Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
Primary Purpose
We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina
Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic orchiopexy
Sponsored by
About this trial
This is an interventional diagnostic trial for We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina focused on measuring laparoscopy , open , orchiopexy
Eligibility Criteria
Inclusion Criteria: all children presented with high inguinal undescended testis Exclusion Criteria: previous inguinal surgery unfit patients
Sites / Locations
- South Valley University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laparoscopic orchiopexy
open orchiopexy
Arm Description
laparoscopic orchiopexy group
open orchiopexy group
Outcomes
Primary Outcome Measures
success of laparoscopy and open surgery in treatment of high inguinal testis
assess the outcome and success rate of laparoscopy and open surgery in treatment of high inguinal testis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05845515
Brief Title
Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
Official Title
Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.
All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.
We exclude children with previous history of inguinal surgery or unfit for anesthesia.
150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.
All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal & colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.
Detailed Description
Cryptorchidism, or undescended testis, is a common congenital anomaly in male child, it accounts 1 to 4.6% of full-term infants at the age of 1 year.
This condition usually involves the testicle that fail to travel from the abdomen through the inguinal canal to the scrotum during fetal life., cryptorchidism usually classified as inguinal cryptorchidism and intra-abdominal cryptorchidism in clinical practice, about 80% of undescended testis can feel the testis in the inguinal canal (1).
Cryptorchidism more than 6 months needs orchiopexy. Although laparoscopy has used widely in management of intra-abdominal cryptorchidism, there were controversy for its use in the treatment of inguinal cryptorchidism (1).
Open surgical treatment of such high inguinal testes is the most popular approach among urologists. Due to the difficult surgical mobilization of some high inguinal testes, as well as significant complications, including testicular retraction/atrophy (3-18%), we hypothesized in this study that laparoscopic orchiopexy for such high inguinal testes will be an attractive alternative approach (2).
Patients and methods
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.
All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.
We exclude children with previous history of inguinal surgery or unfit for anesthesia.
150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.
All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal & colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina
Keywords
laparoscopy , open , orchiopexy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic orchiopexy
Arm Type
Active Comparator
Arm Description
laparoscopic orchiopexy group
Arm Title
open orchiopexy
Arm Type
Active Comparator
Arm Description
open orchiopexy group
Intervention Type
Procedure
Intervention Name(s)
laparoscopic orchiopexy
Intervention Description
laparoscopic or open orchiopexy and comparison between the two groups
Primary Outcome Measure Information:
Title
success of laparoscopy and open surgery in treatment of high inguinal testis
Description
assess the outcome and success rate of laparoscopy and open surgery in treatment of high inguinal testis
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all children presented with high inguinal undescended testis
Exclusion Criteria:
previous inguinal surgery
unfit patients
Facility Information:
Facility Name
South Valley University
City
Qinā
State/Province
Qina
ZIP/Postal Code
831115
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
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