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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
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.
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.
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India
RECRUITINGTo 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.
Time frame: 7 days
Time required to return to work
time taken to resume work activities
Time frame: 30 days
Early recurrence within 6 months
Appearance of bulge on the operated hernia site is treated as recurrence
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 30 days
Foreign body sensation
Patient asked if any perception of a foreign body being implanted in the operated groin is present
Time frame: 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
Time frame: 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
Time frame: 6 months
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