Shehata Technique in the Treatment of Intra-abdominal Testis
30 patients around the world
Available in Mexico
BACKGROUND AND STUDY AIMS Cryptorchidism, defined as the absence of one or both testicles
from the scrotum, is the most common congenital genital anomaly identified at birth. The
standard surgical treatment-orchiopexy-involves repositioning the testicle within the
scrotal sac. Approximately 30% of cases involve "non-palpable testicles," which
necessitate diagnostic laparoscopy as the preferred method for both diagnosis and
treatment. A procedure is considered effective and safe when the testicle is successfully
relocated to the scrotum without atrophy.
The most challenging form of cryptorchidism occurs when testicles are intra-abdominal
with short testicular vessels, precluding primary descent. In these cases, the
Fowler-Stephens technique has been developed; it involves dividing the testicular vessels
to permit descent during a second surgical stage. However, this method is not without
complications, with testicular atrophy being one of the most common adverse outcomes.
To address these issues, the Shehata technique was introduced in 2008, demonstrating a
100% success and safety rate in achieving scrotal descent without testicular atrophy.
This impressive outcome relies on an intraoperative maneuver that assesses the vascular
pedicle length, thereby guiding the choice of procedure (VILO vs. Shehata). Nonetheless,
there is currently insufficient evidence to fully validate the significance of this
maneuver. Therefore, the objectives of this study are to evaluate the safety and efficacy
of the Shehata and VILO laparoscopic techniques for the descent of intra-abdominal
testicles.
Who can participate? All patients from 6 months to 7 years of age, with intra-abdominal
cryptorchidism confirmed by laparoscopy, non-syndromic, unilateral or bilateral What does
the study involve? Patients will undergo a laparoscopic descent with preservation of
testicular vessels, either a primary descent (VILO) or by means of the elongation and
delayed descent technique (Shehata). Six months after surgery, testicular atrophy
(safety) and intrascrotal placement (efficacy) will be determined by ultrasound and
clinical examination, with the same subject being monitored before and after the
intervention.
Where is the study run from? Instituto Nacional de Pediatría (México) When is the study
starting and how long is it expected to run for? February 2025 to December 2025 Who is
funding the study? Instituto Nacional de Pediatría (México) Who is the main contact?
Silvio Carmona. Silviodocmor@hotmail.com STUDY DESIGN Study design: Quasi-experimental
study Primary study design: Interventional Secondary study design: Quasi-Experimental
Approach Study setting(s): Hospital Study type: Safety, Efficacy
Participant information sheet Study hypothesis
- The VILO technique will be effective and safe, with a success rate of over 90% and
less than 5% testicular atrophy.
- The Shehata technique will be effective and safe, with a success rate of over 90%
and less than 5% testicular atrophy.
Ethics approval(s) Approved: Dec 10 dic 2025, by Research Committee and Research Ethics
Committee of the Instituto Nacional de Pediatria Number of Registry: 2024/063
Condition: Intrascrotal relocation of the intra-abdominal testicles is essential to
improve the future fertility of patients,.
Intervention: Patients will be recruited from the surgical outpatient clinic with a
diagnosis of cryptorchidism involving a non-palpable testicle. After a medical evaluation
by an attending physician confirming the clinical presentation of a "non-palpable
testicle," these patients will be invited to participate in the study. The parents of the
participants will be informed about the patient's diagnosis, the available diagnostic and
therapeutic options, and the necessary follow-up. The study protocol will include: a
complete blood count, coagulation times, and a preoperative inguino-scrotal ultrasound .
The intraoperative measurement of the vascular pedicle length will determine whether the
VILO or Shehata technique is employed.
VILO Group:
For patients whose intra-abdominal testicle reaches the contralateral internal inguinal
ring without difficulty-and when, with the aid of a second laparoscopic clamp, the
vascular pedicle and vas deferens can be elevated to contact the anterior abdominal wall
, a primary descent will be performed.
Shehata Group:
For testicles that, despite gentle and extensive mobilization, require an attempt to lift
the mesentery until it contacts the abdominal wall, if the resulting length is
insufficient, a staged laparoscopic orchiopexy preserving the testicular vessel described
by will be performed. This procedure involves contralateral fixation of the
intra-abdominal testicle above the contralateral iliac crest using a vascular prolene
suture, thereby preserving the testicular vessels as well as the vas deferens and its
circulation. The procedure is then concluded with the closure of the laparoscopic
incisions, and the patient is transferred to recovery.
Subsequently, a follow-up is scheduled at 12 weeks, preceded by an abdominal Doppler
ultrasound to document the testicle's position and characteristics before the second
surgical stage. During this second laparoscopic stage, once the testicle is located, it
is freed from its fixation to the abdominal wall, and the final elongation of the
vascular pedicle is documented using the same maneuver described by Shehata . The
testicle is then descended through an ipsilateral paravesical neotract until it is
externalized via an incision in the mid-third of the scrotum, where it is secured with
two prolene sutures to the scrotal dartos.
Follow-Up Protocol:
• First Consultation (7-10 days postoperatively): Assessment of the healing of the
laparoscopic incisions and, for those who underwent scrotal orchiopexy, the scrotal
incision.
• Second Consultation (12-13 weeks postoperatively): Evaluation of the preliminary
clinical outcomes regarding testicular position, and exclusion of postoperative
complications such as inguinal hernia, umbilical hernia, and testicular atrophy. An
inguino-scrotal ultrasound will also be performed to determine gonadal size and to
re-measure both inguinal orifices.
• Third Consultation (6 months postoperatively): Clinical review, including a Doppler
ultrasound evaluation to measure testicular volume, dimensions, and to assess for any
abdominal wall defects.
• Fourth Consultation (12 months postoperatively): Clinical review, including a Doppler
ultrasound evaluation to measure testicular volume, dimensions, and to assess for any
abdominal wall defects.
• Annual Follow-Up: Color Doppler ultrasound examinations with testicular measurements
and clinical evaluations.
Primary outcome measure Efficacy will be considered achieved if the corrected testicle
remains in the lower or middle portion of the scrotum.
Safety will be determined by the preservation of more than 75% of the initial volume as
calculated by ultrasound, maintenance of normal vascularity, or as assessed by direct
measurements at the time of descent into the scrotum.
Secondary outcome measures Testicles that are positioned in the high or upper scrotum,
those with a reduction in testicular volume to less than 75% of the original, or those
with abnormalities on color Doppler will be considered as failed corrections.
The overall study start date is 01/01/2025 The overall study end date is 06/01/2027
Eligibility Participant type(s) Patient Age group 6 meses a 7 años de edad Sex Both
Target number of participants 30 Participant inclusion criteria
- 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
Participant exclusion criteria
- Patients with other concomitant genital abnormalities (e.g. hypospadias) Recruitment
start date 02/25/2025 Recruitment end date 01/01/2026
National Institute of Pediatrics, Mexico
1Research sites
30Patients around the world
This study is for people with
Structural Developmental Anomalies of the Male Genital System
Cryptorchidism
Requirements for the patient
To 6 Years
Male
Medical requirements
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.
Patients with other concomitant genital abnormalities.
Sites
Instituto Nacional de Pediatría - México
Avenida de los Insurgentes Sur 3700 letra C, Coyoacán, Insurgentes, Cuicuilco