Shehata Technique in the Treatment of Intra-abdominal Testis

NCT06862258 | Not Yet Recruiting DMC

• 1 other identifier: INP 2024/063
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on children diagnosed with intra-abdominal cryptorchidism, a condition in which the testicle remains lodged in the abdomen instead of descending to the scrotum. The scrotum is the anatomical area where testicles should reside to maintain their viability and future reproductive function. Treating this condition typically requires one or two surgeries to relocate the testicle to the scrotum while preserving its vital structures, including the vas deferens, veins, and arteries that supply it with blood. In some cases, these structures are long enough to allow for a single surgery, which is referred to as the VILO technique. However, in other cases, the structures may be too short, making it necessary to perform two operations. In the first operation, the testicle is detached and moved to the opposite side of the abdomen while preserving its vital structures. This procedure aims to allow the artery, vein, and vas deferens to elongate over the next 12 weeks with the patient's movement. After this period, a second surgery can safely descend the testicle into the scrotum. This protocol specifically includes children with intra-abdominal testicles who will undergo one of two testicular vessel-preserving techniques: the Shehata technique or the VILO technique. If, during the first laparoscopic surgery, it is determined that the testicle is long enough to be descended safely, the VILO technique will be used to complete the procedure in a single surgery. If the length is insufficient, the Shehata technique will necessitate two surgeries as outlined above. The aim of this scientific research protocol is to prospectively document all clinical and intraoperative characteristics, along with the clinical and ultrasound postoperative evolution of your son, including several months after the final surgery. This study's objective is to evaluate both techniques for successfully relocating the testicle to the scrotum and to prevent any potential damage to the testicle during surge

Conditions

Cryptorchidism

Keywords

Cryptorchidism; Shehata technique; intra-abdominal testis; Vessel Intact Laparoscopic Orchiopexy; testis atrophy

Outcome Measures

Primary Outcomes (1)

• Retraction

  Palpable testicle in the middle or lower third of the scrotum. Measuring scale: dichotomous: present/absent Number of measurements: 3 Measurement tool: Clinical review

  Basal, 12 weeks and 6 months

Secondary Outcomes (1)

• Testicular atrophy

  Basal, 12 weeks and 6 months

Study Arms (1)

intra-abdominal testis

EXPERIMENTAL

This single-arm quasi-experimental study involves subjects aged 6 months to 7 years with intra-abdominal cryptorchidism confirmed by laparoscopy. The subjects will be non-syndromic and may present with unilateral or bilateral cryptorchidism. In the case of a short testicular pedicle, participants will undergo laparoscopic testicular descent while preserving the testicular vessels. A two-stage descent will be performed using the elongation and delayed descent technique (Shehata). Six months post-operation, testicular atrophy (assessed for safety) and the position of the testis within the scrotum (assessed for efficacy) will be evaluated through ultrasonography and clinical examination. Each subject will serve as their own control by comparing outcomes before and after the intervention

Procedure: Shehata technique

Interventions

Shehata technique PROCEDURE

For patients whose intra-abdominal testicle cannot easily reach the contralateral internal inguinal ring due to a short testicular pedicle, the Shehata procedure will be performed. This technique involves a two-stage laparoscopic orchidopexy that preserves the testicular vessels. In the first stage, the intra-abdominal testicle is fixed above the contralateral iliac crest using prolene vascular suture. Twelve weeks later, a second procedure is performed to position the testicle lower. This approach ensures the preservation of the testicular vessels, vas deferens, and overall circulation.

intra-abdominal testis

Eligibility Criteria

• Age: 6 Months - 6 Years
• Gender Eligibility Details: Cryptorchidism in a male disease
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with non-syndromic intra-abdominal cryptorchidism confirmed by laparoscopy.
• Patients from Mexico City or areas close to the city who can attend follow-up

You may not qualify if:

• Patients with other concomitant genital abnormalities (e.g. hypospadias)

Sponsors & Collaborators

• National Institute of Pediatrics, Mexico: lead

Study Sites (1)

Instituto Nacional de Pediatría

Mexico City, Coyoacan, 04530, Mexico

Location

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Silvio Carmona-Librado, MD

  Instituto Nacional de Pediatria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose F Gonzalez-Zamora, PhD

CONTACT

+52 5550687256; jf.gonzalezzamora@gmail.com

Ailema Gonzalez-Ortiz, PhD

CONTACT

+52 5521898316; ailejgo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Quasi-experimental study

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be available in March 2025 for 4 years.
• Access Criteria: The IPD will be shared with the Institutional Research Committees and national regulatory authorities that require it, and, where appropriate, the journal's editorial committee to which the publication is requested. The information will be shared upon written request from the authorities mentioned above.

Locations

ME (1)