Laparoscopic Assisted Doderlin Vaginal Hysterectomy

Laparoscopic Assisted Doderlin Vaginal Hysterectomy vs. Laparoscopic Assisted Vaginal Hysterectomy: A Randomized Clinical Trial.

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)

Study Overview

• Status: Completed
• Conditions: Laparoscopic Hysterectomy
• Intervention / Treatment: Procedure: Laparoscopic hysterectomy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LAVH; Laparoscopic Assisted Vaginal Hysterectomy	Procedure: Laparoscopic hysterectomy; Laparoscopic hysterectomy; Other Names: Laparoscopic Assisted Hysterectomy
Active Comparator: LADH; Laparoscopic Assisted Doderlin Vaginal Hysterectomy	Procedure: Laparoscopic hysterectomy; Laparoscopic hysterectomy; Other Names: Laparoscopic Assisted Hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Operative time	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss		24 hours
postoperative pain	questionnaire using Visual Analogue scale	24 hours
operative complications		24 hours
Hospital stay		24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2017
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: April 30, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AS1393

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No