Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy

Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy: the Effect of Learning Curve a Randomized Controlled Trial

100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH and effect of learning curve will be assessed by comparing operative time between early and lat patients in TLH group

Study Overview

• Status: Unknown
• Conditions: Effect of Learning Curve on Operative Time in TLH and Comparing it to TAH
• Intervention / Treatment: Procedure: Hystrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 22222
    • Recruiting
    • Ain Shams University
    • Contact: Mohammed Dr Abdelfattah, Lecturer; Phone Number: 01005355324; Email: Abdel_mohsen@live.com
    • Contact: Ahmed Mohsen, lecturer; Phone Number: 01069991411; Email: M.elsenity@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

- Age. More than 40 Uterine size less than 14 weeks No contraindications for laparscopic surgery Benign cause for hystrectomy

Exclusion Criteria:

• virgins Malignancy

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: Total laparscopic hystrectomy	Procedure: Hystrectomy; Total laparscopic hystrectomy versus total abdominal hystrectomy
Experimental: Total abdominal hystrectomy	Procedure: Hystrectomy; Total laparscopic hystrectomy versus total abdominal hystrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Time in both type of hystrectomy will be compared and learning curve will be assesd among TLH group by comparing early cases to late	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss, coplications, postoperative pain	Hb measurment , and visual scale for pain	2 years

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 22, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Total laparoscopic hystrectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Kept with researcher as cds for patients

Drug and device information, study documents

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