comparative study of fibrin glue versus sutured MESH fixation for LICHTENTEIN INGUINAL REPAIR

comparative study of fibrin glue versus sutured MESH fixation for LICHTENTEIN INGUINAL REPAIR

1. PROTOCOL OF RESEARCH "COMPARATIVE STUDY OF FIBRIN GLUE VERSUS SUTURED MESH FIXATION FOR LICHTENSTEIN INGUINAL HERNIA REPAIR" Submitted By:- DR. SATYANARAYAN V

2. GUIDES PRINCIPAL INVESTIGATOR- Proff Dr.Satyanarayan V CO-INVESTIGATOR- Proff Dr.Hemanth S Ghalige

3. INTRODUCTION Inguinal hernia repair is one of the most frequently performed surgical operations.The most commonly performed inguinal hernia repair today is the Lichtenstein repair.a flat mesh is placed on top of defect,it is a "tension-free" repair that doesn't put tension on muscles.(1)ln recent years,mesh fixation using fibrin glue instead of sutures has become popular.Both clinical and experimental trials demonstrate that fibrin sealant is a feasible option for mesh fixation in hernia.(2)

4. Aims and objecTs of study : The main objective of the study is to investigate short-term outcome and chronic groin pain and Recurrence like Post operative pain Post-operative analgesia requirement within 24 hours. Operation time Hematoma,seroma formation Ambulation time

5. Materials and methods Patients admitted with inguinal hernia(direct/indirect, bilateral or unilateral or strangulated) at ESIC PGIMSR, R ajajinagar , Banglore-10.

6. Study design: prospective study . Study Period: From Nov 201 6 to A pril 201 8 . Sampling Technique: minimum 60 cases sample size Ethical issues: The study will be carried out only after obtaining approval from institutional ethical committee(IEC), ESIC , Bangalore.

7. Inclusion Criteria: All cases of inguinal hernia admitted for surgery
1. Above 18 years of age.
2. With a primary, reducible inguinal or inguino-scrotal hernia; unilateral or bilateral or str angulated hernia .

8. EXCLUSION CRITERIA: Old and debilitated patients of poor general condition as they will be unable to give an accurate assessment of the key outcomes of the operation. Recurrent Hernias.

9. Methods: Patients with Inguinal hernia who are admitted in all the Surgery units are taken in the study. A written valid informed consent from subject will be taken. Detailed history and physical examination will form the basis of the study, findings are recorded using standard proforma .

10. Pa tients will undergo necessary investigations including blood routine including Heamoglobin,Total count,Differential count,Erythrocite sedimentation rate,Platelet count,Bleeding time, Cloting time and Biochemical routine including Blood Urea, Serum creatinine,Serum electrolyte and urine analysis. Chest Xray and Electrocardiography.
Any other investigations will be done if required based on history and other complaints .

11. STATISTICS Sampling procedure: Randomised controlled Trail Sample size: Considering mean difference in time taken for surgery to be 8.8 minutes between F and L group with 95% CI and 80% power our sample size will be 30 in each group. Considering 10% nonresponse rate and 10% loss to follow up we will include 36 in each group. Sample size calculated using OpenEpi version 3.03.

12. PARTICIPANT CONSENT FORM Participant’s name: Address : TITLE OF THE PROJECT: " COMPARATIVE STUDY OF FIBRIN GLUE VERSUS SUTURED MESH FIXATION FOR LICHTENSTEIN INGUINAL HERNIA REPAIR " The details of the study have been provided to me in writing and explained to me in my own language. I confirm that I have understood the above study and had the opportunity to ask questions. I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without giving any reason, without the medical care that will normally be provided by the hospital being affected. I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s). I have been given an information sheet giving details of the study. I fully consent to participate in the above study. ( Participant) (Date) (Witness to signature) (Date)

13. References 1.Rutkow IM, Robbins aW : Demographic, classificatiory , and socioeconomic aspects of hernia repair in the United states.Surg Clin North Am, 1993;73:413-26. 2.Amid PK,Shulman AG, Lichtenstein IL: A critical evaluation of Lichtenstein tension-free hernioplasty.Int Surg , 1994;79:76-79. 3.Lichtenstein IL:herniorrhaphy . A personal experience with 6321 cases. A j Surg,1987;153:553-59. 4.McCormack K, Scott NW, Go PM, Ross S, Grant AM EU:Hernia Trailists Collaboration . Laparoscopic techniques versus open techniques for inguinal hernia repair . Cochrane database syst Rev 2003; CD001785.

14. 5.Verstrate L swannet H:long-term follow-up after Lichtenstein hernioplasty in a general surgical unit.hernia , 2003; 7:185-90. 6.Kumar s,Wilson RG, Nixon SJ, Macintyre IM:Chronic pain after laparoscopic and open mesh repair of groin hernia.Br j surg,2002; 89:1476-479 . 7.Poobalan AS, Bruce J, Smith WC, King PM,Krukowski ZH, Chambers WA:A review of chronic pain after inguinal herniorrhaphy . Clin J Pain,2003;19:48-54. 8.Canonico S, Sciaudone G, PaciWco F, Santoriello A; Inguinal hernia repair in patients with coagulation problems; prevention of postoperative bleeding with human fibringlue.surg,1999;125:315-17.

15. Summary The study will be carried out in the Department of Surgery ESIC PGIMS, Rajajinagar , Banglore-10 for a period of two years with due approval of institutional ethical committee. The study population will be 60 (cases) patients with Inguinal henia confirmed by clinical examination and laboratory results, admitted to the surgical wards of ESIC PGIMSR Rajajinagar , Banglore . The study will attempt to compare short term outcomes and recurency rate between sutured mesh fixation and fibrin glue technique for Lichtenstein hernia repair. At the end of study, the final assessment is done using standard analytical method .

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