Inguinal HerniaNCT05011786
Open and Laparoscopic Hernia Repair. A Comparative Study
An observational study of Inguinal Hernia, run by Ibrahim Khrais at 1 site in Jordan.
Trial summary
A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population. Read more about this study
- Who is it for?
- Ages 6 months to 13 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- hernia repair/ligation of the hernial sac
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2017to 30 Dec 2020
- Phase
- Observational
- 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 13 years
- All sexes
- Child
Study population: all children aged between 6 months and 13 years who underwent open or laparoscopic inguinal hernia repair at the Jordan University Hospital in the period between January 2017 and July 2019
Who may be able to join
- All children within the age limit specified were included in the study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Open Approach Superior to the Laparoscopic Hernia Repair in Children? A Retrospective Comparative Study.
A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.
Read the detailed description
The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.
- Conditions
- Inguinal Hernia
- Being tested
- hernia repair/ligation of the hernial sac
- 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 repair/ligation of the hernial sacProcedure or surgery
the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group
| Study group | Role | What they receive |
|---|---|---|
| Open repair group | children with inguinal hernia who were repaired with open high ligation of the hernia sac through an inguinal incision. Receives: Procedure: hernia repair/ligation of the hernial sac | |
| Laparoscopic repair group | children with inguinal hernia who were repaired laparoscopically by closing the the PPV at the level of internal ring with a purse string suture Receives: Procedure: hernia repair/ligation of the hernial sac |
What is being measured
The primary outcome is the main question the study is designed to answer.
OR duration
Measured: During surgery
Length of stay LOS
Measured: 1 year
Post operative complications
Measured: 1 year
Hernia Recurrence
Measured: 1 year
Total Cost of Surgery
Measured: 1 year
Cosmesis
What does the parents of the children think of the cosmetic outcomes of the surgery on a scale from 1-5
Measured: 1 Year
Recovery
Time from discharge to resuming normal daily activities
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Jan 2017
- Primary completion30 Jul 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibrahim Khrais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ibrahim Khrais, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011786
- Sponsor's protocol ID
- 67-2019-5771
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Open Approach Superior to the Laparoscopic Hernia Repair in Children? A Retrospective Comparative Study.
- ClinicalTrials.gov ID
- NCT05011786
- Acronym / sponsor ID
- 67-2019-5771
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Ibrahim KhraisUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 18 Aug 2021 (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.
A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.
Detailed description
The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open repair group | – | Procedure: hernia repair/ligation of the hernial sacchildren with inguinal hernia who were repaired with open high ligation of the hernia sac through an inguinal incision. |
| Laparoscopic repair group | – | Procedure: hernia repair/ligation of the hernial sacchildren with inguinal hernia who were repaired laparoscopically by closing the the PPV at the level of internal ring with a purse string suture |
Who may qualify
- Ages
- 6 months to 13 years
- Sex
- All
- Age groups
- Child
- Study population
- all children aged between 6 months and 13 years who underwent open or laparoscopic inguinal hernia repair at the Jordan University Hospital in the period between January 2017 and July 2019
Key inclusion criteria (1 listed)
- All children within the age limit specified were included in the study
Key exclusion criteria (1 listed)
- none
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 repair/ligation of the hernial sacthe inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group | Procedure or surgery | Laparoscopic repair group, Open repair group |
Primary outcome
OR duration
Time frame: During surgery
Length of stay LOS
Time frame: 1 year
Post operative complications
Time frame: 1 year
Hernia Recurrence
Time frame: 1 year
Total Cost of Surgery
Time frame: 1 year
Cosmesis
Time frame: 1 Year
What does the parents of the children think of the cosmetic outcomes of the surgery on a scale from 1-5
Recovery
Time frame: year
Time from discharge to resuming normal daily activities
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 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Ibrahim Khrais at 1 site in Jordan.
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 18 Aug 2021. 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 Jordan. 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?
OR duration (time frame: During surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2021.