Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
Condition: Testes Undescend
MeSH terms: Cryptorchidism
Study type: Interventional

Summary: 
      Undescended testes (UDTs) are a relatively common finding in pediatrics with prevalence about
      1-2% in newborns. Upon discovering a non-intrascrotal testis, it is important to determine
      whether the testis is palpable or non-palpable (1). A canalicular or 'emergent' testis may be
      impalpable initially and may be appear when it is 'milked' out of the inguinal canal (where
      it is concealed from detection) indicating that 15 to 40% of cryptorchidism are viable
      peeping/canalicular testis.

      The laparoscopic approach for treating canalicular undescended testes offers many advantages
      over open inguinal orchiopexy. The laparoscopic technique maintains the integrity of the
      inguinal canal anatomy and eliminating the need to divide the epigastric vessels during
      dissection. The ability to dissect the testicular vessels at a higher extent would increase
      the vessel length available to lower the testis without strain.

        -  This is a prospective study will be conducted at Department of Pediatric Surgery, MCH
           hospital, Bisha, Saudia Arabia and Pediatric surgery Department , Al-Azhar University
           hospitals, Cairo, Egypt, from January 2019 to October 2020 to evaluate the safety and
           efficiency of laparoscopic orchiopexy of intracanalicular testis.

        -  Patients' age and laterality will be reported. Evaluation will be done for the operative
           difficulties, intraoperative complications, operative time and early postoperative
           complications.

      Testicular site, size and vascularity will be evaluated by ultrasonography at 6th month post
      operatively. Also, cosmetic results will be evaluated by obtaining the parent's questioners
      at post-operative OPD clinic visits.

      - Laparoscopic orchiopexy for management of inguinal canalicular undescended testes is a
      safe, effective, and less invasive, without disturbance of inguinal canal anatomy, with
      better cosmetic results.
    

Detailed description: 
      Aim of the study:

      Herein, the study aims to evaluate the laparoscopic procedure for management of canalicular
      testis regarding operative safety, efficacy and post-operative outcomes.

      Brief review of literature:

        -  Different management modalities for intra-canalicular (emergent) testes in male children
           (open surgery, Laparoscopy).

        -  Advantages of laparoscopic orchiopexy for intra-canalicular (emergent) testes.

      Patients and Methods:

      This is a prospective study, will be conducted out at pediatric surgery tertiary centers
      (Maternity & Children's Hospital in Bisha, KSA and Al-Azhar University hospitals in Cairo,
      Egypt) on pediatric patients presenting at the pediatric surgery OPD clinic by
      intra-canalicular (emergent/peeping) testes in the period from January 2019 to October 2020.
      Enrolled patients will be managed by laparoscopic orchiopexy. All patients enrolled in the
      study will give a written informed consent. The study will be approved by the Institutional
      Review Board and ethics committee of the hospitals. The main objective is to assess safety
      and efficacy of laparoscopic orchiopexy for intra-canalicular (emergent/peeping) testes in
      male patients.

      Institutes of the study:

      A multicenter study at Pediatric Surgery Departments, Maternity & Children's hospital in
      Bisha, KSA and Al-Azhar University hospitals in Cairo.

      Number of cases: Sixty two male children. Time frame: period of 1.10 years.

      Ethical Consideration:

      The protocol will be discussed and approved for clinical study by the Ethical Research
      Committee at MCH at Bisha, KSA, and other participating hospitals. The procedures and the aim
      of the study will be clearly explained to the patient and the family. A written informed
      consent will be obtained before enrollment of the patients into the study. The family refusal
      to give consent for laparoscopic management is respected but does not deprive the patient
      from getting open orchiopexy.

      Preoperative preparation:

      Proper examination done for patients using flat and frog leg position with gentile squeezing
      of testis down, proved by preoperative inguinoscrotal ultrasonography.

      Follow-up:

      Patients will be reviewed at the OPD clinic. Patients who could not attend the clinic will be
      contacted by phone. Postoperative Doppler ultrasonography will be done to assess testicular
      size and vascularity. Questionnaire will be obtained from the parents to assess their
      cosmetic satisfaction.

      Statistical analysis:

      It will be performed with IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM
      Corp. Data will be presented as mean, standard deviation, number & percentage, using
      Chi-squared test (X2) for qualitative data. The significance level will be set at P > 0.05.

      - Discussion will focus on laparoscopic management of intra-canalicular (emergent) testes.
      The results obtained from this study will be compared with each other and with that reported
      in the literature. The discussion will focus on operative details, operative time, results, &
      complications.

      It will compare results of this study with the results of others. Discussion will determine
      the most accurate management modality for intra-canalicular (emergent) testes in male
      children which offers the best outcome and least morbidity.
    

Intervention name(s): laparoscopic orchiopexy for intra-canalicular testis
Intervention type(s): Procedure
Intervention description(s): laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis
Intervention model: Single Group Assignment
Intervention model description: This is a prospective study conducted to evaluate the safety and efficiency of laparoscopic orchiopexy of intra-canalicular (emergent/peeping) testis.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic,; orchiopexy,; intracanalicuar testes,; peeping testes