- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03512366
Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia
Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Odisha
-
Bhubaneswar, Odisha, India, 751019
- Recruiting
- All India Institute of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desarsda's technique
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. |
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.
Other Names:
|
Active Comparator: Lichtenstein's technique
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time required to return to work
Time Frame: 30 days
|
time taken to resume work activities
|
30 days
|
Early recurrence within 6 months
Time Frame: 6 months
|
Appearance of bulge on the operated hernia site is treated as recurrence
|
6 months
|
Post operative pain
Time Frame: 6 month
|
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 |
6 month
|
Presence of wound infection
Time Frame: 6 months
|
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
|
6 months
|
Presence of seroma
Time Frame: 30 days
|
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.
|
30 days
|
Presence of haematoma
Time Frame: 30 days
|
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.
|
30 days
|
Loss or change in sensation in the operated groin
Time Frame: 30 days
|
sensation of touch over the operated groin compared with the opposite groin to look for hyperaesthesia or allodynia
|
30 days
|
Foreign body sensation
Time Frame: 6 months
|
Patient asked if any perception of a foreign body being implanted in the operated groin is present
|
6 months
|
Abdominal wall stiffness
Time Frame: 6 months
|
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
|
6 months
|
Testicular edema/atrophy
Time Frame: 6 months
|
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
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr. Prakash Ku Sasmal, MBBS,MS,FNB, Associate Professor, Dept. of General Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IECAIIMSBBSRPGThesis/17-18/38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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