Three Dimensional Versus Two Dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET

August 14, 2023 updated by: Marwa Mohamed Abdalla, Cairo University

Three Dimensional Versus Two-dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET. A Randomized Controlled Trial

A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success. in our study we will compare operative data and early postoperative outcomes of laparoscopic salpingectomy operations conducted using standard 2-D and 3-D laparoscopic vision systems

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy

Exclusion Criteria:

  • Bilateral hydrosalpinx,
  • co-existent adnexal pathology,
  • body mass index (BMI) more than 40,
  • extensive pelvic adhesions,
  • coagulation defects or concurrent anticoagulant therapy,
  • compromised cardiopulmonary status,
  • and contraindications for general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 D laparoscopy group
salpingectomy will be performed by using Storz image 1 S 3D laparoscopy system (Karl Storz, Tuttlingen, Germany) which is comprised of a 10 mm scope with 2 full HD sensors at the tip of the scope and a 3 D control unit plus a 3 D display
Biological: Laparoscopy
3 D laparoscopy
Active Comparator: 2 D laparoscopy group
salpingectomy will be performed by using a conventional 2 D laparoscopy system.
Biological: Laparoscopy
3 D laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time required to excise the hydrosalpinx
Time Frame: 6 months
The time required to excise the hydrosalpinx
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of difficulty experienced by the surgeon
Time Frame: 6 months
The degree of difficulty experienced by the surgeon during excision of the hydrosalpinx [ evaluated using a visual analog scale ranging from 0 (least difficult) to 10 (most difficult)].
6 months
The total operative time.
Time Frame: 6 months
The total operative time.
6 months
The amount of Intraoperative blood loss.
Time Frame: 6 months
The amount of Intraoperative blood loss.
6 months
Rate of intraoperative and postoperative complications.
Time Frame: 6 months
Rate of intraoperative and postoperative complications.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Marwa M Abdalla, Kasralainy teaching hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3D Laparoscopic salpingectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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