- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826304
Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri
Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study duration : the study will be carried out during the period from August 2014 to August 2016.
Sample 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.
intervention: 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Maternity hospital, Ain Shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 40 and 70 years.
- 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.
- Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.
Exclusion Criteria:
- Patients medically unfit for laparoscopy as severely compromised cardiac patients.
- Obese patients (BMI>30).
- Presence of endometriosis.
- Previous myomectomy
- Presence of adnexal mass
- Known or suspected gynecological malignancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VH
Vaginal Hysterectomy for uteri larger than 280gm
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All the cases were performed by the same surgical team
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Active Comparator: LAVH
Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time of the procedure
Time Frame: Range from 90 minutes to 210 minutes
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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
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Range from 90 minutes to 210 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated intraoperative blood loss
Time Frame: the operative time of the procedure which range from 90 minutes to 210 minutes
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intraoperative blood loss will be estimated via:
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the operative time of the procedure which range from 90 minutes to 210 minutes
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Hospital costs
Time Frame: within the period of hospital admission which range from 2 to 8 days
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the costs of the following will be calculated:
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within the period of hospital admission which range from 2 to 8 days
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intraoperative complications
Time Frame: the operative time of the procedure which range from 90 minutes to 210 minutes
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the operative time of the procedure which range from 90 minutes to 210 minutes
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Postoperative Pain
Time Frame: the first 24hrs after the procedure
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Postoperative pain will be assessed using the visual analogue scale after the procedure by 6hrs, 12hrs and 24hrs.
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the first 24hrs after the procedure
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Postoperative complications
Time Frame: 1 month after the procedure
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1 month after the procedure
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postoperative hospital stay
Time Frame: range from 24 hours to 168 hours
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the hospital stay will be measured in hours
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range from 24 hours to 168 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Fekrya A Salama, PhD, Ain shams university maternity hospital
- Study Director: Ahmed A Tharwat, PhD, Ain shams university maternity hospital
- Study Director: Walid E Mohamed, PhD, Ain shams university maternity hospital
- Study Director: Ibrahim M Ibrahim, PhD, Ain shams university maternity hospital
Publications and helpful links
General Publications
- 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.
- Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Teoh TG. Vaginal hysterectomy for the large uterus. Med J Malaysia. 2001 Dec;56(4):460-2.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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