, Carrera B, Jones J, DeLeon F, Vincent R, Safely C. The medical and economic impact of laparoscopically assisted vaginal hysterectomy in a large, metropolitan, not-for-profit hospital. Am J Obstet Gynecol. 1995 Jun;172(6):1709-15; discussion 1715-9. doi: 10.1016/0002-9378(95)91402-1.'}, {'pmid': '20598052', 'type': 'BACKGROUND', 'citation': 'Kim HB, Song JE, Kim GH, Cho HY, Lee KY. Comparison of clinical effects between total vaginal hysterectomy and total laparoscopic hysterectomy on large uteruses over 300 grams. J Obstet Gynaecol Res. 2010 Jun;36(3):656-60. doi: 10.1111/j.1447-0756.2010.01185.x.'}, {'pmid': '16934269', 'type': 'BACKGROUND', 'citation': 'Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.'}, {'pmid': '14616278', 'type': 'BACKGROUND', 'citation': 'Nazah I, Robin F, Jais JP, Jeffry L, Lelievre L, Camatte S, Taurelle R, Lecuru F. Comparison between bisection/morcellation and myometrial coring for reducing large uteri during vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy: results of a randomized prospective study. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1037-42. doi: 10.1034/j.1600-0412.2003.00278.x.'}, {'pmid': '17963064', 'type': 'BACKGROUND', 'citation': "Sahin Y. Vaginal hysterectomy and oophorectomy in women with 12-20 weeks' size uterus. Acta Obstet Gynecol Scand. 2007;86(11):1359-69. doi: 10.1080/00016340701657258."}, {'pmid': '12101331', 'type': 'BACKGROUND', 'citation': 'Seracchioli R, Venturoli S, Vianello F, Govoni F, Cantarelli M, Gualerzi B, Colombo FM. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002 Aug;9(3):333-8. doi: 10.1016/s1074-3804(05)60413-6.'}, {'pmid': '22776300', 'type': 'BACKGROUND', 'citation': 'Shiota M, Kotani Y, Umemoto M, Tobiume T, Shimaoka M, Hoshiai H. Total abdominal hysterectomy versus laparoscopically-assisted vaginal hysterectomy versus total vaginal hysterectomy. Asian J Endosc Surg. 2011 Nov;4(4):161-5. doi: 10.1111/j.1758-5910.2011.00104.x. Epub 2011 Sep 8.'}, {'pmid': '12014766', 'type': 'BACKGROUND', 'citation': 'Teoh TG. Vaginal hysterectomy for the large uterus. Med J Malaysia. 2001 Dec;56(4):460-2.'}, {'pmid': '15262360', 'type': 'BACKGROUND', 'citation': 'Wang CJ, Yen CF, Lee CL, Tashi T, Soong YK. Laparoscopically assisted vaginal hysterectomy for large uterus: a comparative study. Eur J Obstet Gynecol Reprod Biol. 2004 Aug 10;115(2):219-23. doi: 10.1016/j.ejogrb.2003.12.021.'}, {'pmid': '15559351', 'type': 'BACKGROUND', 'citation': 'Wang CJ, Yuen LT, Yen CF, Lee CL, Soong YK. A simplified method to decrease operative blood loss in laparoscopic-assisted vaginal hysterectomy for the large uterus. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):370-3. doi: 10.1016/s1074-3804(05)60053-9.'}, {'pmid': '11821608', 'type': 'BACKGROUND', 'citation': 'Yen YK, Liu WM, Yuan CC, Ng HT. Comparison of two procedures for laparoscopic-assisted vaginal hysterectomy of large myomatous uteri. J Am Assoc Gynecol Laparosc. 2002 Feb;9(1):63-9. doi: 10.1016/s1074-3804(05)60106-5.'}, {'pmid': '28508344', 'type': 'DERIVED', 'citation': 'Mohammed WE, Salama F, Tharwat A, Mohamed I, ElMaraghy A. Vaginal hysterectomy versus laparoscopically assisted vaginal hysterectomy for large uteri between 280 and 700 g: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jul;296(1):77-83. doi: 10.1007/s00404-017-4397-6. Epub 2017 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes', 'detailedDescription': 'Study setting : Ain Shams University Maternity Hospital Study Design : Pilot prospective randomized clinical trial Study population: The patients will be recruited from women presenting to the outpatient clinic of Ain Shams University Maternity Hospital planned to undergo hysterectomy for benign cause according to inclusion/ exclusion criteria which will be mentioned later.\n\nStudy duration : the study will be carried out during the period from August 2014 to August 2016.\n\nSample size: total of 50 cases will be included in the study to be divided into two groups, the first group will undergo vaginal hysterectomy and the second will undergo Laparoscopic assisted vaginal hysterectomy.\n\nintervention: after approval of the ethical committee, a detailed explanation of the procedure will be informed to the participant and after her approval to involve in the study, an informed written consent will be taken. Detailed medical history will be obtained from all participants recruited in the study along with complete clinical examination and necessary laboratory and radiological investigations. Each patient will have a case record form in which the data regarding history, examination, investigations, operation costs and postoperative events will be recorded'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 40 and 70 years.\n2. Uterine weight more than 280gm. the weight will be estimated sonographically using algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)= 50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the dome of the fundus to the level of the external os and (W) is the maximum width of the uterus at the level of the cornua and (AP) is the anteroposterior diameter of the uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine length.\n3. Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.\n\nExclusion Criteria:\n\n1. Patients medically unfit for laparoscopy as severely compromised cardiac patients.\n2. Obese patients (BMI\\>30).\n3. Presence of endometriosis.\n4. Previous myomectomy\n5. Presence of adnexal mass\n6. Known or suspected gynecological malignancy.'}, 'identificationModule': {'nctId': 'NCT02826304', 'briefTitle': 'Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VH', 'description': 'Vaginal Hysterectomy for uteri larger than 280gm', 'interventionNames': ['Procedure: Vaginal hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LAVH', 'description': 'Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm', 'interventionNames': ['Procedure: Laparoscopic assisted vaginal hysterectomy']}], 'interventions': [{'name': 'Vaginal hysterectomy', 'type': 'PROCEDURE', 'description': 'All the cases were performed by the same surgical team\n\n1. Incision is made at the anterior cervical lip below the bladder reflection\n2. Anterior peritoneal entry .\n3. Douglas pouch entry.\n4. The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated .\n5. Uterine artery clamping division and ligation\n6. After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy\n7. Utero-ovarian and round clamping-division and ligation ( in cases where oophorectomy was performed this part was done at the level of the infundibulo-pelvic ligament).\n8. Hemostasis\n9. The vaginal vault is closed after insertion of intraperitoneal drain and', 'armGroupLabels': ['VH']}, {'name': 'Laparoscopic assisted vaginal hysterectomy', 'type': 'PROCEDURE', 'description': '1. Uterine manipulator was inserted through the cervix to mobilize the uterus\n2. Veress needle was inserted through the base of the umbilicus\n3. creation of pneumoperitoneum\n4. Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars\n5. The round and the utero-ovarian ligament are coagulated and divided.\n6. Dissection through the vesico-uterine space to displace bladder away from the cervix.\n7. Uterine artery was coagulated and divided laparoscopically\n8. anterior colpotomy over the cup of the uterine elevator.\n9. Vaginal part starts with opening of douglas pouch and clamping , division and ligation of uterosacral and cardinal ligaments followed by removal of the uterus and closure of the vault. reinflation to ensure proper hemostasis.', 'armGroupLabels': ['LAVH']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Maternity hospital, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Fekrya A Salama, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University Maternity Hospital'}, {'name': 'Ahmed A Tharwat, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University Maternity Hospital'}, {'name': 'Walid E Mohamed, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University Maternity Hospital'}, {'name': 'Ibrahim M Ibrahim, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University Maternity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in obstetrics and gynecology', 'investigatorFullName': 'Ibrahim Mohamed Ibrahim Ali', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}