- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04266561
Laparoscopic Recurrent Inguinal Hernia Repair
February 10, 2020 updated by: Rafik Shalaby, Al-Azhar University
Laparoscopic Management of Recurrent Inguinal Hernia in Children
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].
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- 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 Locations
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Cairo, Egypt, 11884
- Al-Housain University Hospital
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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
Ages Eligible for Study
6 months to 4 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recurrent inguinal hernia
Exclusion Criteria:
- complicated inguinal hernia
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: lap. recurent inguinal hernia repair
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: From the incision time to the closure of the wound
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The operative time is estimated by minutes.
The estimated operative time for unilateral and bilateral recurrent hernia are estimated
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From the incision time to the closure of the wound
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydrocele formation
Time Frame: one month postoperatively
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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
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one month postoperatively
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Testicular atrophy
Time Frame: three months postoperatively
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Clinical and ultrasound examination of the testis for estimation of testicular size in cm.
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three months postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rafik Shalaby, MD, Al-Azhar University, Nasr City, Cairo, Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Shalaby R, Desoky A. Needlescopic inguinal hernia repair in children. Pediatr Surg Int. 2002 Mar;18(2-3):153-6. doi: 10.1007/s003830100655.
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
February 1, 2010
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
June 24, 2014
First Submitted That Met QC Criteria
February 10, 2020
First Posted (ACTUAL)
February 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP-30121949
- Rafik-2015 (REGISTRY: Al-Azhar University)
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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