NCT03144414

Brief Summary

This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

May 20, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

April 30, 2017

Last Update Submit

January 26, 2020

Conditions

Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Operative time

    24 hours

Secondary Outcomes (4)

  • postoperative pain

    24 hours

  • operative complications

    24 hours

  • Hospital stay

    24 hours

  • Blood loss

    24 hours

Study Arms (2)

LAVH

ACTIVE COMPARATOR

Laparoscopic Assisted Vaginal Hysterectomy

Procedure: Laparoscopic hysterectomy

LADH

ACTIVE COMPARATOR

Laparoscopic Assisted Doderlin Vaginal Hysterectomy

Procedure: Laparoscopic hysterectomy

Interventions

Laparoscopic hysterectomyPROCEDURE

Laparoscopic hysterectomy

Also known as: Laparoscopic Assisted Hysterectomy
LADHLAVH

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 40 years.
  • Uterine size ≤ 14weeks.
  • Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse).
  • No contraindication for laparoscopic surgery.

You may not qualify if:

  • Gynecologic malignancy.
  • Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
  • Large abdominal hernia
  • Large ovarian mass
  • History of previous laparotomy finding extensive adhesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

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
Assistant Professor

Study Record Dates

First Submitted

April 30, 2017

First Posted

May 8, 2017

Study Start

May 20, 2017

Primary Completion

January 10, 2020

Study Completion

January 20, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)