NCT04528381

Brief Summary

  1. 1.To evaluate the role of laparoscopy in diagnosis \& treatment of Non- palpable undescended testis
  2. 2.To compare between different laparoscopic techniques
  3. 3.To introduce new laparoscopic technique in Assuit university " shehata technique "

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Status
unknown

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

Study Start

First participant enrolled

August 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

August 23, 2020

Last Update Submit

August 23, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Testicular volume

    Achievement of near normal testicular volume

    3 months postoperative

  • Testicular position

    Achievement of of near normal testicular position (at scrotum )

    3 months postoperative

Secondary Outcomes (1)

  • Postoperative complications

    3 months postoperative

Study Arms (1)

Laparoscopy

OTHER

Diagnostic and therapeutic laparoscopy

Procedure: Laparoscopy

Interventions

LaparoscopyPROCEDURE

Laparoscopic orchiopexy

Laparoscopy

Eligibility Criteria

Age3 Months - 6 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • any patient admitted to pediatric unit in Assuit University hospital with non palpable testis ( NPT )below age of 6 years

You may not qualify if:

  • patients with NPT above age of 6 years
  • patients with atrophic or vanishing testis
  • patients with previous failed laparoscopic orchiopexy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Elsherbeny M, Abdallah A, Abouzeid A, Ghanem W, Zaki A. Staged laparoscopic traction orchiopexy for intra-abdominal testis: Is it always feasible? J Pediatr Urol. 2018 Jun;14(3):267.e1-267.e4. doi: 10.1016/j.jpurol.2018.01.021. Epub 2018 Mar 2.

    PMID: 29567012BACKGROUND
  • Shehata S, Shalaby R, Ismail M, Abouheba M, Elrouby A. Staged laparoscopic traction-orchiopexy for intraabdominal testis (Shehata technique): Stretching the limits for preservation of testicular vasculature. J Pediatr Surg. 2016 Feb;51(2):211-5. doi: 10.1016/j.jpedsurg.2015.10.063. Epub 2015 Nov 4.

    PMID: 26655212BACKGROUND
  • Powell C, McIntosh J, Murphy JP, Gatti J. Laparoscopic orchiopexy for intra-abdominal testes-a single institution review. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):481-3. doi: 10.1089/lap.2012.0578. Epub 2013 Apr 6.

    PMID: 23560656BACKGROUND

MeSH Terms

Conditions

Cryptorchidism

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed Abdelfattah

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective \& retrospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at genaral surgery department

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 27, 2020

Study Start

August 1, 2020

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

August 27, 2020

Record last verified: 2020-08