Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri

NCT02826304 | Unknown DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Minimally Invasive Hysterectomy in Large Uteri

Keywords

Vaginal Hysterectomy; Laparoscopic assisted vaginal hysterectomy; Large uteri

Outcome Measures

Primary Outcomes (1)

• Operative time of the procedure

  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

  Range from 90 minutes to 210 minutes

Secondary Outcomes (6)

• Estimated intraoperative blood loss

  the operative time of the procedure which range from 90 minutes to 210 minutes

• Hospital costs

  within the period of hospital admission which range from 2 to 8 days

• intraoperative complications

  the operative time of the procedure which range from 90 minutes to 210 minutes

• Postoperative Pain

  the first 24hrs after the procedure

• Postoperative complications

  1 month after the procedure

Study Arms (2)

VH

ACTIVE COMPARATOR

Vaginal Hysterectomy for uteri larger than 280gm

Procedure: Vaginal hysterectomy

LAVH

ACTIVE COMPARATOR

Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm

Procedure: Laparoscopic assisted vaginal hysterectomy

Interventions

Vaginal hysterectomy PROCEDURE

All the cases were performed by the same surgical team 1. Incision is made at the anterior cervical lip below the bladder reflection 2. Anterior peritoneal entry . 3. Douglas pouch entry. 4. The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated . 5. Uterine artery clamping division and ligation 6. After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy 7. 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). 8. Hemostasis 9. The vaginal vault is closed after insertion of intraperitoneal drain and

VH

Laparoscopic assisted vaginal hysterectomy PROCEDURE

1. Uterine manipulator was inserted through the cervix to mobilize the uterus 2. Veress needle was inserted through the base of the umbilicus 3. creation of pneumoperitoneum 4. Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars 5. The round and the utero-ovarian ligament are coagulated and divided. 6. Dissection through the vesico-uterine space to displace bladder away from the cervix. 7. Uterine artery was coagulated and divided laparoscopically 8. anterior colpotomy over the cup of the uterine elevator. 9. 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.

LAVH

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Maternity hospital, Ain Shams University

Cairo, Egypt

Location

Related Publications (17)

• 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: 23932973 BACKGROUND

• 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: 20666953 BACKGROUND

• 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: 16325627 BACKGROUND

• 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: 15464771 BACKGROUND

• Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.

  PMID: 11129939 BACKGROUND

• 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: 7778623 BACKGROUND

• 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: 20598052 BACKGROUND

• 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: 16934269 BACKGROUND

• 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: 14616278 BACKGROUND

• 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: 17963064 BACKGROUND

• 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: 12101331 BACKGROUND

• 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: 22776300 BACKGROUND

• Teoh TG. Vaginal hysterectomy for the large uterus. Med J Malaysia. 2001 Dec;56(4):460-2.

  PMID: 12014766 BACKGROUND

• 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: 15262360 BACKGROUND

• 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: 15559351 BACKGROUND

• 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: 11821608 BACKGROUND

• 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.

  PMID: 28508344 DERIVED

MeSH Terms

Interventions

Hysterectomy, Vaginal

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Fekrya A Salama, PhD

  Ain Shams University Maternity Hospital

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 7, 2016
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)