Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03512366
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2018-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "DESARDA'S NO MESH REPAIR:\n\nIt 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."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.", 'timeFrame': '7 days', '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.'}], 'secondaryOutcomes': [{'measure': 'Time required to return to work', 'timeFrame': '30 days', 'description': 'time taken to resume work activities'}, {'measure': 'Early recurrence within 6 months', 'timeFrame': '6 months', 'description': 'Appearance of bulge on the operated hernia site is treated as recurrence'}, {'measure': 'Post operative pain', 'timeFrame': '6 month', '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.\n\nHere 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'}, {'measure': 'Presence of wound infection', 'timeFrame': '6 months', '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'}, {'measure': 'Presence of seroma', 'timeFrame': '30 days', '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.'}, {'measure': 'Presence of haematoma', 'timeFrame': '30 days', '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.'}, {'measure': 'Loss or change in sensation in the operated groin', 'timeFrame': '30 days', 'description': 'sensation of touch over the operated groin compared with the opposite groin to look for hyperaesthesia or allodynia'}, {'measure': 'Foreign body sensation', 'timeFrame': '6 months', 'description': 'Patient asked if any perception of a foreign body being implanted in the operated groin is present'}, {'measure': 'Abdominal wall stiffness', 'timeFrame': '6 months', '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'}, {'measure': 'Testicular edema/atrophy', 'timeFrame': '6 months', '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inguinal hernia', "lichtenstein's technique", "desarda's technique", 'local anaesthesia'], 'conditions': ['Hernias Inguinal Reducible', 'Local Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '22392354', 'type': 'BACKGROUND', '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):984-992. doi: 10.1007/s00268-012-1508-1.'}, {'pmid': '37452974', 'type': 'DERIVED', 'citation': 'Sasmal 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male patients are only included in the trial', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary uncomplicated inguinal hernia\n* Male patients aged more than 18 years and less than 80 years\n* BMI less than 30kg/sq m\n* American Society of Anaesthesiologists (ASA) scale less than III\n\nExclusion Criteria:\n\n* Patients with recurrent, irreducible or strangulated inguinal hernias\n* Patients unable to interpret VAS or give consent\n* Patients participating in other clinical trials\n* Patients with infection in the inguinal region or epididymo-orchitis\n* Patients allergic to local anaesthetics'}, 'identificationModule': {'nctId': 'NCT03512366', 'briefTitle': "Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia", 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences, Bhubaneswar'}, 'officialTitle': "Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial", 'orgStudyIdInfo': {'id': 'IECAIIMSBBSRPGThesis/17-18/38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Desarsda's technique", '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.\n\nBoth field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia\n\nIntervention:\n\nA 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.", 'interventionNames': ["Procedure: Desarda's technique"]}, {'type': 'ACTIVE_COMPARATOR', 'label': "Lichtenstein's technique", 'description': "These patients will be operated using prosthetic mesh described as Lichtenstein's tension free mesh hernioplasty.\n\nBoth field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia.\n\nIntervention :\n\nA 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.", 'interventionNames': ["Procedure: Lichtenstein's technique"]}], 'interventions': [{'name': "Desarda's technique", 'type': 'PROCEDURE', 'otherNames': ["Desarda's No mesh repair"], '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.', 'armGroupLabels': ["Desarsda's technique"]}, {'name': "Lichtenstein's technique", 'type': 'PROCEDURE', 'otherNames': ["Lichtenstein's tension free mesh hernioplasty"], '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.', 'armGroupLabels': ["Lichtenstein's technique"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '751019', 'city': 'Bhubaneswar', 'state': 'Odisha', 'status': 'RECRUITING', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}], 'centralContacts': [{'name': 'Dr. Prakash K. Sasmal, MBBS,MS,FNB', 'role': 'CONTACT', 'email': 'drpksasmal@gmail.com', 'phone': '9438884255'}, {'name': 'Dr. Ankit Sahoo, MBBS', 'role': 'CONTACT', 'email': 'ankitsahoo@gmail.com', 'phone': '7504294760'}], 'overallOfficials': [{'name': 'Dr. Prakash Ku Sasmal, MBBS,MS,FNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, Dept. of General Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Bhubaneswar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOCIATE PROFESSOR, DEPT. OF GENERAL SURGERY', 'investigatorFullName': 'Dr. Prakash Kumar Sasmal', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Bhubaneswar'}}}}