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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Minimally Invasive Hysterectomy in Large Uteri

Interventions

Type	Name	Description
PROCEDURE	Vaginal hysterectomy	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
PROCEDURE	Laparoscopic assisted vaginal hysterectomy	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2016-07-07
• Last updated: 2016-07-11

Locations

1 site across 1 country: Egypt