Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique

Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia

Study Overview

• Status: Unknown
• Conditions: Congenital Disorders
• Intervention / Treatment: Procedure: new laparoscopic orchiopexy; Procedure: classic laparoscopic orchiopexy

Detailed Description

Cryptorchidism is the most common genitourinary anomaly in male children. Its incidence can reach 3% in full term neonates, rising to 30% in premature boys . The treatment of the crypt orchid testicle is justified by the increased risk of infertility and malignancy, as well as an associated inguinal hernia and the risk of trauma to the ectopic testicle against the pubis. Furthermore, the psychological stigma of a missing testis for the patient, as well as the parents' anxiety is also factors that justify this type of treatment .

About 20% of crypt orchid testicles are non palpable. The treatment of non-descended testicles is mandatory due to the increased risk of infertility, present in up to 40% of the patients, as compared to 6% of control groups, including malignancy, which reaches 20 times that of normal adults .

The treatment of the crypt orchid testis before 2 years of age is recommended, treatment is necessary not only for the risk of malignancy, but also for the satisfaction and improvement in the quality of the patient's life and parents´ concern for their children's health.

In relation to diagnosis, despite a sensitivity of 70-90% in the diagnosis of inguinal testes, ultrasonography is not useful in intra-abdominal cases . Although presenting a better quality, both computed tomography and nuclear magnetic resonance lack sufficient sensitivity and specificity to be considered as gold standard diagnostic tools . More recently, the magnetic angioresonance was introduced with sensibility of 96% and specificity of 100%, but it is still a new method, with high costs, also requiring general anesthesia in children .

In relation to the treatment, the use of gonadotrophin for un descended testes presents a success rate of definitive descent to the scrotum of 21 to 56%, with better results in bilateral cases . Surgical treatment via an inguinal incision is the main treatment option for palpable testicles, but can also be employed for the evaluation and treatment of non-palpable testis. In this situation, however, surgical exploration can often require large incisions and extensive dissections, especially in bilateral cases. This can be avoided using laparoscopic evaluation, with a sensitivity and specificity reaching more than 90%

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed mohammed soliaman, dr; Phone Number: 0201091672661; Email: ahmed.ali15@med.au.edu.eg
• Study Contact Backup: Name: mohamed abdelkader osman, prof; Phone Number: 0201090266780; Email: osman@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

• INCLUSION CRITERIA

  1. Age above six months
  2. SEX must be male
  3. Surgical approach is closure of internal ring via percutaneous technique after delivery of undescended testis

• EXCLUSION CRITERIA

  1. Age less than 3 months
  2. Patients with palpable undescended testis
  3. Any associated major congenital anomalies like cardiac anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: new laparoscopic orchiopexy; this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring	Procedure: new laparoscopic orchiopexy; closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
Active Comparator: classic laparoscopic orchoipexy; this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum	Procedure: classic laparoscopic orchiopexy; delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease incidence of congenital hernia which associated with undescended testis	patient follow up will be after 15 days and then after two months by examination of the operation site ,stitches , and hernial orifices to be sure of absence of congenital hernia	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome measure postoperative complication	close observation of the patient depending on follow up the wound daily ,occurence of edema by observation, good feeding of the patient by mother	one week post operative

Collaborators and Investigators

• Sponsor: Ahmed Hamdy Rateb
• Collaborators: Assiut University
• Investigators: Principal Investigator: gamal abdel hamid ahmed, prof, prof of general surgery assuit university

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2017
• Primary Completion (Anticipated): September 5, 2018
• Study Completion (Anticipated): September 6, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 24, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ASSUIT HOSPITAL UNIVERSITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No