PROFORMA FOR REGISTRATION OF SUBJECTS FOR …



PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION FOR RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BENGALURU.

DISSERTATION PROPOSAL

A COMPARATIVE STUDY OF USE OF EXTERNAL OBLIQUE APONEUROSIS FOR STRENGTHENING OF POSTERIOR WALL OF INGUINAL CANAL(NO MESH DESARDA'S TECHNIQUE) VS CONVENTIONAL HERNIA REPAIR WITH MESH (LICHTENSTEINS REPAIR)

SUBMITTED BY,

Dr. HEMANTH VUPPUTURI

Post Graduate 1st Year

Department of Surgery

Kempegowda Institute of Medical Sciences And Research Centre, Bengaluru- 560004

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BENGALURU, KARNATAKA.

ANNEXURE-II

SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| | | |

|1 |NAME OF THE CANDIDATE AND ADDRESS |HEMANTH VUPPUTURI |

| | |D.No 4-20-34, 4th Line 1st Cross |

| | |Navabharath Nagar, Ring Road, Guntur A.P -522006 . |

| | | |

|2 |NAME OF THE INSTITUTE |KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, |

| | |BENGALURU-560004. |

| | | |

|3 |COURSE OF STUDY AND SUBJECT |MS- GENERAL SURGERY |

| | | |

|4 |DATE OF ADMISSION TO COURSE |13/06/2013 |

|5 |TITLE OF THE TOPIC |A COMPARATIVE STUDY OF USE OF EXTERNAL OBLIQUE APONEUROSIS FOR STRENGTHENING |

| | |OF POSTERIOR WALL OF INGUINAL CANAL(NO MESH DESARDA'S TECHNIQUE) VS |

| | |CONVENTIONAL HERNIA REPAIR WITH MESH (LICHTENSTEINS REPAIR) |

BRIEF RESUME OF THE INTENDED WORK

6. INTRODUCTION:

In recent times a new procedure has been described for inguinal hernia surgery by Dr. Desarda 1 a surgeon from Pune, which involves use of a strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal. The advantages of this procedure over Lichtenstein’s are that:

➢ This is a physiological repair and tension free

➢ Pain is comparatively lower in this procedure.2,3

➢ No risk of complications in future as there is no mesh placed

➢ Can be used in strangulated hernia.4

➢ Recurrence and complication rates equal to or better than Lichtenstein’s repair.5,6

➢ Early ambulation and less time of hospital stay.2,3

➢ Low cost for the patient as mesh is not used.

➢ Simple procedure with equal or less operating time than Lichtenstein’s repair.6

Multiple studies have been done in various countries with good results comparing the procedure with mesh repair.

DESCRIPTION OF THE PROCEDURE STEP BY STEP:

1. Skin and fascia are incised through a regular oblique inguinal incision to expose the external oblique aponeurosis. The thin, filmy fascial layer covering it is kept undisturbed as far as possible and an assessment made about the strength of it and its thinned-out portion. The thinned out portion is usually seen at the top of the hernia swelling, extending and fanning out to the lower crux of the superficial ring.

2. The external oblique is cut in line with the upper crux of the superficial ring, which leaves the thinned out portion in the lower leaf so a good strip can be taken from the upper leaf. The external oblique, which is thinned out as a result of aging or long standing large hernias, can also be used for repair if it is able to hold the interrupted sutures.

3. The cremasteric muscle is incised for the herniotomy and the spermatic cord together with the cremasteric muscle is separated from the inguinal floor. The sac is excised in all cases except in small direct hernias where it is inverted.

4. The medial leaf of the external oblique aponeurosis is sutured with the inguinal ligament from the pubic tubercle to the abdominal ring using 1/0 PDS continuous sutures. The first two sutures are taken in the anterior rectus sheath where it joins the external oblique aponeurosis. The last suture is taken so as to narrow the abdominal ring sufficiently without constricting the spermatic cord. Each suture is passed first through the inguinal ligament, then the transversalis fascia, and then the external oblique. The index finger of the left hand is used to protect the femoral vessels and retract the cord structures laterally while taking lateral sutures.

5. A splitting incision is made in this sutured medial leaf, partially separating a strip with a width equivalent to the gap between the muscle arch and the inguinal ligament but not more than 2 cms. This splitting incision is extended medially up to the pubic symphisis and laterally 1–2 cms beyond the abdominal ring. The medial insertion and lateral continuation of this strip is kept intact. A strip of the external oblique, is now available, the lower border of which is already sutured to the inguinal ligament. The upper free border of the strip is now sutured to the internal oblique or conjoined muscle lying close to it with 1/0 PDS. The aponeurotic portion of the internal oblique muscle is used for suturing to this strip wherever and whenever possible to avoid tension; otherwise, it is not a must for the success of the operation. This will result in the strip of the external oblique being placed behind the cord to form a new posterior wall of the inguinal canal.

6.The spermatic cord is placed in the inguinal canal and the lateral leaf of the external oblique is sutured to the newly formed medial leaf of the external oblique in front of the cord, as usual, again using 1/0 PDS continuous sutures. Undermining of the newly formed medial leaf on both of its surfaces facilitate its approximation to the lateral leaf. The first stitch is taken between the lateral corner of the splitting incision and lateral leaf of the external oblique. This is followed by closure of the superficial fascia and the skin as usual.

6.1 NEED FOR THE STUDY

• Since few decades Lichtenstein's mesh repair has been the standard of care in inguinal hernia surgery. Millions of people have undergone this procedure throughout the world.

• Though many alternative procedures were there mesh placement had the advantages of:

Being technically simple,

Easy to perform,

Tension free,

Less painful and had low recurrence rate compared to other older procedures.

• However Lichtenstein’s repair had its own limitations.

➢ It was unphysiological as it involved placing a foreign body inside the inguinal canal

➢ Chronic inguinal pain (inguinodynia) 7,8,9 was common complication

➢ There was a likelihood of seroma formation10,11

➢ Patients complained of foreign body sensation10,11

➢ Risk of mesh infection, there may be risk of mesh migration or adhesion to bowel or formation of fistulas 9

➢ Progressive decrease of blood flow in cord structures 12-14, testicular atrophy, infertility12-14

➢ Use this technique in cases of strangulated hernias is not recommended 10,11

➢ There was extra cost involved of the mesh itself.

Hence an alternate procedure for inguinal hernia surgery is to be evaluated to replace Lichtenstein's repair, which is physiological, low cost and with recurrence rates equal to or better than Lichtenstein's repair.

6.2 REVIEW OF LITERATURE

1) Bailey and Love’s Short Practice of Surgery 26th Edition:

Suture repair for inguinal hernia is still under development, and recently, Desarda has described an operation where a 1-2cm strip of external oblique aponeurosis lying over the inguinal canal is isolated from the main muscle but attached both medially and laterally. It is then sutured to the conjoint tendon and inguinal ligament, reinforcing the posterior wall of inguinal canal. As the abdominal muscles contract, this strip of aponeurosis tightens to add further physiological support to the posterior wall. This operation is currently being evaluated.

2)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 journal of surgery. 2012; 36 (5): 984--992.

Subjects: 208

Follow up period: Three years

Results: During the follow-up, two recurrences were

Observed in each group (p = 1.000). Chronic pain was

Experienced by 4.8 and 2.9% of patients from groups D and

L, respectively (p = 0.464). Foreign body sensation and

Return to activity was not different between the groups.

There was significantly less seroma production in the D

Group (p = 0.004).

Conclusions: The results of primary inguinal hernia repair

With the Desarda and Lichtenstein techniques are comparable at the 3-year follow-up. The technique may potentially increase the number of tissue-based methods

Available for treating groin hernias.

3) No-mesh Inguinal Hernia Repair with Continuous Absorbable

Sutures: A Dream or Reality? (A Study of 229 Patients)Mohan P. Desarda

Saudi Journal of Gastroenterology.

Results: A total of 224 (97.8%) patients were ambulatory within 6-8 h (mean: 6.42 h) and they attained free ambulation within 18-24 h (mean: 19.26 h). A total of 222 (96.4%) patients returned to work within 6-14 days (mean: 8.62 days) and 209 (91.26%) patients had one-night stays in the hospital. A total of 216 (94.3%) patients had mild pain for 2 days. There were four minor complications, but no recurrence or incidence of chronic groin pain. Patients

were followed up for a mean period of 24.28 months (range: 6-42 months).

Conclusions: Continuous suturing saves operative time and

one packet of suture material. The dream of every surgeon to give recurrence-free inguinal hernia repair without leaving any foreign body inside the patient may well become a reality in future.

4) Physiological repair of inguinal hernia-A new technique (Study of 860 patients)Hernia. (2006) 10:143-146

(Hernia-The world journal of abdominal wall surgery, 2006)

Subjects: 860

Follow up period: 8yrs

RESULTS: Mean patient age was 50.5 years (range, 18 – 90). 851 (98.95%) patients were operated under local or regional anesthesia. 838 (97.4%) patients were ambulatory with limited movements in 6 hours and free movements in 18-24 hours. 792(92%) patients had a hospital stay of one night and 840(97.6%) patients returned to normal activities within 1-2 weeks. Hematoma formation requiring drainage was observed in 1 patient, while seven patients had wound edema during the postoperative period which subsided on its own. Follow-up was completed in 623 patients (72.5 %) by clinical examination or questionnaire. The median follow-up period was 7.8 years (range, 1 – 12 years). There was no recurrence of the hernia or postoperative neuralgia.

CONCLUSIONS: This operation is simple to perform, does not require foreign body like mesh or complicated dissection of the inguinal floor as in Bassini/Shouldice. It has shown excellent results with virtually zero recurrence rates.

6.3 AIMS & OBJECTIVES OF THE STUDY

• Aims:

• To compare the short term outcomes and recurrence rate for one year between Lichtenstein’s and Desardas technique.

• Objectives:

• To study the short term outcome in the following ways:

• Operating time

• Post operative pain

• Ambulation time

• Induration/redness  of the operated site

• Post op wound infection rate

• Discharge time

• Cost of procedure in total

To look for any recurrence with regular follow ups at one month, three months, six months and one year.

7. MATERIALS AND METHOD

7.1 SOURCES OF DATA

Patients admitted with Inguinal Hernia (direct/Indirect, Unilateral or Bilateral) at KIMS Hospital, BANGALORE.

7.1.1 RESEARCH DESIGN

A prospective study comparing two groups of patient’s one group undergoing Desarda repair and one group undergoing Lichtenstein’s repair and outcomes will be compared

7.2 METHODS OF DATA COLLECTION

Detailed history will be taken and patients will be examined thoroughly.

Patients will undergo necessary investigations including blood routine including Hb , TC, DC, ESR, PLATELET COUNT , BT, CT and Biochemical routine including B. Urea, S. creatinine, S. Electrolytes and urine analysis. Chest Xray and ECG.

Any other investigations will be done if required based on history and other complaints

Written informed consent will be obtained from all the patient with detailed explanation of the procedure going to be performed on them the risks and complications involved and the advantages and disadvantages of the same and patient will be given a choice of which procedure he wants to undergo.

The visual analog scale to be used for pain measurement will be explained in detail to the patient.

Patient will be prepared for surgery.

Patient will asked to fill a proforma detailing all the study aims and objectives

7.2.1 SAMPLING PROCEDURE

Simple random sampling technique will be used to select the sample for the study.

7.2.2 SAMPLE SIZE

A total of 60 patients will be studied, 30 of these undergoing Desardas hernia repair and 30 undergoing Lichenstien mesh repair.

CRITERIA FOR SAMPLE COLLECTION

7.2.3 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

7.2.4 EXCLUSION CRITERIA

Patients with:

1. Obstructive uropathy or chronic obstructive pulmonary disease- because they are contraindications to elective hernia surgery. They are associated with definite poor outcomes such as high recurrence rates.

2. 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.

3. Patients with strangulated hernia.

4. Recurrent Hernias.

5. Per operative finding of separated, thin and/or weak external oblique aponeurosis

7.2.5 TOOLS FOR DATA COLLECTION

Patient will be given a proforma to fill up and the objectives will be studied in detail by following up the patient for one year with periodical followup.

7.2.6 PLAN FOR DATA ANALYSIS

Data obtained will be analysed in terms of objectives of the study using descriptive and inferential statistics.

7.2.7 TIME AND DURATION OF THE STUDY

One and half years including follow up time. From November 2013 to April 2015

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENT OR OTHER HUMAN OR ANIMAL? IF SO, PLEASE DESCRIBE BRIEFLY.

YES, Patient has to undergo a surgery as a part of this study

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?

YES

8.LIST OF REFERENCES

1. Nixon S, Tulloh B. Abdominal Wall, Hernia and Umblicus. In: Williams N, Bullstrode C, O'connel P. (eds.) Bailey and Love's Short Practice of Surgery. 20th ed. London: CRC Press; 2013. p. 957-8.

2. Mitura K, Roma\'Nczuk M. Comparison between two methods of inguinal hernia surgery--Lichtenstein and Desarda].. Polski merkuriusz lekarski: organ Polskiego Towarzystwa Lekarskiego. 2008; 24 (143): 392.

3. Manyilirah W, Kijjambu S, Upoki A, Kiryabwire J. Comparison of non-mesh (Desarda) and mesh (Lichtenstein) methods for inguinal hernia repair among black African patients: a short-term double-blind RCT. Hernia. 2012; 16 (2): 133--144.

4. Situma S, Kaggwa S, Masiira N, Katumba S. Comparison of Desarda versus modified Bassini inguinal Hernia repair: a randomized controlled trial. East Cent Afr J Surg. 2009; 14: 70--76.

5. 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 journal of surgery. 2012; 36 (5): 984--992.

6. Manyilirah W. Comparison of non-mesh (Desarda) and mesh (Lichtenstein) methods for inguinal hernia repair at Mulago Hospital: a single-centre double-blind randomised controlled trial. 2009;.

7.  Amid, P. K. (2004). "Radiologic Images of Meshoma: A New Phenomenon Causing Chronic Pain After Prosthetic Repair of Abdominal Wall Hernias". Archives of Surgery 139 (12): 1297–8. 

8.  Parra, J A; Revuelta, S; Gallego, T; Bueno, J; Berrio, JI; Fariñas, MC (2004). "Prosthetic mesh used for inguinal and ventral hernia repair: Normal appearance and complications in ultrasound and CT". British Journal of Radiology 77 (915): 261–5.

9. Aguirre, D. A.; Santosa, A. C.; Casola, G.; Sirlin, C. B. (2005). "Abdominal Wall Hernias: Imaging Features, Complications, and Diagnostic Pitfalls at Multi-Detector Row CT".Radiographics 25 (6): 1501–20. 

10. Ostergard, Donald R. (2011). "Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: What was known and when it was known". International Urogynecology Journal 22 (7): 771–4. 

11. Klosterhalfen, B.; Klinge, U.; Hermanns, B.; Schumpelick, V. (2000). "Pathologie traditioneller chirurgischer Netze zur Hernienreparation nach Langzeitimplantation im Menschen" [Pathology of traditional surgical nets for hernia repair after long-term implantation in humans]. Der Chirurg (in German) 71(1): 43–51. 

12. Shin, David; Lipshultz, Larry I.; Goldstein, Marc; Barm??, Gregory A.; Fuchs, Eugene F.; Nagler, Harris M.; McCallum, Stewart W.; Niederberger, Craig S. et al. (2005). "Herniorrhaphy with Polypropylene Mesh Causing Inguinal Vasal Obstruction".Annals of Surgery 241 (4): 553–8.

13. Hallén, Magnus; Westerdahl, Johan; Nordin, Pär; Gunnarsson, Ulf; Sandblo, Gabriel (2012). "Mesh hernia repair and male infertility: A retrospective register study".Surgery 151 (1): 94–8. 

14. Fitzgibbons, Robert J. (2005). "Can We Be Sure Polypropylene Mesh Causes Infertility?". Annals of Surgery 241 (4): 559–61

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|9 |SIGNATURE OF THE CANDIDATE | |

| | | |

|10 |REMARKS OF THE GUIDE | |

| | | |

|11 |11.1 NAME AND DESIGNATION OF GUIDE |DR. R. SATISH KUMAR M.S |

| | |Professor of Surgery, |

| | |Kempegowda Institute of Medical Sciences and Research Centre, |

| | |Bengaluru-560004. |

| | | |

| |11.2 SIGNATURE | |

| | | |

| |11.3 HEAD OF THE DEPARTMENT |DR. K.G.SUDARSHAN BABU M.S |

| | |HOD & Professor of Surgery, |

| | |Kempegowda Institute of Medical Sciences and Research Centre, |

| | |Bengaluru-560004. |

| |11.4 REMARKS | |

| | | |

| |11.5 SIGNATURE | |

| | | |

|12 |12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL. | |

| | | |

| |12.2 SIGNATURE | |

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