Clinical trial NCT05195073: Three Dimensional Versus Two Dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET
Official title: Three Dimensional Versus Two-dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrosalpinx
Keywords: Hydrosalpinx
Infertility
In vitro fertilization
Laparoscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: The time required to excise the hydrosalpinx
timeFrame: 6 months
Secondary outcomes:
measure: The degree of difficulty experienced by the surgeon
timeFrame: 6 months
measure: The total operative time.
timeFrame: 6 months
measure: The amount of Intraoperative blood loss.
timeFrame: 6 months
measure: Rate of intraoperative and postoperative complications.
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Kasralainy teaching hospital
name: Marwa M Abdalla
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.