Laparoscopic Recurrent Inguinal Hernia Repair
Primary Purpose
Congenital Hernia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Hernia focused on measuring Laparoscopy, Recurrent inguinal hernia, Children
Eligibility Criteria
Inclusion Criteria:
- Recurrent inguinal hernia
Exclusion Criteria:
- complicated inguinal hernia
Sites / Locations
- Al-Housain University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
lap. recurent inguinal hernia repair
Arm Description
After induction of general anesthesia, the patient was placed supine in Trendelenburg's position. Insertion of the main umbilical port. Laparoscopic hernia repair was done by intracorporeal insertion of purse string technique with some modifications
Outcomes
Primary Outcome Measures
Operative time
The operative time is estimated by minutes. The estimated operative time for unilateral and bilateral recurrent hernia are estimated
Secondary Outcome Measures
Hydrocele formation
Clinical and ultrasound examination of the scrotum. Hydrocele is diagnosed by the presence of fluids in the tunica albugenia around the testis. It is measured by ml liter
Testicular atrophy
Clinical and ultrasound examination of the testis for estimation of testicular size in cm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04266561
Brief Title
Laparoscopic Recurrent Inguinal Hernia Repair
Official Title
Laparoscopic Management of Recurrent Inguinal Hernia in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoscopic management of recurrent inguinal hernia in children has been recently introduced in surgical practice. One of the most important advantages of using the laparoscopic approach in cases with recurrent inguinal hernia (RIH) is that it avoids the previous operation site thus avoiding injuries to the vas and vessels [19]. Some authors designed a study to compare laparoscopic hernia repairs with classical open repairs for pediatric RIH following the first open repair. They stated that avoiding the scarred tissue the former operation area with the laparoscopic approach facilitates the procedure and decreases both the operative time and complication rate. [5]. Further, it is as simple as a fresh hernia repair because the time taken for the repair of recurrent hernia laparoscopically was the same as the fresh laparoscopic repair with no added complication [5,20]. In laparoscopic surgery, approaching the hernia defect from within the abdomen, makes the area of interest bloodless, and the magnification renders anatomy very clear, making surgery precise [6,7].
Detailed Description
Abstract: Background: Open repair of recurrent inguinal hernias [RIH] in infancy and childhood is difficult and there is definite risk of damaging the vas deferens and testicular vessels. Laparoscopic repair of RIH has the benefit of avoiding the previous operative site. The aim of this study is to present the investigator's experience with laparoscopic repair of RIH either after open or laparoscopic hernia repair with stress on technical refinements to prevent recurrence. Patients and methods: This is a retrospective study of laparoscopic repair of recurrent inguinal hernia. Records of patients that have been subjected to laparoscopic inguinal hernia repair for RIH were reviewed and evaluated. All patients were subjected to laparoscopic repair of 42 recurrent hernial defects. The primary outcome measurements of this study include; operative time. The secondary outcomes include; hydrocele formation, iatrogenic ascent of the testis and testicular atrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hernia
Keywords
Laparoscopy, Recurrent inguinal hernia, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lap. recurent inguinal hernia repair
Arm Type
Other
Arm Description
After induction of general anesthesia, the patient was placed supine in Trendelenburg's position. Insertion of the main umbilical port. Laparoscopic hernia repair was done by intracorporeal insertion of purse string technique with some modifications
Intervention Type
Other
Intervention Name(s)
hernia repair
Intervention Description
Two 3-mm needle holders were used for stitching the wide IIR. Then the suture was continued along the upper margin of IIR, but in a deeper plane to include the peritoneum and the deeper fascia transversalis.
Primary Outcome Measure Information:
Title
Operative time
Description
The operative time is estimated by minutes. The estimated operative time for unilateral and bilateral recurrent hernia are estimated
Time Frame
From the incision time to the closure of the wound
Secondary Outcome Measure Information:
Title
Hydrocele formation
Description
Clinical and ultrasound examination of the scrotum. Hydrocele is diagnosed by the presence of fluids in the tunica albugenia around the testis. It is measured by ml liter
Time Frame
one month postoperatively
Title
Testicular atrophy
Description
Clinical and ultrasound examination of the testis for estimation of testicular size in cm.
Time Frame
three months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent inguinal hernia
Exclusion Criteria:
complicated inguinal hernia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafik Shalaby, MD
Organizational Affiliation
Al-Azhar University, Nasr City, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Housain University Hospital
City
Cairo
ZIP/Postal Code
11884
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
21034946
Citation
Shalaby R, Ismail M, Dorgham A, Hefny K, Alsaied G, Gabr K, Abdelaziz M. Laparoscopic hernia repair in infancy and childhood: evaluation of 2 different techniques. J Pediatr Surg. 2010 Nov;45(11):2210-6. doi: 10.1016/j.jpedsurg.2010.07.004.
Results Reference
background
PubMed Identifier
16567212
Citation
Shalaby RY, Fawy M, Soliman SM, Dorgham A. A new simplified technique for needlescopic inguinal herniorrhaphy in children. J Pediatr Surg. 2006 Apr;41(4):863-7. doi: 10.1016/j.jpedsurg.2005.12.042.
Results Reference
background
PubMed Identifier
23326656
Citation
Shalaby R, Ibrahem R, Shahin M, Yehya A, Abdalrazek M, Alsayaad I, Shouker MA. Laparoscopic Hernia Repair versus Open Herniotomy in Children: A Controlled Randomized Study. Minim Invasive Surg. 2012;2012:484135. doi: 10.1155/2012/484135. Epub 2012 Dec 27.
Results Reference
background
PubMed Identifier
11956783
Citation
Shalaby R, Desoky A. Needlescopic inguinal hernia repair in children. Pediatr Surg Int. 2002 Mar;18(2-3):153-6. doi: 10.1007/s003830100655.
Results Reference
background
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Laparoscopic Recurrent Inguinal Hernia Repair
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