Postoperative PainNCT04850131
Desarda Repair Compared to Lichtenstein Repair for the Treatment of Inguinal Hernias
A study testing Desarda repair in people with Postoperative Pain and Recurrence, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
Trial summary
The Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide mobile and the physiologically dynamic posterior wall. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Recurrence, Wound Complication
- What is being tested?
- Desarda repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2019to 30 Mar 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of age between 20 to 70years
- A primary inguinal hernia
- Consented to participate in the research.
Who cannot join
- Age below 20,
- Recurrent and pantaloons hernia
- Patients who did not give the informed consent
- Patients who lose the follow-up
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Benazir Bhutto Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000
About this study
Official title: Mesh Free Desarda Repair Compared With Lichtenstein Repair for the Treatment of Primary Inguinal Hernias
The Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide mobile and the physiologically dynamic posterior wall. The most dangerous complication associated with the mesh prosthesis is its migration from the abdominal cavity's primary implantation site. The relatively knew technique developed by Dr. Desarda does not utilize the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the posterior wall. Our study has compared the two methods regarding various aspects.
- Conditions
- Postoperative Pain, Recurrence, Wound Complication
- Being tested
- Desarda repair
- Keywords
- Desarda Repair, Comparison, Lichtenstein Repair, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desarda repairProcedure or surgery
Also called Lichtenstein repair
Desarda is a new tissue-based technique developed from applying the externally oblique muscle aponeurosis in the form of an undetached strip making the posterior wall in the inguinal canal stiffer. This paper focuses on analyzing comparisons between mesh-free Desarda repair and the Lichtenstein technique for the treatment of hernia inguinalis
| Study group | Role | What they receive |
|---|---|---|
| Desarda | Active comparator | Forty-one patients who were randomly assigned to the Desarda group underwent the Desarda repair for their problem. Patients were followed for various data point values during operation, immediately after the operation, and for a period of one year post-operatively. Receives: Procedure: Desarda repair |
| Lichtenstein | Active comparator | Forty-one patients randomly assigned to the Lichtenstein group underwent the standard mesh repair and were followed for the same data point values and variables for the same specified period of time. Receives: Procedure: Desarda repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain
Measured: 24 hours after the surgery
Postoperative pain
Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain
Measured: 3 months after the primary surgery
Recurrence
Described as reappearance of the inguinal hernia on the operated side
Measured: Within 01 year of the primary surgery
Secondary outcomes (1)
Wound complication
Described as number of patients developing the wound complications like seroma , hematoma formation and surgical site infection.
Measured: Complications occuring within 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 May 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Model description
- A total of 82 patients with inguinal hernias were selected randomly to participate in this study. They were subjected to either Lichtenstein hernioplasty or Desarda herniorrhaphy. A follow-up was conducted to analyze the hospital stay, return to work, recurrence rate, chronic pain, postoperative complications, and cost-effectiveness.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benazir Bhutto Hospital, Rawalpindi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Usman Ghani, Benazir Bhutto Hospital, Rawalpindi
- Investigators
- MUHAMMAD USMAN GHANI, FCPS, Principal investigator, BENAZIR BHUTTO HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850131
- Sponsor's protocol ID
- 274/IREF\RMU\2020
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Free Desarda Repair Compared With Lichtenstein Repair for the Treatment of Primary Inguinal Hernias
- ClinicalTrials.gov ID
- NCT04850131
- Acronym / sponsor ID
- 274/IREF\RMU\2020
- Conditions
- Postoperative Pain, Recurrence, Wound Complication
- Keywords
- Desarda Repair, Comparison, Lichtenstein Repair, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Benazir Bhutto Hospital, RawalpindiOther government
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 20 Apr 2021 (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 Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide mobile and the physiologically dynamic posterior wall. The most dangerous complication associated with the mesh prosthesis is its migration from the abdominal cavity's primary implantation site. The relatively knew technique developed by Dr. Desarda does not utilize the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the posterior wall. Our study has compared the two methods regarding various aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 82 patients with inguinal hernias were selected randomly to participate in this study. They were subjected to either Lichtenstein hernioplasty or Desarda herniorrhaphy. A follow-up was conducted to analyze the hospital stay, return to work, recurrence rate, chronic pain, postoperative complications, and cost-effectiveness.
| Arm | Type | Receives |
|---|---|---|
| Desarda | Active comparator | Procedure: Desarda repairForty-one patients who were randomly assigned to the Desarda group underwent the Desarda repair for their problem. Patients were followed for various data point values during operation, immediately after the operation, and for a period of one year post-operatively. |
| Lichtenstein | Active comparator | Procedure: Desarda repairForty-one patients randomly assigned to the Lichtenstein group underwent the standard mesh repair and were followed for the same data point values and variables for the same specified period of time. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age between 20 to 70years
- A primary inguinal hernia
- Consented to participate in the research.
Key exclusion criteria (4 listed)
- Age below 20,
- Recurrent and pantaloons hernia
- Patients who did not give the informed consent
- Patients who lose the follow-up
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 |
|---|---|---|
| Desarda repairAlso: Lichtenstein repairDesarda is a new tissue-based technique developed from applying the externally oblique muscle aponeurosis in the form of an undetached strip making the posterior wall in the inguinal canal stiffer. This paper focuses on analyzing comparisons between mesh-free Desarda repair and the Lichtenstein technique for the treatment of hernia inguinalis | Procedure or surgery | Desarda, Lichtenstein |
Primary outcome
Postoperative pain
Time frame: 24 hours after the surgery
Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain
Postoperative pain
Time frame: 3 months after the primary surgery
Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain
Recurrence
Time frame: Within 01 year of the primary surgery
Described as reappearance of the inguinal hernia on the operated side
1 secondary outcome
Wound complication
Time frame: Complications occuring within 30 days after the surgery
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 20 Apr 2021.
- 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.
MUHAMMAD USMAN GHANI, FCPS principal investigator
BENAZIR BHUTTO HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desarda repair in people with Postoperative Pain and Recurrence, run by Benazir Bhutto Hospital, Rawalpindi 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 3 inclusion and 4 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 20 Apr 2021. 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?
Postoperative pain (time frame: 24 hours after the surgery). The study lists 3 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 Apr 2021.