NCT05195073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

January 4, 2022

Last Update Submit

August 14, 2023

Conditions

Hydrosalpinx

Keywords

HydrosalpinxInfertilityIn vitro fertilizationLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • The time required to excise the hydrosalpinx

    The time required to excise the hydrosalpinx

    6 months

Secondary Outcomes (4)

  • The degree of difficulty experienced by the surgeon

    6 months

  • The total operative time.

    6 months

  • The amount of Intraoperative blood loss.

    6 months

  • Rate of intraoperative and postoperative complications.

    6 months

Study Arms (2)

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

Biological: Laparoscopy

2 D laparoscopy group

ACTIVE COMPARATOR

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

Biological: Laparoscopy

Interventions

LaparoscopyBIOLOGICAL

3 D laparoscopy

2 D laparoscopy group3 D laparoscopy group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 20672903BACKGROUND

  • 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.

    PMID: 10548619BACKGROUND

  • 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.

    PMID: 25783650BACKGROUND

  • 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.

    PMID: 20091531BACKGROUND

  • 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.

    PMID: 27329547BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marwa M Abdalla

    Kasralainy teaching hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

April 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)