Inguinal HerniaNCT00940433
Hernia Repair Four Arm Comparative Study
A study testing open properitoneal hernia repair, Lechtestien hernia repair and Laparoscopic transperitoneal approach in people with Inguinal Hernia, run by University of Alexandria at 1 site in Egypt.
Trial summary
This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- open properitoneal hernia repair, Lechtestien hernia repair and Laparoscopic transperitoneal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2008to Dec 2009
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult male primary inguinal hernia
Who cannot join
- recurrent hernia previous lower abdominal surgery [excluding appendectomy]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs
This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.
Read the detailed description
The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.
- Conditions
- Inguinal Hernia
- Being tested
- open properitoneal hernia repair, Lechtestien hernia repair, Laparoscopic transperitoneal approach, Laparoscopic totally extraperitoneal approach
- Keywords
- Minimally invasive, Inguinal hernia, Pro-peritoneal repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open properitoneal hernia repairProcedure or surgery
Also called extraperitoneal repair
suprapubic retro-inguinal approach
Lechtestien hernia repairProcedure or surgery
Also called tension free repair
onlay mesh repair
Laparoscopic transperitoneal approachProcedure or surgery
Also called TAPP
intraperitoneal insufflation followed by re-exiting to the hernia site
Laparoscopic totally extraperitoneal approachProcedure or surgery
Also called TEP
avoiding the peritoneum altogether
| Study group | Role | What they receive |
|---|---|---|
| open properitoneal | Active comparator | patients undergoing open properitoneal hernia repair Receives: Procedure: open properitoneal hernia repair |
| Lechtenstien repair | Active comparator | Patients undergoing Lechtestien hernia repair Receives: Procedure: Lechtestien hernia repair |
| Laparoscopic transperitoneal repair | Active comparator | Patients undergoing TAPP repair Receives: Procedure: Laparoscopic transperitoneal approach |
| Lap totally extraperitoneal approach | Active comparator | Patients undergoing TEP approach Receives: Procedure: Laparoscopic totally extraperitoneal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient ability to resume domestic activity independently
Measured: daily reporting by the patient
Secondary outcomes (1)
time of the patient to return to work
Measured: reported by the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Investigators
- Yasser Hamza, A professor, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940433
- Sponsor's protocol ID
- # 90713
- Status last verified
- Jan 2010
- First submitted
- 15 Jul 2009
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs
- ClinicalTrials.gov ID
- NCT00940433
- Acronym / sponsor ID
- # 90713
- Conditions
- Inguinal Hernia
- Keywords
- Minimally invasive, Inguinal hernia, Pro-peritoneal repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jul 2009 (estimated)
- 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.
This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.
Detailed description
The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| open properitoneal | Active comparator | Procedure: open properitoneal hernia repairpatients undergoing open properitoneal hernia repair |
| Lechtenstien repair | Active comparator | Procedure: Lechtestien hernia repairPatients undergoing Lechtestien hernia repair |
| Laparoscopic transperitoneal repair | Active comparator | Procedure: Laparoscopic transperitoneal approachPatients undergoing TAPP repair |
| Lap totally extraperitoneal approach | Active comparator | Procedure: Laparoscopic totally extraperitoneal approachPatients undergoing TEP approach |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult male primary inguinal hernia
Key exclusion criteria (1 listed)
- recurrent hernia previous lower abdominal surgery [excluding appendectomy]
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 |
|---|---|---|
| open properitoneal hernia repairAlso: extraperitoneal repairsuprapubic retro-inguinal approach | Procedure or surgery | open properitoneal |
| Lechtestien hernia repairAlso: tension free repaironlay mesh repair | Procedure or surgery | Lechtenstien repair |
| Laparoscopic transperitoneal approachAlso: TAPPintraperitoneal insufflation followed by re-exiting to the hernia site | Procedure or surgery | Laparoscopic transperitoneal repair |
| Laparoscopic totally extraperitoneal approachAlso: TEPavoiding the peritoneum altogether | Procedure or surgery | Lap totally extraperitoneal approach |
Primary outcome
patient ability to resume domestic activity independently
Time frame: daily reporting by the patient
1 secondary outcome
time of the patient to return to work
Time frame: reported by the patient
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 15 Jan 2010.
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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.
Yasser Hamza, A professor principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open properitoneal hernia repair, Lechtestien hernia repair and Laparoscopic transperitoneal approach in people with Inguinal Hernia, run by University of Alexandria 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 15 Jan 2010. 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?
patient ability to resume domestic activity independently (time frame: daily reporting by the patient). 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 15 Jan 2010.