Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

NCT03291678 | Unknown DMC

• 1 other identifier: ASSUIT HOSPITAL UNIVERSITY
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Congenital Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary outcome measure postoperative complication

  one week post operative

Study Arms (2)

new laparoscopic orchiopexy

EXPERIMENTAL

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

classic laparoscopic orchoipexy

ACTIVE COMPARATOR

this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum

Procedure: classic laparoscopic orchiopexy

Interventions

new laparoscopic orchiopexy PROCEDURE

closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous

new laparoscopic orchiopexy

classic laparoscopic orchiopexy PROCEDURE

delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal

classic laparoscopic orchoipexy

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ahmed Hamdy Rateb: lead
• Assiut University: collaborator

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• gamal abdel hamid ahmed, prof

  prof of general surgery assuit university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed mohammed soliaman, dr

CONTACT

0201091672661; ahmed.ali15@med.au.edu.eg

mohamed abdelkader osman, prof

CONTACT

0201090266780; osman@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident physician of general surgery assuit university

Model Details: one group which is control group will not subjected to internal ring ligation and another group will subjected to closure of the internal ring

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 25, 2017
• Study Start: September 25, 2017
• Primary Completion: September 5, 2018
• Study Completion: September 6, 2018
• Last Updated: September 26, 2017

Record last verified: 2017-09