Congenital HerniaNCT04266561
Laparoscopic Recurrent Inguinal Hernia Repair
A study testing hernia repair in people with Congenital Hernia, run by Al-Azhar University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Congenital Hernia
- What is being tested?
- hernia repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Recurrent inguinal hernia
Who cannot join
- complicated inguinal hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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].
Read the 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.
- Conditions
- Congenital Hernia
- Being tested
- hernia repair
- Keywords
- Laparoscopy, Recurrent inguinal hernia, Children
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernia repairOther
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.
| Study group | Role | What they receive |
|---|---|---|
| lap. recurent inguinal hernia repair | Other | 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 Receives: Other: hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The operative time is estimated by minutes. The estimated operative time for unilateral and bilateral recurrent hernia are estimated
Measured: From the incision time to the closure of the wound
Secondary outcomes (2)
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
Measured: one month postoperatively
Testicular atrophy
Clinical and ultrasound examination of the testis for estimation of testicular size in cm.
Measured: three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startFeb 2010
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafik Shalaby, Al-Azhar University
- Investigators
- Rafik Shalaby, MD, Principal investigator, Al-Azhar University, Nasr City, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266561
- Sponsor's protocol ID
- CTP-30121949
- Other IDs
- Rafik-2015
- Status last verified
- Feb 2020
- First submitted
- 24 Jun 2014
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21034946Shalaby 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.
PubMed 16567212Shalaby 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.
PubMed 23326656Shalaby R, Desoky A. Needlescopic inguinal hernia repair in children. Pediatr Surg Int. 2002 Mar;18(2-3):153-6. doi: 10.1007/s003830100655.
PubMed 11956783
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Management of Recurrent Inguinal Hernia in Children
- ClinicalTrials.gov ID
- NCT04266561
- Acronym / sponsor ID
- CTP-30121949
- Conditions
- Congenital Hernia
- Keywords
- Laparoscopy, Recurrent inguinal hernia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lap. recurent inguinal hernia repair | Other | Other: hernia repairAfter 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 |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Recurrent inguinal hernia
Key exclusion criteria (1 listed)
- complicated inguinal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hernia repairTwo 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. | Other | lap. recurent inguinal hernia repair |
Primary outcome
Operative time
Time frame: From the incision time to the closure of the wound
The operative time is estimated by minutes. The estimated operative time for unilateral and bilateral recurrent hernia are estimated
2 secondary outcomes
Hydrocele formation
Time frame: one month postoperatively
Testicular atrophy
Time frame: three months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 21034946Shalaby 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.
- Background: PubMed 16567212Shalaby 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.
- Background: PubMed 23326656Shalaby 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.
- Background: PubMed 11956783Shalaby R, Desoky A. Needlescopic inguinal hernia repair in children. Pediatr Surg Int. 2002 Mar;18(2-3):153-6. doi: 10.1007/s003830100655.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafik Shalaby, MD principal investigator
Al-Azhar University, Nasr City, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hernia repair in people with Congenital Hernia, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: From the incision time to the closure of the wound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266561, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.