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Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia

Primary Purpose

Hernias Inguinal Reducible, Local Anaesthesia

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Desarda's technique
Lichtenstein's technique
Sponsored by
All India Institute of Medical Sciences, Bhubaneswar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernias Inguinal Reducible focused on measuring inguinal hernia, lichtenstein's technique, desarda's technique, local anaesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • All India Institute of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desarsda's technique

Lichtenstein's technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time required to return to work
time taken to resume work activities
Early recurrence within 6 months
Appearance of bulge on the operated hernia site is treated as recurrence
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
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
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.
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.
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
Foreign body sensation
Patient asked if any perception of a foreign body being implanted in the operated groin is present
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
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

Full Information

First Posted
March 14, 2018
Last Updated
October 15, 2020
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
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1. Study Identification

Unique Protocol Identification Number
NCT03512366
Brief Title
Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia
Official Title
Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2017 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Bhubaneswar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernias Inguinal Reducible, Local Anaesthesia
Keywords
inguinal hernia, lichtenstein's technique, desarda's technique, local anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
This will be a double blind trial .The patient will not be revealed about the technique being performed. The investigator who will follow up the patients post operatively in the out-patient clinic will also be blinded about the procedure performed on the patient.
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Desarsda's technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Lichtenstein's technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Desarda's technique
Other Intervention Name(s)
Desarda's No mesh repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein's technique
Other Intervention Name(s)
Lichtenstein's tension free mesh hernioplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Time required to return to work
Description
time taken to resume work activities
Time Frame
30 days
Title
Early recurrence within 6 months
Description
Appearance of bulge on the operated hernia site is treated as recurrence
Time Frame
6 months
Title
Post operative pain
Description
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
Title
Presence of wound infection
Description
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
Title
Presence of seroma
Description
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
Title
Presence of haematoma
Description
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
Title
Loss or change in sensation in the operated groin
Description
sensation of touch over the operated groin compared with the opposite groin to look for hyperaesthesia or allodynia
Time Frame
30 days
Title
Foreign body sensation
Description
Patient asked if any perception of a foreign body being implanted in the operated groin is present
Time Frame
6 months
Title
Abdominal wall stiffness
Description
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
Title
Testicular edema/atrophy
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients are only included in the trial
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Prakash K. Sasmal, MBBS,MS,FNB
Phone
9438884255
Email
drpksasmal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Ankit Sahoo, MBBS
Phone
7504294760
Email
ankitsahoo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Prakash Ku Sasmal, MBBS,MS,FNB
Organizational Affiliation
Associate Professor, Dept. of General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751019
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22392354
Citation
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):984-92. doi: 10.1007/s00268-012-1508-1.
Results Reference
background

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Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia

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