Hernias Inguinal ReducibleNCT03512366
Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia
A study testing Desarda's technique and Lichtenstein's technique in people with Hernias Inguinal Reducible and Local Anaesthesia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hernias Inguinal Reducible, Local Anaesthesia
- What is being tested?
- Desarda's technique and Lichtenstein's technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- 9 Dec 2017to Nov 2020
- 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 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary uncomplicated inguinal hernia
- Male patients aged more than 18 years and less than 80 years
- BMI less than 30kg/sq m
- American Society of Anaesthesiologists (ASA) scale less than III
Who cannot join
- Patients with recurrent, irreducible or strangulated inguinal hernias
- Patients unable to interpret VAS or give consent
- Patients participating in other clinical trials
- Patients with infection in the inguinal region or epididymo-orchitis
- Patients allergic to local anaesthetics
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
About this study
Official title: Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial
Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of hernia repair under local anaesthesia in terms of feasibility, economic benefits, faster ambulation with less complications. The purpose of the study is to find a method that will lead to faster disposal of patients and early return to activities, thereby reducing the waiting list of patients that compromises their financial and social spheres and overwhelms the welfare system.
Read the detailed description
Inguinal hernia is one of the most common treatable surgical conditions. The synthetic prostheses most often used in the inguinal area may in some cases create new clinical problems, such as foreign body sensation in the groin, discomfort, and abdominal wall stiffness, surgical site infections, migration of mesh and may affect procreation and sexual function, The cost and availability of mesh prostheses in smaller towns and underdeveloped regions proves to be a major hindrance. The requirement of the hour is to find a technique that is simple, cost effective, easy to perform, does not require extensive dissection or use of a foreign body, and also gives an acceptable recurrence rate without any major intra or post-operative complications and can be performed as a day care procedure to reduce the burden of cases in our community. A possible option for this is the Desarda method, presented in 2001, which uses an undetached strip of aponeurosis of the external oblique muscle instead of a mesh and has shown to have promising results in studies conducted so far. Several retrospective and randomized controlled trials have shown that local anaesthesia provides the best clinical and economic benefits to patients undergoing inguinal hernia repair. As there have been no studies till date comparing the outcomes for patients operated by these methods under local anaesthesia only, hence this study has been planned to assess if Desarda's technique is suitable to be used as a day care procedure with early return to normal activities after surgery, less post operative discomfort and minimum dose of analgesics and acceptable recurrence rates. This will help reduce the burden of the hospitals as these patients can be operated on a day care basis with minimal discomfort.
- Conditions
- Hernias Inguinal Reducible, Local Anaesthesia
- Being tested
- Desarda's technique, Lichtenstein's technique
- Keywords
- inguinal hernia, lichtenstein's technique, desarda's technique, local anaesthesia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desarda's techniqueProcedure or surgery
Also called Desarda's No mesh repair
It will be performed by separating a strip from the upper leaf of the external oblique aponeurosis in continuity with the muscle and suturing it with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence.
Lichtenstein's techniqueProcedure or surgery
Also called Lichtenstein's tension free mesh hernioplasty
A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring.
| Study group | Role | What they receive |
|---|---|---|
| Desarsda's technique | Experimental | These patients wil be operated by the Desarda's technique without using any prosthetic mesh. A strip of external oblique aponeurosis will be used to strengthen the defect.
Both field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia
Intervention:
A strip will be separated from the upper leaf of the external oblique aponeurosis keeping its insertion and continuity with the muscle intact. This strip will be sutured with the inguinal ligament below and the muscle arch or conjoint tendon above behind the spermatic cord to form the new inguinal floor. Continuous non absorbable prolene 2-0 suture will be used to secure it to the inguinal ligament inferiorly , and will be secured superiorly to the internal oblique muscle using interrupted absorbable vicryl sutures. Receives: Procedure: Desarda's technique |
| Lichtenstein's technique | Active comparator | These patients will be operated using prosthetic mesh described as Lichtenstein's tension free mesh hernioplasty.
Both field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia.
Intervention :
A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring. Laterally, 2 cm silt will be made through the mesh to accommodate the cord. while the two tails will be sutured to create a new deep ring made of mesh. Receives: Procedure: Lichtenstein's technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Desarda and Lichtenstien's inguinal hernia repair techniques under local anaesthesia, in terms of time taken to return to normal gait with comfort post surgery.
Time taken to return to normal gait comfortably after the surgery is calculated based on the ability to walk comfortably or move freely after surgery, as measured by ability to bend, squat, kneel ,stoop.
Measured: 7 days
Secondary outcomes (10)
Time required to return to work
time taken to resume work activities
Measured: 30 days
Early recurrence within 6 months
Appearance of bulge on the operated hernia site is treated as recurrence
Measured: 6 months
Post operative pain
it is assessed on day 8 and 30 using a visual analogue scale. A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic that ranges across a continuum of values and cant easily be directly measured. For ex,amount of pain a patient feels ranges from none to extreme amount of pain. VAS is a straight horizontal line of fixed length, 10 cm used here.It is completed by the patients themselves and helps compare the magnitude of pain at different points of time.
Here we use a scale from 0 to 10. Patient can choose any number between 0 to 10. For the convenience certain numbers are assigned pictorial depiction of pain facies with description; like : 0- no pain;2- mild, annoying pain;4- nagging, uncomfortable, troublesome pain;6- distressing, miserable pain;8- intense, dreadful, horrible pain;10- worst possible, unbearable, excruciating pain
Measured: 6 month
Presence of wound infection
Collection of purulent material at the site of incision, associated with tenderness, erythema and edema at the incision site, can be associated with systemic signs like fever and leukocytosis. It is evaluated by the investigator based on his clinical acumen and objective evidence of fever and leucocytosis
Measured: 6 months
Presence of seroma
Collection of clear serous fluid pocket at the site of incision as a result of tissue dissection , found on aspiration of fluctuant swelling at wound site or expressed after staple removal. It is evaluated by the investigator based on his clinical acumen.
Measured: 30 days
Presence of haematoma
Localised collection of blood due to vascular injury at the surgical site , found on aspiration of swelling at incision site or expressed after removal of staples.
Measured: 30 days
Loss or change in sensation in the operated groin
sensation of touch over the operated groin compared with the opposite groin to look for hyperaesthesia or allodynia
Measured: 30 days
Foreign body sensation
Patient asked if any perception of a foreign body being implanted in the operated groin is present
Measured: 6 months
Abdominal wall stiffness
Patient is asked to comment if any stiffness is felt in the abdominal wall on the operated side during locomotion or performing day to day activities
Measured: 6 months
Testicular edema/atrophy
Ultrasonography of the scrotum is done pre operatively and after 6 months of the surgery to look for any significant change in size of testes and signs of edema or atrophy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start9 Dec 2017
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernias Inguinal ReducibleStudies 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
- DESARDA'S NO MESH REPAIR: It will be performed according to the surgical technique described by Dr. Desarda. A strip will be separated from the upper leaf of the external oblique aponeurosis keeping its insertion and continuity with the muscle intact. This strip will be sutured with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. Continuous non absorbable prolene 2-0 suture will be used to secure the aponeurotic strip to the inguinal ligament inferiorly , and the strip will be secured superiorly to the internal oblique muscle using interrupted absorbable vicryl sutures. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence as it gives additional strength to the weakened internal oblique and transverses abdominis muscles.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Dr. Prakash Ku Sasmal, MBBS,MS,FNB, Principal investigator, Associate Professor, Dept. of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512366
- Sponsor's protocol ID
- IECAIIMSBBSRPGThesis/17-18/38
- Status last verified
- Oct 2020
- First submitted
- 14 Mar 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szopinski J, Dabrowiecki S, Pierscinski S, Jackowski M, Jaworski M, Szuflet Z. Desarda versus Lichtenstein technique for primary inguinal hernia treatment: 3-year results of a randomized clinical trial. World J Surg. 2012 May;36(5):984-992. doi: 10.1007/s00268-012-1508-1.
PubMed 22392354Sasmal PK, Sahoo A, Mishra TS, Das Poddar KK, Ali SM, Singh PK, Kumar P. Feasibility and outcomes of Desarda vs Lichtenstein hernioplasty by local anesthesia for inguinal hernia: a noninferiority randomized clinical trial. Hernia. 2023 Oct;27(5):1155-1163. doi: 10.1007/s10029-023-02837-5. Epub 2023 Jul 15.
PubMed 37452974
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03512366
- Acronym / sponsor ID
- IECAIIMSBBSRPGThesis/17-18/38
- Conditions
- Hernias Inguinal Reducible, Local Anaesthesia
- Keywords
- inguinal hernia, lichtenstein's technique, desarda's technique, local anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 9 Dec 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 30 Apr 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.
Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of hernia repair under local anaesthesia in terms of feasibility, economic benefits, faster ambulation with less complications. The purpose of the study is to find a method that will lead to faster disposal of patients and early return to activities, thereby reducing the waiting list of patients that compromises their financial and social spheres and overwhelms the welfare system.
Detailed description
Inguinal hernia is one of the most common treatable surgical conditions. The synthetic prostheses most often used in the inguinal area may in some cases create new clinical problems, such as foreign body sensation in the groin, discomfort, and abdominal wall stiffness, surgical site infections, migration of mesh and may affect procreation and sexual function, The cost and availability of mesh prostheses in smaller towns and underdeveloped regions proves to be a major hindrance. The requirement of the hour is to find a technique that is simple, cost effective, easy to perform, does not require extensive dissection or use of a foreign body, and also gives an acceptable recurrence rate without any major intra or post-operative complications and can be performed as a day care procedure to reduce the burden of cases in our community. A possible option for this is the Desarda method, presented in 2001, which uses an undetached strip of aponeurosis of the external oblique muscle instead of a mesh and has shown to have promising results in studies conducted so far. Several retrospective and randomized controlled trials have shown that local anaesthesia provides the best clinical and economic benefits to patients undergoing inguinal hernia repair. As there have been no studies till date comparing the outcomes for patients operated by these methods under local anaesthesia only, hence this study has been planned to assess if Desarda's technique is suitable to be used as a day care procedure with early return to normal activities after surgery, less post operative discomfort and minimum dose of analgesics and acceptable recurrence rates. This will help reduce the burden of the hospitals as these patients can be operated on a day care basis with minimal discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- DESARDA'S NO MESH REPAIR: It will be performed according to the surgical technique described by Dr. Desarda. A strip will be separated from the upper leaf of the external oblique aponeurosis keeping its insertion and continuity with the muscle intact. This strip will be sutured with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. Continuous non absorbable prolene 2-0 suture will be used to secure the aponeurotic strip to the inguinal ligament inferiorly , and the strip will be secured superiorly to the internal oblique muscle using interrupted absorbable vicryl sutures. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence as it gives additional strength to the weakened internal oblique and transverses abdominis muscles.
| Arm | Type | Receives |
|---|---|---|
| Desarsda's technique | Experimental | Procedure: Desarda's techniqueThese patients wil be operated by the Desarda's technique without using any prosthetic mesh. A strip of external oblique aponeurosis will be used to strengthen the defect. Both field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia Intervention: A strip will be separated from the upper leaf of the external oblique aponeurosis keeping its insertion and continuity with the muscle intact. This strip will be sutured with the inguinal ligament below and the muscle arch or conjoint tendon above behind the spermatic cord to form the new inguinal floor. Continuous non absorbable prolene 2-0 suture will be used to secure it to the inguinal ligament inferiorly , and will be secured superiorly to the internal oblique muscle using interrupted absorbable vicryl sutures. |
| Lichtenstein's technique | Active comparator | Procedure: Lichtenstein's techniqueThese patients will be operated using prosthetic mesh described as Lichtenstein's tension free mesh hernioplasty. Both field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia. Intervention : A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring. Laterally, 2 cm silt will be made through the mesh to accommodate the cord. while the two tails will be sutured to create a new deep ring made of mesh. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary uncomplicated inguinal hernia
- Male patients aged more than 18 years and less than 80 years
- BMI less than 30kg/sq m
- American Society of Anaesthesiologists (ASA) scale less than III
Key exclusion criteria (5 listed)
- Patients with recurrent, irreducible or strangulated inguinal hernias
- Patients unable to interpret VAS or give consent
- Patients participating in other clinical trials
- Patients with infection in the inguinal region or epididymo-orchitis
- Patients allergic to local anaesthetics
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's techniqueAlso: Desarda's No mesh repairIt will be performed by separating a strip from the upper leaf of the external oblique aponeurosis in continuity with the muscle and suturing it with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence. | Procedure or surgery | Desarsda's technique |
| Lichtenstein's techniqueAlso: Lichtenstein's tension free mesh hernioplastyA 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring. | Procedure or surgery | Lichtenstein's technique |
Primary outcome
To compare Desarda and Lichtenstien's inguinal hernia repair techniques under local anaesthesia, in terms of time taken to return to normal gait with comfort post surgery.
Time frame: 7 days
Time taken to return to normal gait comfortably after the surgery is calculated based on the ability to walk comfortably or move freely after surgery, as measured by ability to bend, squat, kneel ,stoop.
10 secondary outcomes
Time required to return to work
Time frame: 30 days
Early recurrence within 6 months
Time frame: 6 months
Post operative pain
Time frame: 6 month
Presence of wound infection
Time frame: 6 months
Presence of seroma
Time frame: 30 days
Presence of haematoma
Time frame: 30 days
Loss or change in sensation in the operated groin
Time frame: 30 days
Foreign body sensation
Time frame: 6 months
Abdominal wall stiffness
Time frame: 6 months
Testicular edema/atrophy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 22392354Szopinski J, Dabrowiecki S, Pierscinski S, Jackowski M, Jaworski M, Szuflet Z. Desarda versus Lichtenstein technique for primary inguinal hernia treatment: 3-year results of a randomized clinical trial. World J Surg. 2012 May;36(5):984-992. doi: 10.1007/s00268-012-1508-1.
- Derived from this study: PubMed 37452974Sasmal PK, Sahoo A, Mishra TS, Das Poddar KK, Ali SM, Singh PK, Kumar P. Feasibility and outcomes of Desarda vs Lichtenstein hernioplasty by local anesthesia for inguinal hernia: a noninferiority randomized clinical trial. Hernia. 2023 Oct;27(5):1155-1163. doi: 10.1007/s10029-023-02837-5. Epub 2023 Jul 15.
- Individual participant dataSharing planned: No
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.
Dr. Prakash Ku Sasmal, MBBS,MS,FNB principal investigator
Associate Professor, Dept. of General Surgery
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's technique and Lichtenstein's technique in people with Hernias Inguinal Reducible and Local Anaesthesia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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 5 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 19 Oct 2020. 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 India. 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?
Contact Dr. Prakash K. Sasmal, MBBS,MS,FNB (9438884255, drpksasmal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare Desarda and Lichtenstien's inguinal hernia repair techniques under local anaesthesia, in terms of time taken to return to normal gait with comfort post surgery. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512366, which also lists 2 linked publications.
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 19 Oct 2020.