Inguinal HerniaNCT06514859
Repair of Inguinal Hernia
A study testing Laparoscopic repair of inguinal hernia and Open repair of inguinal hernia in people with Inguinal Hernia, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Laparoscopic repair of inguinal hernia and Open repair of inguinal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient > 18 years of age
- Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.
Who cannot join
- Emergency procedures .
- ASA score > 2.
- Irreducible inguinoscrotal hernia .
- Local or systemic infection .
- Other abdominal hernias being operated at the same time or planned operated during Follow up.
- Previous surgery which has impaired the sensation in the groin area .
Show all 10Show fewer
- BMI > 40 kg/m2.
- Known disease which Impairs central or peripheral nerve function .
- Concurrent malignant Disease .
- Chronic pain which requires daily medication . • Mental disorder which requires daily medication .
Trial locations and contacts
1 site in 1 country.
Alaa A Redwan, Prof contact
About this study
Official title: Outcomes of Laparoscopic Versus Open Repair of Inguinal Hernia
The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.
- Conditions
- Inguinal Hernia
- Being tested
- Laparoscopic repair of inguinal hernia, Open repair of inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic repair of inguinal herniaProcedure or surgery
Laparoscopic repair of inguinal hernia
Open repair of inguinal herniaProcedure or surgery
Repair of inguinal hernia by open technique-mesh hernioplasty -
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic repair of inguinal hernia | Active comparator | Not described Receives: Procedure: Laparoscopic repair of inguinal hernia |
| Open repair of inguinal hernia | Active comparator | Not described Receives: Procedure: Open repair of inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence in management of inguinal hernia
Rate of recurrence in both open and laparoscopic repair of inguinal hernia
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start10 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaziz Mohamed Abdelaziz, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514859
- Sponsor's protocol ID
- Soh-Med-24-06-07MS
- Status last verified
- Jun 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bhandarkar DS, Shankar M, Udwadia TE. Laparoscopic surgery for inguinal hernia: Current status and controversies. J Minim Access Surg. 2006 Sep;2(3):178-86. doi: 10.4103/0972-9941.27735.
PubMed 21187993Aguirre DA, Casola G, Sirlin C. Abdominal wall hernias: MDCT findings. AJR Am J Roentgenol. 2004 Sep;183(3):681-90. doi: 10.2214/ajr.183.3.1830681. No abstract available.
PubMed 15333356McCormack K, Wake B, Perez J, Fraser C, Cook J, McIntosh E, Vale L, Grant A. Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. Health Technol Assess. 2005 Apr;9(14):1-203, iii-iv. doi: 10.3310/hta9140.
PubMed 15842951
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Laparoscopic Versus Open Repair of Inguinal Hernia
- ClinicalTrials.gov ID
- NCT06514859
- Acronym / sponsor ID
- Soh-Med-24-06-07MS
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Jul 2024 (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.
The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic repair of inguinal hernia | Active comparator | Procedure: Laparoscopic repair of inguinal hernia |
| Open repair of inguinal hernia | Active comparator | Procedure: Open repair of inguinal hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patient > 18 years of age
- Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.
Key exclusion criteria (10 listed)
- Emergency procedures .
- Previous surgery which has impaired the sensation in the groin area .
- BMI > 40 kg/m2.
- Known disease which Impairs central or peripheral nerve function .
- Concurrent malignant Disease .
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 |
|---|---|---|
| Laparoscopic repair of inguinal herniaLaparoscopic repair of inguinal hernia | Procedure or surgery | Laparoscopic repair of inguinal hernia |
| Open repair of inguinal herniaRepair of inguinal hernia by open technique-mesh hernioplasty - | Procedure or surgery | Open repair of inguinal hernia |
Primary outcome
Recurrence in management of inguinal hernia
Time frame: 6 months after operation
Rate of recurrence in both open and laparoscopic repair of inguinal hernia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 21187993Bhandarkar DS, Shankar M, Udwadia TE. Laparoscopic surgery for inguinal hernia: Current status and controversies. J Minim Access Surg. 2006 Sep;2(3):178-86. doi: 10.4103/0972-9941.27735.
- Background: PubMed 15333356Aguirre DA, Casola G, Sirlin C. Abdominal wall hernias: MDCT findings. AJR Am J Roentgenol. 2004 Sep;183(3):681-90. doi: 10.2214/ajr.183.3.1830681. No abstract available.
- Background: PubMed 15842951McCormack K, Wake B, Perez J, Fraser C, Cook J, McIntosh E, Vale L, Grant A. Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. Health Technol Assess. 2005 Apr;9(14):1-203, iii-iv. doi: 10.3310/hta9140.
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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.
Alaa A Redwan, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic repair of inguinal hernia and Open repair of inguinal hernia in people with Inguinal Hernia, run by Sohag 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdul-aziz M Abdul-aziz (01026055970, adam1212asad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence in management of inguinal hernia (time frame: 6 months after operation). 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 NCT06514859, which also lists 3 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 23 Jul 2024.