Laparoscopic Assisted Doderlin Vaginal Hysterectomy

Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144414
• Other study ID #: AS1393
• Status: Completed
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: January 20, 2020

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 20, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy

Intervention

Procedure:
• Laparoscopic hysterectomy
Laparoscopic hysterectomy

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time		24 hours
Secondary	postoperative pain	questionnaire using Visual Analogue scale	24 hours
Secondary	operative complications		24 hours
Secondary	Hospital stay		24 hours
Secondary	Blood loss		24 hours