Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

Sponsor
Ahmed Hamdy Rateb (Other)
Overall Status
Unknown status
CT.gov ID
NCT03291678
Collaborator
Assiut University (Other)
60
2
11.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: new laparoscopic orchiopexy
  • Procedure: classic laparoscopic orchiopexy
N/A

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 parentsĀ“ 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
one group which is control group will not subjected to internal ring ligation and another group will subjected to closure of the internal ringone group which is control group will not subjected to internal ring ligation and another group will subjected to closure of the internal ring
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique
Anticipated Study Start Date :
Sep 25, 2017
Anticipated Primary Completion Date :
Sep 5, 2018
Anticipated Study Completion Date :
Sep 6, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. decrease incidence of congenital hernia which associated with undescended testis [one year]

    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

Secondary Outcome Measures

  1. The secondary outcome measure postoperative complication [one week post operative]

    close observation of the patient depending on follow up the wound daily ,occurence of edema by observation, good feeding of the patient by mother

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 2 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ahmed Hamdy Rateb
  • Assiut University

Investigators

  • Principal Investigator: gamal abdel hamid ahmed, prof, prof of general surgery assuit university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Hamdy Rateb, resident physician of general surgery assuit university, Assiut University
ClinicalTrials.gov Identifier:
NCT03291678
Other Study ID Numbers:
  • ASSUIT HOSPITAL UNIVERSITY
First Posted:
Sep 25, 2017
Last Update Posted:
Sep 26, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 26, 2017