Hernia, InguinalIHRNCT00941941
Non-Mesh Versus Mesh Method for Inguinal Hernia Repair
A study testing Non-mesh Hernia Repair and Mesh Hernia Repair in people with Hernia, Inguinal, run by Makerere University at 1 site in Uganda.
Trial summary
The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Non-mesh Hernia Repair and Mesh Hernia Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUganda
- Study dates
- May 2009to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and above;
- with a primary, reducible inguinal or inguino-scrotal hernia;
- who consent to participate in the study;
- who have a telephone contact.
Who cannot join
- Giant inguino-scrotal hernias;
- Obstructive uropathy or chronic obstructive pulmonary disease;
- Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial
The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.
The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.
- Conditions
- Hernia, Inguinal
- Being tested
- Non-mesh Hernia Repair, Mesh Hernia Repair
- Keywords
- Inguinal, Hernia, Hernia-repair, Non-mesh, Mesh, Desarda, Lichtenstein
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-mesh Hernia RepairProcedure or surgery
Also called Desarda repair
Non-mesh method for treatment of inguinal hernia without the use of a foreign material (mesh). It involves reinforcement of the weakened posterior wall of inguinal canal with a small, undetached strip of aponeurotic tissue of external
Mesh Hernia RepairProcedure or surgery
Also called Lichtenstein repair
Mesh method for treatment of inguinal hernias by use of an implant (mesh) to reinforce the weakened posterior wall of the inguinal canal. The mesh is made of polypropylene material.
| Study group | Role | What they receive |
|---|---|---|
| Non-mesh Hernia Repair | Experimental | Reinforcement with a strip of external oblique aponeurosis Receives: Procedure: Non-mesh Hernia Repair |
| Mesh Hernia Repair | Active comparator | Polypropylene mesh placement Receives: Procedure: Mesh Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)
Measured: 2 Weeks
Time (in days) taken to return to normal gait
Measured: 2 Weeks
Secondary outcomes (2)
Operative time (in Minutes)
Measured: 2 hours
Complications during and after surgery
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Mulago Hospital, Uganda
- Investigators
- William Manyilirah, Principal investigator, Makerere UniversityAlex Upoki, Study chair, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941941
- Sponsor's protocol ID
- 2006/HD11/6219U
- Other IDs
- REC REF 2009-080
- Acronym
- IHR
- Status last verified
- Jul 2009
- First submitted
- 11 Jul 2009
- Last updated
- 20 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00941941
- Acronym / sponsor ID
- IHR / 2006/HD11/6219U
- Conditions
- Hernia, Inguinal
- Keywords
- Inguinal, Hernia, Hernia-repair, Non-mesh, Mesh, Desarda, Lichtenstein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Mulago Hospital, Uganda
- Study start
- May 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 20 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.
The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.
The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-mesh Hernia Repair | Experimental | Procedure: Non-mesh Hernia RepairReinforcement with a strip of external oblique aponeurosis |
| Mesh Hernia Repair | Active comparator | Procedure: Mesh Hernia RepairPolypropylene mesh placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 and above;
- with a primary, reducible inguinal or inguino-scrotal hernia;
- who consent to participate in the study;
- who have a telephone contact.
Key exclusion criteria (3 listed)
- Giant inguino-scrotal hernias;
- Obstructive uropathy or chronic obstructive pulmonary disease;
- Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.
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 |
|---|---|---|
| Non-mesh Hernia RepairAlso: Desarda repairNon-mesh method for treatment of inguinal hernia without the use of a foreign material (mesh). It involves reinforcement of the weakened posterior wall of inguinal canal with a small, undetached strip of aponeurotic tissue of external | Procedure or surgery | Non-mesh Hernia Repair |
| Mesh Hernia RepairAlso: Lichtenstein repairMesh method for treatment of inguinal hernias by use of an implant (mesh) to reinforce the weakened posterior wall of the inguinal canal. The mesh is made of polypropylene material. | Procedure or surgery | Mesh Hernia Repair |
Primary outcome
Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)
Time frame: 2 Weeks
Time (in days) taken to return to normal gait
Time frame: 2 Weeks
2 secondary outcomes
Operative time (in Minutes)
Time frame: 2 hours
Complications during and after surgery
Time frame: 2 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2009.
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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.
William Manyilirah principal investigator
Makerere University
Alex Upoki study chair
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-mesh Hernia Repair and Mesh Hernia Repair in people with Hernia, Inguinal, run by Makerere University at 1 site in Uganda.
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 4 inclusion and 3 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 20 Jul 2009. 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 Uganda. 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?
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?
Acute groin pain after surgery (measured on pain visual analogue scale of 0-10) (time frame: 2 Weeks). The study lists 2 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 20 Jul 2009.