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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hydrosalpinx

Intervention / Treatment
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* Biological: Laparoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3 D laparoscopy group<br>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<br>* 3 D laparoscopy<br>|
| Active Comparator: 2 D laparoscopy group<br>salpingectomy will be performed by using a conventional 2 D laparoscopy system. | Biological: Laparoscopy<br>* 3 D laparoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time required to excise the hydrosalpinx | 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 | 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. | The total operative time. | 6 months | 
| The amount of Intraoperative blood loss. | The amount of Intraoperative blood loss. | 6 months | 
| Rate of intraoperative and postoperative complications. | Rate of intraoperative and postoperative complications. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrosalpinx, Infertility, In vitro fertilization, Laparoscopy