Inguinal Hernia RepairNCT06712212
Non-mesh Repair of Inguinal Hernia: Desarda Versus Darn
A study testing Inguinal Hernias repair: Desarda and Inguinal hernia repair: Darn in people with Inguinal Hernia Repair and Inguinal Hernia, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the results of Desarda and Darn techniques in inguinal hernia repair in Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia Repair, Inguinal Hernia
- What is being tested?
- Inguinal Hernias repair: Desarda and Inguinal hernia repair: Darn
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inguinal hernia
- Age more than 18
- Male patients
Who cannot join
- simultaneous performance of other surgical procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To compare the results of Desarda and Darn techniques in inguinal hernia repair in Assiut University Hospital.
Read the detailed description
Inguinal hernia is one of the most common types of abdominal hernias with a prevalence of 75% of all abdominal hernias. Inguinal hernia repair is one of the most encountered surgeries all over the world. The use of mesh for inguinal hernia repair is the most commonly applied technique. However, being a foreign body, mesh repair has its own disadvantages. These include Postoperative hematoma and seroma, foreign body reaction, infection, mesh rejection, mesh migration, and fistula formation. Moreover, the use of mesh in potentially contaminated operating field is not advisable. Infectious complication and their consequences have restricted the use of mesh in emergency settings. In addition, mesh repair is not available in every part of the world since it increases the cost of the operation. Therefore, the non-mesh repair of inguinal hernia has been recently revisited. Different techniques for non-mesh inguinal hernia repair are available including Bassini, Shouldice, Desarda and Darn. In 2001,Indian Surgeon Dr. Desarda, introduced a novel technique of a tissue- based hernia repair without mesh with almost zero recurrence rates in which an undetached strip of the external oblique aponeurosis is sutured to the inguinal ligament below and the muscle arch above, behind the cord, to form a new posterior wall. External oblique muscle gives additional strength to the weakened muscle arch to keep this strip physiologically dynamic. In 1948, Moloney described a suture inguinal herniorrhaphy in which two layers of continuous monofilament non-absorbable suture lines with no tension were inserted. The first suture line is between the lower edge of the internal oblique muscle/aponeurosis and the inguinal ligament. The second superficial layer is between the rectus sheath and the inguinal ligament. All sutures should be placed without tension but with no slack .
Literature are deficient in comparing Desarda technique and Darn technique in the repair of inguinal hernia.
- Conditions
- Inguinal Hernia Repair, Inguinal Hernia
- Being tested
- Inguinal Hernias repair: Desarda, Inguinal hernia repair: Darn
- Keywords
- Hernia, Desarda repair, Darn repair, Inguinal Hernia
- 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.
Inguinal Hernias repair: DesardaProcedure or surgery
Also called Desarda repair of inguinal hernia
A splitting incision is made in this sutured medial leaf, partially separating a strip 1.5-2 cm wide. This splitting incision is extended medially up to the pubic symphysis and 1-2 cm beyond the abdominal ring laterally. The medial insertion and lateral continuation of this strip is kept intact. The upper free border of the strip is now sutured to the internal oblique with number 1 Monofilament Polydioxanone Violet continuous sutures all along its length. This will result in the strip of the EOA being placed behind the cord to form a new posterior wall of the inguinal canal. The spermatic cord is placed in the inguinal canal and the lateral leaf of the EOA is sutured to the newly formed medial leaf of the EOA in front of the cord. As before, number 1 Monofilament Polydioxanone Violet continuous sutures were used. Undermining of the newly formed medial leaf on both its surfaces and excision of the bulky cremasteric muscle facilitate its approximation to the lateral leaf
Inguinal hernia repair: DarnProcedure or surgery
Also called Darn repair of inguinal hernia
Skin and fascia are incised using a regular, oblique inguinal incision to expose the external oblique aponeurosis (EOA) the inguinal canal is opened into by dividing the external oblique aponeurosis through the external ring. After dealing with the hernia sac, a 0-size monofilament suture was used to reconstruct the inguinal bed with a tension-free darn starting with a good strong bite of the tough tendinous structures near the pubic tubercle and emerging out through the lateral edge of the internal oblique/rectus sheath from one side and through the inguinal ligament on the other side. The loosely interwoven bites continued laterally and the back-forming two rows of continuous stitches were placed in a staggered manner to spread the tension between the fibres of the inguinal ligament. Afterwards, the external oblique and other superficial layers with the skin are classically closed
| Study group | Role | What they receive |
|---|---|---|
| Inguinal hernia | Active comparator | Not described Receives: Procedure: Inguinal Hernias repair: Desarda; Procedure: Inguinal hernia repair: Darn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term recurrence of hernia
Measured: From the day post operative to 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Hamad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712212
- Sponsor's protocol ID
- Inguinal hernia repair
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-mesh Repair of Inguinal Hernia: Desarda Versus Darn
- ClinicalTrials.gov ID
- NCT06712212
- Acronym / sponsor ID
- Inguinal hernia repair
- Conditions
- Inguinal Hernia Repair, Inguinal Hernia
- Keywords
- Hernia, Desarda repair, Darn repair, Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
To compare the results of Desarda and Darn techniques in inguinal hernia repair in Assiut University Hospital.
Detailed description
Inguinal hernia is one of the most common types of abdominal hernias with a prevalence of 75% of all abdominal hernias. Inguinal hernia repair is one of the most encountered surgeries all over the world. The use of mesh for inguinal hernia repair is the most commonly applied technique. However, being a foreign body, mesh repair has its own disadvantages. These include Postoperative hematoma and seroma, foreign body reaction, infection, mesh rejection, mesh migration, and fistula formation. Moreover, the use of mesh in potentially contaminated operating field is not advisable. Infectious complication and their consequences have restricted the use of mesh in emergency settings. In addition, mesh repair is not available in every part of the world since it increases the cost of the operation. Therefore, the non-mesh repair of inguinal hernia has been recently revisited. Different techniques for non-mesh inguinal hernia repair are available including Bassini, Shouldice, Desarda and Darn. In 2001,Indian Surgeon Dr. Desarda, introduced a novel technique of a tissue- based hernia repair without mesh with almost zero recurrence rates in which an undetached strip of the external oblique aponeurosis is sutured to the inguinal ligament below and the muscle arch above, behind the cord, to form a new posterior wall. External oblique muscle gives additional strength to the weakened muscle arch to keep this strip physiologically dynamic. In 1948, Moloney described a suture inguinal herniorrhaphy in which two layers of continuous monofilament non-absorbable suture lines with no tension were inserted. The first suture line is between the lower edge of the internal oblique muscle/aponeurosis and the inguinal ligament. The second superficial layer is between the rectus sheath and the inguinal ligament. All sutures should be placed without tension but with no slack .
Literature are deficient in comparing Desarda technique and Darn technique in the repair of inguinal hernia.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inguinal hernia | Active comparator | Procedure: Inguinal Hernias repair: Desarda, Procedure: Inguinal hernia repair: Darn |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- inguinal hernia
- Age more than 18
- Male patients
Key exclusion criteria (1 listed)
- simultaneous performance of other surgical procedures
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 |
|---|---|---|
| Inguinal Hernias repair: DesardaAlso: Desarda repair of inguinal herniaA splitting incision is made in this sutured medial leaf, partially separating a strip 1.5-2 cm wide. This splitting incision is extended medially up to the pubic symphysis and 1-2 cm beyond the abdominal ring laterally. The medial insertion and lateral continuation of this strip is kept intact. The upper free border of the strip is now sutured to the internal oblique with number 1 Monofilament Polydioxanone Violet continuous sutures all along its length. This will result in the strip of the EOA being placed behind the cord to form a new posterior wall of the inguinal canal. The spermatic cord is placed in the inguinal canal and the lateral leaf of the EOA is sutured to the newly formed medial leaf of the EOA in front of the cord. As before, number 1 Monofilament Polydioxanone Violet continuous sutures were used. Undermining of the newly formed medial leaf on both its surfaces and excision of the bulky cremasteric muscle facilitate its approximation to the lateral leaf | Procedure or surgery | Inguinal hernia |
| Inguinal hernia repair: DarnAlso: Darn repair of inguinal herniaSkin and fascia are incised using a regular, oblique inguinal incision to expose the external oblique aponeurosis (EOA) the inguinal canal is opened into by dividing the external oblique aponeurosis through the external ring. After dealing with the hernia sac, a 0-size monofilament suture was used to reconstruct the inguinal bed with a tension-free darn starting with a good strong bite of the tough tendinous structures near the pubic tubercle and emerging out through the lateral edge of the internal oblique/rectus sheath from one side and through the inguinal ligament on the other side. The loosely interwoven bites continued laterally and the back-forming two rows of continuous stitches were placed in a staggered manner to spread the tension between the fibres of the inguinal ligament. Afterwards, the external oblique and other superficial layers with the skin are classically closed | Procedure or surgery | Inguinal hernia |
Primary outcome
Short term recurrence of hernia
Time frame: From the day post operative to 6 months after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inguinal Hernias repair: Desarda and Inguinal hernia repair: Darn in people with Inguinal Hernia Repair and Inguinal Hernia, run by Assiut University 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 3 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: enrolling by invitation, as of the sponsor's last update on 2 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Short term recurrence of hernia (time frame: From the day post operative to 6 months after the operation). 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 2 Dec 2024.