This trial is active, not recruiting.

Condition minimally invasive hysterectomy in large uteri
Treatments vaginal hysterectomy, laparoscopic assisted vaginal hysterectomy
Sponsor Ain Shams Maternity Hospital
Start date August 2014
End date May 2016
Trial size 50 participants
Trial identifier NCT02826304, 1


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Vaginal Hysterectomy for uteri larger than 280gm
vaginal hysterectomy
All the cases were performed by the same surgical team Incision is made at the anterior cervical lip below the bladder reflection Anterior peritoneal entry . Douglas pouch entry. The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated . Uterine artery clamping division and ligation After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy 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). Hemostasis The vaginal vault is closed after insertion of intraperitoneal drain and
(Active Comparator)
Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm
laparoscopic assisted vaginal hysterectomy
Uterine manipulator was inserted through the cervix to mobilize the uterus Veress needle was inserted through the base of the umbilicus creation of pneumoperitoneum Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars The round and the utero-ovarian ligament are coagulated and divided. Dissection through the vesico-uterine space to displace bladder away from the cervix. Uterine artery was coagulated and divided laparoscopically anterior colpotomy over the cup of the uterine elevator. 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.

Primary Outcomes

Operative time of the procedure
time frame: Range from 90 minutes to 210 minutes

Secondary Outcomes

Estimated intraoperative blood loss
time frame: the operative time of the procedure which range from 90 minutes to 210 minutes
Hospital costs
time frame: within the period of hospital admission which range from 2 to 8 days
intraoperative complications
time frame: the operative time of the procedure which range from 90 minutes to 210 minutes
Postoperative Pain
time frame: the first 24hrs after the procedure
Postoperative complications
time frame: 1 month after the procedure
postoperative hospital stay
time frame: range from 2 to 7 days

Eligibility Criteria

Female participants from 40 years up to 70 years old.

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.

Additional Information

Official title Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Ain Shams Maternity Hospital.