Paraumbilical HerniaNCT03766061
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
A study testing Onlay mesh Hernioplasty and Sublay Mesh Hernioplasty in people with Paraumbilical Hernia, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Paraumbilical Hernia
- What is being tested?
- Onlay mesh Hernioplasty and Sublay Mesh Hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2017to 1 Jul 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter
Who cannot join
- defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.
- Conditions
- Paraumbilical Hernia
- Being tested
- Onlay mesh Hernioplasty, Sublay Mesh Hernioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay mesh HernioplastyProcedure or surgery
Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath
Sublay Mesh HernioplastyProcedure or surgery
Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space
| Study group | Role | What they receive |
|---|---|---|
| Onlay Mesh Hernioplasty | Active comparator | In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath Receives: Procedure: Onlay mesh Hernioplasty |
| Sublay Mesh Hernioplasty | Active comparator | In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space Receives: Procedure: Sublay Mesh Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients presenting with recurrence of hernia
Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery
Measured: 8 months
Secondary outcomes (2)
Postoperative pain from score 1 to 10
Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum
Measured: 3 days
Hospital Stay duration in days
hospital stay (duration of patient from surgery to discharge) after surgery
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraumbilical 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 (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766061
- Sponsor's protocol ID
- s8
- Status last verified
- Jan 2019
- First submitted
- 13 Jul 2018
- Last updated
- 1 Feb 2019
- Results posted
- 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
- ClinicalTrials.gov ID
- NCT03766061
- Acronym / sponsor ID
- s8
- Conditions
- Paraumbilical Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 5 Dec 2018 (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.
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onlay Mesh Hernioplasty | Active comparator | Procedure: Onlay mesh HernioplastyIn this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath |
| Sublay Mesh Hernioplasty | Active comparator | Procedure: Sublay Mesh HernioplastyIn this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter
Key exclusion criteria (1 listed)
- defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes
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 |
|---|---|---|
| Onlay mesh HernioplastyPatients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath | Procedure or surgery | Onlay Mesh Hernioplasty |
| Sublay Mesh HernioplastyPatients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space | Procedure or surgery | Sublay Mesh Hernioplasty |
Primary outcome
Percentage of patients presenting with recurrence of hernia
Time frame: 8 months
Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery
2 secondary outcomes
Postoperative pain from score 1 to 10
Time frame: 3 days
Hospital Stay duration in days
Time frame: 1 week
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 1 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Paraumbilical Hernia
Recruiting
Comparison of Extended Totally Extra-peritoneal Repair (ETEP) and Subcutaneous On-lay Endoscopic Approach (SCOLA) for Para-umbilical Hernia (PUH).
Paraumbilical Hernia
Not yet recruitingObservational study
Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair
Abdominal Disorder
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.
Mahmmood Ayyaz, mbbs, fcps study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onlay mesh Hernioplasty and Sublay Mesh Hernioplasty in people with Paraumbilical Hernia, run by Services Hospital, Lahore at 1 site in Pakistan.
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 1 Feb 2019. 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 Pakistan. 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?
Percentage of patients presenting with recurrence of hernia (time frame: 8 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 1 Feb 2019.