Shehata Technique in the Treatment of Intra-abdominal Testis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-6
SponsorNational Institute of Pediatrics, Mexico

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with non-syndromic intra-abdominal cryptorchidism confirmed by laparoscopy.

Patients whose parents or guardians sign an informed consent form for their inclusion.

Patients from Mexico City or areas close to the city who can attend follow-up

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Shehata technique

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: intra-abdominal testisExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Basal, 12 weeks and 6 months

Secondary outcomes

1

Testicular atrophy

Measuring scale: dichotomous: present/absent Number of measurements: 3 Measurement tool: The volume of both testicles in mm3 calculated by USG Doppler. Testicular atrophy is present if there is a difference of more than 25% in volume when comparing a healthy testicle with the affected one. Additionally, if the volume of the operated testicle decreases by more than 50% during monitoring, this also indicates testicular atrophy.

Time frame
Basal, 12 weeks and 6 months

Other outcomes

Sponsors and contacts

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