Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04528381
Collaborator
(none)
100
1
26

Study Details

Study Description

Brief Summary

  1. To evaluate the role of laparoscopy in diagnosis & treatment of Non- palpable undescended testis

  2. To compare between different laparoscopic techniques

  3. To introduce new laparoscopic technique in Assuit university " shehata technique "

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopy
N/A

Detailed Description

Cryptorchidism or undescended testis (UDT) is one of the most common genital anomalies in childhood. Its incidence is 3-5 % in full term newborn, and affect more than one third of premature newborn. The incidence decrease to 1 % at age of 3months. About 20% of UDT are impalpable, and about 50% of these impalpable testes are either vanished or atrophic (1-3).

Many diagnostic methods have been used for the evaluation and management of the undescended testis, including imaging studies and multiple surgical procedures.

Surgical management of UDT is performed to preserve testicular function (spermatogenesis) and to prevent the potential complications of undescended testis(1).

Regarding the optimal age of orchiopexy many recent findings suggest that early intervention (6 -12 months of age) is most beneficial. Other findings suggest that there is high rate of spontaneous descent during the first 3 months of life, so observation of undescended testis is advocated till 3 months of age, if the testis remains non-palpable at 3 months of age, it is unlikely to become palpable by waiting another 3 months. Therefore, diagnostic laparoscopy and orchidopexy could be performed from 3 months of age(2).

For intraabdominal cryptorchidism, laparoscopic surgery has been accepted by most surgeons as the preferred technique for diagnosis & treatment (4).

Laparoscopic findings in non-palpable testis include ; Absent testis either ; Agenesis ( absence of spermatic vessels and vas deferens ) or vanishing testis ( blind ending of spermatic vessels or vas ) , Canalicular testis ; Penetration of vas and spermatic vessels into the internal inguinal ring with or without directly seeing the testis , Abdominal testis Localized between the inferior renal pole and the ipsilateral internal inguinal ring. Can be low (< 2cm) or high (>2cm) from internal inguinal ring , Peeping ; Primarily in intra-abdominal position. The testis introduces itself into the inguinal canal due to the intra-abdominal pressure augmentation during the laparoscopic procedure.(5)

Several techniques have been described for treatment of intra-abdominal testis including microsurgical auto-transplantation, primary laparoscopic orchiopexy (VILO), one- and two-stage laparoscopic Fowler-Stephens procedures, and staged laparoscopic traction orchiopexy (Shehata technique

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective & retrospectiveProspective & retrospective
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Laparoscopy in Management of Non-palpable Undescended Testis : Assuit University Experience
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Laparoscopy

Diagnostic and therapeutic laparoscopy

Procedure: Laparoscopy
Laparoscopic orchiopexy

Outcome Measures

Primary Outcome Measures

  1. Testicular volume [3 months postoperative]

    Achievement of near normal testicular volume

  2. Testicular position [3 months postoperative]

    Achievement of of near normal testicular position (at scrotum )

Secondary Outcome Measures

  1. Postoperative complications [3 months postoperative]

    Bleeding , damage of vas and/or blood supply and reascent

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 6 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • any patient admitted to pediatric unit in Assuit University hospital with non palpable testis ( NPT )below age of 6 years
Exclusion Criteria:
  • patients with NPT above age of 6 years

  • patients with atrophic or vanishing testis

  • patients with previous failed laparoscopic orchiopexy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Abdelfattah, Resident at genaral surgery department, Assiut University
ClinicalTrials.gov Identifier:
NCT04528381
Other Study ID Numbers:
  • Laparoscopy in NPT
First Posted:
Aug 27, 2020
Last Update Posted:
Aug 27, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2020