RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF DISSERTATION
TOPIC
A COMPARATIVE STUDY BETWEEN LIGHT AND HEAVY POLYPROPYLENE MESH IN LICHTENSTEIN REPAIR OFINGUINAL HERNIA.
DR. SRIDHAR SURESH
POSTGRADUATE
DEPARTMENT OF GENERAL SURGERY
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL,
HOSKOTE, BANGALORE-562114.
GUIDE-
Dr. ANANTHARAMAN.D
PROFESSOR, MVJMC & RH.
ANNEXURE- I
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the CandidateAnd
Address : / Dr. SRIDHAR SURESH,
ROOM NO E-12, RESIDENT QUARTERS,
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL,
DANDUPALYA, KOLATHUR POST
HOSKOTE, BANGALORE-562114.
2. / Name of the Institution: / MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL.
3. / Course of study and subject: / M.S. GENERAL SURGERY
4. / Date of admission and course: / 22/07/2013 (Three years)
5. / Title of the Topic: / A COMPARATIVE STUDY BETWEEN LIGHT AND HEAVY POLYPROPYLENE MESH IN LICHTENSTEIN REPAIR OF INGUINAL HERNIA.
6. / Brief resume of the intended work:
6.1 Need for the study:
Inguinal hernia repair is one of the most common surgical procedure performed in practice. Although numerous techniques have been described, currently tension free mesh repair is the standard of care in the treatment of hernias because of the low recurrence rates. However chronic pain, foreign body sensation, stiff lower abdominal wall have been variably reported in patients. Experimental studies have hypothesised that the inflammatory reaction and scar tissue formation caused by the mesh is responsible for the high incidence of postoperative pain. Material-reduced large porous non absorbable light weight mesh have reduced these complications. However this needs to be confirmed by randomized studies and hence this study will evaluate the effect of light weight mesh on these parameters.
6.2 Review of literature:
Hernia (Greek kele/hernios--bud or offshoot) was present in the human history from its very beginning. The turning point in hernia surgery was discovery of synthetic polymers by Carothers in 1935. Usher in 1959 introduced use of mesh in hernia repair. The first tensionless technique described by Lichtenstein was based on strengthening of the posterior wall of inguinal canal with prosthetic material. Lichtenstein published the data on 1,000 operations with Marlex mesh without any recurrence in 5 years after surgery. Thus new rule of groin hernia repair was introduced--tensionless repair. Another treatment method was popularized by Rene Stoppa, who used Dacron mesh situated in preperitoneal space without fixing sutures. First such operation was performed in 1975, and reported recurrence rates were quite low (1.4%). The next step was introduction of a Prolene Mesh which had properties showing minimal tissue reactivity and high durability. Since 1995 various studies on abdominal wall mobility and textile design on mesh was undertaken and many modifications made and tried.(1)
Today the meshes used are typically made from polypropylene. The original first generation of meshes described for the treatment of hernias were of the heavy type with a smaller pore size,greater weight/area, lesser elasticity and higher burst pressure. The latter generation of meshes included the light weight meshes with larger pore size resulting in smaller interface between the mesh and surrounding tissues, low weight per area, greater elasticity and a lower burst pressure.(2)
It has been surmised that the inflammatory reaction to the foreign material is correlated with the amount and structure (i.e., pore size) of the synthetic material inserted.Tension- free repair with non-absorbable mesh (polypropylene) has been used in a higher number of cases during the past few years.(2)
The most important properties of meshes were found to be the type of filament, tensile strengthand porosity. These determine the weight of the mesh and its biocompatibility. The tensile strength required is much less thanoriginally presumed and light-weight meshes are thought to be superior due to their increased flexibility and reduction in discomfort.Large pores are also associated with a reduced risk of infection and shrinkage. For meshes placed in the peritonealcavity, consideration should also be given to the risk ofadhesion formation. A variety of composite meshes have been promotedto address this, but none appears superior to the others.(3)
When meshes are categorized by density, a mesh with density >100 g/m2 is accepted as heavy, whereas a 35-50 g/m2 density is classified as lightweight. Several recentcontrolled clinical studies have suggested that lightweight meshes may improve patient comfort(4)
In a study consisting of 220 patients comparing outcomes of light to heavy polypropylene mesh in 60 months, the recurrence rate did not differ statistically. Less pain on the 7th postoperative day, and at 3 months, was observed in the light weight mesh group. No other differences were observed .Use of a lightweight non-woven polypropylene
implant is a valuable alternative to the use of knitted or woven meshes in the Lichtenstein method. Postoperative pain and recurrence were reduced at short term follow-up, but no statistical difference in recurrence rate was observed at 12 and 60 month follow-up in the patient population tested(5)
Both the light, partially absorbable mesh and the heavy, non-absorbable mesh used in the Lichtenstein technique are equally effective for prevention of inguinal hernia recurrence. Light, partially absorbable mesh vs. heavy, non-absorbable mesh results in lower intensity of chronic pain, lower risk and intensity of postoperative ailments, faster return to normal activities of daily living and sport as well as higher satisfaction with treatment. The type of mesh has no effect on surgery duration, risk of intraoperative and early postoperative complications, or pain intensity in the early postoperative period(6)
6 .2 Objective Of The Study: To compare and analyse the difference between heavy and light polypropylene mesh for the following outcomes.
1) Foreign body sensation.
2) Chronic Pain.
3) Recurrence.
4) Patient post – operative recovery time and return to normal activities
7. / Materials and Methods:
7.1 Source of data:
Study includes patients admitted in surgery department MVJMC&RH ,Hoskote foringuinal hernia.
7.2 Method of collection of data(including sampling procedure if any):
1)Definition of a study subject:
60patients satisfying the inclusion criteria and admitted for Lichtenstein inguinal hernia repair in Department of Surgery, MVJMC&RH
.The method of study consists of
· Detailed history taking & clinical examination as per the proforma.
· Investigations after taking written informed consent.
· Patients who are undergoing elective Lichtenstein inguinal hernia repair are divided into two groups using randomization by equal allocation.
First Group (A):
Included are30 patients in whom the light weight polypropylenemesh is used by Lichtenstein's technique of tension free mesh repair.
Second Group(B):
Included are 30 patients in whom the Heavyweight propylene mesh is used by the Lichtenstein's technique of tension free mesh repair.
· Patients will be followed up post operatively at the end of 2 weeks, 1 Month, 3 Months and 6 Months for recurrence, foreign body sensation, pain and return to normal activities.
· Patients complaining of persistent pain at the operative site during the 3rd month follow up will be considered as having chronic pain.
· Patients will be taken for Ultrasonography on 2nd 3rd and 4th follow up visits for determining local tissue reaction/subclinical recurrence and mesh shrinkage.
2. InclusionCriteria:
· Uni or bilateral inguinal hernia of either sex
· Age more than 18yrs.
3.Exclusion Criteria :
· Patients without consent.
· Complicated inguinal hernias.
· Recurrent Hernias
· Femoral Hernia.
· Cases with previous history of explantation of mesh.
· Patients with active infection in the inguinal region.
4. Statistical Calculation:
Statistical calculations will be done by help of Chi –Squared test with degree of significance <5%.
7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals?
No investigations or interventions will be conducted on animals. Only routine investigations will be conducted on the patients to assess fitness for anesthesia and surgery.
The following investigations will be done after taking written informed consent-
1. Routine Investigations for General Surgical Procedure
Blood Investigation and Urine Investigations :
1)Hb% 7) Lipid Profile
2) TC 8) FBS/PPBS
3) DC 9) HIV &HBsAg
4) ESR 10) Urine Microscopy
5) Renal function tests 11) APTT/PT
6) Liver function tests
Other investigations :
1)X-ray of the chest
2) Ultra Sonogram of Abdomen and Pelvis when indicated.
3) Post-operative ultrasound of the operated site
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES
8. / List of references:
1. Legutko J, Pach R, Solecki R, Matyja A, Kulig J.The history of treatment of groin hernia. Folia Med Cracov. 2008;49(1-2):57-74.
2.Khan.N, Bangash.A, Muzaffaruddin.S, Ain.U.H, and Haris.H. Polyglactine/Polypropylene Mesh vs. Propylene Mesh: Is There a Need for Newer Prosthesis in Inguinal Hernia? Saudi J Gastroenterol. 2010 Jan-Mar; 16(1): 8–13.
3.Brown.C.N,Finch.J.G, Which mesh for hernia repair?Ann R CollSurgEngl2010; 92: 272–278
4. Kulacoglu H. Current options in inguinal hernia repair in adult patients. Hippokratia 2011; 15 (3): 223-231
5.Jmietajski.M · Bury.K ·Jmietajska I.A · Owczuk.R·Paradowski.T · The Polish Hernia Study Group. Five-year results of a randomised controlled multi-centre study comparing heavy-weight kitted versus low-weight, non-wovenpolypropylene implants in Lichtenstein hernioplasty. Hernia (2011) 15:495–501
6. Pielaciński.K, Andrzej B. Szczepanik.L, Wróblewski.T.Effect of mesh type, surgeon and selected patients’characteristics on the treatment of inguinal hernia
with the Lichtenstein technique. Randomized trial. VideosurgeryMiniinv 2013; 8 (2): 99-106
9. / Signature of Candidate :
10. / Remarks of the Guide:
The long-term consequences of implantable polypropylene heavy mesh are not without concern. The body generates an intense inflammatory response to the mesh that results in scar plate formation, increased stiffness of the abdominal wall, and shrinkage of the biomaterial. Reducing the density of polypropylene and creating a "light weight" mesh theoretically induces less foreign-body response, results in improved abdominal wall compliance, causes less contraction or shrinkage of the mesh, and allows for better tissue
Incorporation. A review of clinical follow-up is required to provide a strong basis or argument for the use of light weight mesh in Lichtenstein’s Inguinal Hernia Repair hence its a valuable study.
11. / Name & Designation of
(in block letters)
11.1 Guide
11.2 Signature / DR.ANANTHARAMAN.DMBBS MS,
PROFESSOR ,
Department of General Surgery,
M.V.J Medical College And Research Hospital
11.3 Co-Guide
11.4 Signature / DR. DAYANANDA KUMAR
MBBS MD(Radio diagnosis)
Associate Professor
Department Of Radio diagnosis and Imaging
M.V.J Medical College and Research Hospital
11.5 Head of Department
11.6 Signature / DR. P. SUDARSHANMBBS MS,
PROFESSOR & HEAD OF DEPARTMENT,
Department of General Surgery,
M.V.J Medical College And Research Hospital.
12 / 12.1 Remarks of the chairman & principal
12.2 Signature
PROFORMA
Ø Name :
Ø Age : Sex:
Ø IP.NO :
Ø Address :
Ø Date of admission :
Ø Date of operation :
Ø Date of discharge :
Ø Nutritional status :
Ø Pre-operative status :
· Anemia
· Jaundice
· Diabetes Mellitus.
· Malignancies
· Immunity Status
· Patient on Steroids or Chemotherapy
· Hypo-proteinemia
· Obesity
· Smoking
· Chronic Inflammatory Conditions.
Ø Pre-operative diagnosis(Type of Hernia)
Ø Investigations :
· HB%
· TC
· DC
· Urine - Sugar
- Albumin
-Ketone bodies
-Microscopy
· Renal Function Test - Blood Urea.
- Serum Creatinine.
· Random Blood Sugar
· Serum Electrolytes
· Liver Function Tests
· HIV
· HBsAg
· X-Ray - Chest
Ø Type of antibiotic :
· Pre-Operative
· Per-Operative
· Post-Operative
Ø Surgery Done on
Ø Details of Surgical Procedure
· Anaesthesia
· Antiseptic used for draping
· Incision
· Surgical Procedure
· Type of Drain used -Yes/No
· Suture materials used
· Type of Closure
· Duration of Surgery.
Ø Post-operative Status :
Ø Result.
Patient Status on Follow up(2 weeksform operative day) :
1)Foreign Body Sensation in Inguinal Area.
2) Chronic Pain:
Mild-
Moderate-
Severe-
Duration-
3) Stiffness over Abdominal wall
4) Recurrence
Patient Status on Follow up (1 month form operative day) :
1) Foreign Body Sensation in Inguinal Area.
2) Chronic Pain:
Mild-
Moderate-
Severe-
Duration-
3) Stiffness over Abdominal wall
4) Recurrence
Patient Status on Follow up (3months form operative day) :
1) Foreign Body Sensation in Inguinal Area.
2) Chronic Pain:
Mild-
Moderate-
Severe-
Duration-
3) Stiffness over Abdominal wall
4) Recurrence
Patient Status on Follow up (6 months form operative day) :
1) Foreign Body Sensation in Inguinal Area.
2) Chronic Pain:
Mild-
Moderate-
Severe-
Duration-
3) Stiffness over Abdominal wall
4) Recurrence
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL,
HOSKOTE, BANGALORE-562114.
INFORMED CONSENT FORM
TOPIC
“A COMPARATIVE STUDY BETWEEN LIGHT POLYPROPYLENE MESH AND HEAVY POLYPROPYLENE MESH IN LICHTENSTEIN REPAIR OF INGUINAL HERNIA.”
I ……………………………….…………………………. declare that I have been briefed and hereby consent to be included as a subject in the following dissertation " A COMPARATIVE STUDY BETWEEN LIGHT POLYPROPYLENE MESH AND HEAVY POLYPROPYLENE MESH IN LICHTENSTEIN REPAIR OF INGUINAL HERNIA." I have been informed to my satisfaction by the attending doctor,Dr. Sridhar Suresh the purpose of the study and also investigations that may be required. This has been explained to me in the language I understand and I fully consent for the same.
SIGNATURE OF DOCTOR SIGNATURE OF PATIENT/RELATIVE
NAME OF THE DOCTOR NAME
RELATIONSHIP
DATE DATE
/ /2013
Bangalore.
From,
Dr. Sridhar Suresh
Postgraduate Student,
Department of General Surgery,
MVJ Medical College&Research Hospital.
To,
The Secretary,
Institution Ethics Committee,
MVJ Medical College&Research Hospital.
Respected Sir,
Subject: Regarding ethical clearance for my thesis.
I Dr. Sridhar Sureshwill be doing dissertation work as part of my postgraduate course in M.S.General Surgery, the topic being “A COMPARATIVE STUDY BETWEEN LIGHT POLYPROPYLENE MESH AND HEAVY POLYPROPYLENE MESH IN LICHTENSTEIN REPAIR OF INGUINAL HERNIA” under the guidance of Prof Dr.Anantharaman D. In this study I will be observing 60 patients from November 2013 to November 2015 in our hospital.
I request you to kindly grant me the ethical clearance for this study and oblige.
Thanking you,
Yours obediently,
Dr. Sridhar Suresh