Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

September 24, 2017 updated by: Ahmed Hamdy Rateb

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
decrease incidence of congenital hernia which associated with undescended testis
Time Frame: 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
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The secondary outcome measure postoperative complication
Time Frame: 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
one week post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahmed Hamdy Rateb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: gamal abdel hamid ahmed, prof, prof of general surgery assuit university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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