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

NCT ID: NCT05195073

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-30

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

Conditions

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Hydrosalpinx

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Laparoscopy

Intervention Type BIOLOGICAL

3 D laparoscopy

2 D laparoscopy group

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

Group Type ACTIVE_COMPARATOR

Laparoscopy

Intervention Type BIOLOGICAL

3 D laparoscopy

Interventions

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Laparoscopy

3 D laparoscopy

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Abdalla

lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa M Abdalla

Role: PRINCIPAL_INVESTIGATOR

Kasralainy teaching hospital

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.

Reference Type BACKGROUND
PMID: 20672903 (View on PubMed)

Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.

Reference Type BACKGROUND
PMID: 10548619 (View on PubMed)

Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.

Reference Type BACKGROUND
PMID: 25783650 (View on PubMed)

Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.

Reference Type BACKGROUND
PMID: 20091531 (View on PubMed)

Fouda UM, Elsetohy KA, Elshaer HS. Barbed Versus Conventional Suture: A Randomized Trial for Suturing the Endometrioma Bed After Laparoscopic Excision of Ovarian Endometrioma. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):962-8. doi: 10.1016/j.jmig.2016.06.008. Epub 2016 Jun 18.

Reference Type BACKGROUND
PMID: 27329547 (View on PubMed)

Other Identifiers

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3D Laparoscopic salpingectomy

Identifier Type: -

Identifier Source: org_study_id

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