Inguinal HerniaNCT02723045
Quality of Life of TEP vs Lichtenstein Hernioplasty
A study testing Open Lichtenstein Hernioplasty and Laparoscopic TEP Hernioplasty in people with Inguinal Hernia, run by Sarawak General Hospital.
Trial summary
To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty 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?
- Open Lichtenstein Hernioplasty and Laparoscopic TEP Hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 2017
- 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
- 18 years of age and older
- Both genders
- Unilateral inguinal hernias
- Reducible inguinal hernias
- Elective setting
Who cannot join
- ASA Physical Status (American Society of Anaesthesiologists) Grade > 2
- Recurrence
- Inguinal-scrotal hernias
- Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
- Pregnancy
- Refusal for general anaesthesia
About this study
Official title: The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty
To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty
Read the detailed description
Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.
- Conditions
- Inguinal Hernia
- Being tested
- Open Lichtenstein Hernioplasty, Laparoscopic TEP Hernioplasty
- 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 Lichtenstein HernioplastyProcedure or surgery
Laparoscopic TEP HernioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Open modified Lichtenstein repair | Active comparator | Patients will undergo open repair of their inguinal hernias Receives: Procedure: Open Lichtenstein Hernioplasty |
| Laparoscopic TEP inguinal hernia repair | Active comparator | Patients will undergo laparoscopic repair of their inguinal hernias Receives: Procedure: Laparoscopic TEP Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Carolina Comfort Scale
Measured: 12 months
Secondary outcomes (4)
Operating time
Measured: 12 months
Duration of hospitalization
Measured: 12 months
Complications
Measured: 12 monthts
Recurrence
Recurrence of hernia after repair
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016 (estimated)
- Study completionSep 2017 (estimated)
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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarawak General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siow Sze Li, Sarawak General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723045
- Sponsor's protocol ID
- NMRR-16-277-29543
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty
- ClinicalTrials.gov ID
- NCT02723045
- Acronym / sponsor ID
- NMRR-16-277-29543
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sarawak General HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 Mar 2016 (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.
To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty
Detailed description
Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open modified Lichtenstein repair | Active comparator | Procedure: Open Lichtenstein HernioplastyPatients will undergo open repair of their inguinal hernias |
| Laparoscopic TEP inguinal hernia repair | Active comparator | Procedure: Laparoscopic TEP HernioplastyPatients will undergo laparoscopic repair of their inguinal hernias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Both genders
- Unilateral inguinal hernias
- Reducible inguinal hernias
- Elective setting
Key exclusion criteria (6 listed)
- ASA Physical Status (American Society of Anaesthesiologists) Grade > 2
- Recurrence
- Inguinal-scrotal hernias
- Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
- Pregnancy
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 Lichtenstein Hernioplasty | Procedure or surgery | Open modified Lichtenstein repair |
| Laparoscopic TEP Hernioplasty | Procedure or surgery | Laparoscopic TEP inguinal hernia repair |
Primary outcome
Quality of life
Time frame: 12 months
Carolina Comfort Scale
4 secondary outcomes
Operating time
Time frame: 12 months
Duration of hospitalization
Time frame: 12 months
Complications
Time frame: 12 monthts
Recurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Open Lichtenstein Hernioplasty and Laparoscopic TEP Hernioplasty in people with Inguinal Hernia, run by Sarawak General Hospital.
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 5 inclusion and 6 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Quality of life (time frame: 12 months). 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 30 Mar 2016.