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Clinical Trials/NCT05195073
NCT05195073CompletedNot Applicable

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

Cairo University1 site in 1 country36 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
The time required to excise the hydrosalpinx

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

3 D laparoscopy group

Active Comparator

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

Intervention: Laparoscopy (Biological)

2 D laparoscopy group

Active Comparator

salpingectomy will be performed by using a conventional 2 D laparoscopy system.

Intervention: Laparoscopy (Biological)

Outcomes

Primary Outcomes

The time required to excise the hydrosalpinx

Time Frame: 6 months

The time required to excise the hydrosalpinx

Secondary Outcomes

  • The amount of Intraoperative blood loss.(6 months)
  • The total operative time.(6 months)
  • Rate of intraoperative and postoperative complications.(6 months)
  • The degree of difficulty experienced by the surgeon(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marwa Mohamed Abdalla

lecturer of Obstetrics and Gynecology

Cairo University

Study Sites (1)

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