Clinical trial NCT02826304: Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri
Official title: Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimally Invasive Hysterectomy in Large Uteri
Keywords: Vaginal Hysterectomy
Laparoscopic assisted vaginal hysterectomy
Large uteri
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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

Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 70 years.
2. 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.
3. Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.

Exclusion Criteria:

1. Patients medically unfit for laparoscopy as severely compromised cardiac patients.
2. Obese patients (BMI\>30).
3. Presence of endometriosis.
4. Previous myomectomy
5. Presence of adnexal mass
6. Known or suspected gynecological malignancy.

Primary outcomes:
measure: Operative time of the procedure
timeFrame: Range from 90 minutes to 210 minutes
Secondary outcomes:
measure: Estimated intraoperative blood loss
timeFrame: the operative time of the procedure which range from 90 minutes to 210 minutes
measure: Hospital costs
timeFrame: within the period of hospital admission which range from 2 to 8 days
measure: intraoperative complications
timeFrame: the operative time of the procedure which range from 90 minutes to 210 minutes
measure: Postoperative Pain
timeFrame: the first 24hrs after the procedure
measure: Postoperative complications
timeFrame: 1 month after the procedure
measure: postoperative hospital stay
timeFrame: range from 24 hours to 168 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maternity hospital, Ain Shams University
Study officials:
affiliation: Ain Shams University Maternity Hospital
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
References:
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.
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.
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.
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.
citation: Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
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.
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.
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.
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.
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.
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.
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.
citation: Teoh TG. Vaginal hysterectomy for the large uterus. Med J Malaysia. 2001 Dec;56(4):460-2.
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.
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.
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.
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.