BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate & address / DR.VINAYAK CHAVAN
ROOM NO.305 PG MENS HOSTEL
HOSPITAL ROAD SHIVAJINAGAR,
BANGALORE - 560001
2 / Name of the institution / BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE-560002
3 / Course of study and subject / M.S. GENERAL SURGERY
4 / Date of admission to the course / 29-05-2012
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/ Title of topic / “COMPARATIVE STUDY OF HEALING BY PRIMARY CLOSURE VERSUS OPEN HEALING AFTER SURGERY FOR PILONIDAL SINUS ”
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8 / BRIEF RESUME OF INTENDED WORK:
6.1 Need for study:
Pilonidal sinus is a disease that most commonly arises in the hair follicles of the natal cleft of the sacrococcygeal area. Incidence is reportedly 26 per 1000 population, affecting males four times as often as females and predominantly young adults.1
Pilonidal sinus usually presents as an abscess or a chronically discharging, painful sinus tract. Irrespective of the mode of presentation the painful nature of the condition causes significant morbidity, often with a protracted loss of normal activity. 2
The management of chronic pilonidal disease is variable, contentious, and problematic. Principles of treatment require eradication of the sinus tract, complete healing of the overlying skin, and prevention of recurrence.3
For patients who have chronic or recurring pilonidal sinus disease, definitive operative management is warranted. Numerous procedures have been described in literature, ranging from simple incision and drainage to complex plastic flaps for cleft obliteration. Comparative studies in this field are rare. Most reports have been limited to single surgical approach with only few randomised controlled trials available in current literature.2
The present study compares the open technique with primary closure following excision, two of the most commonly performed methods, with healing time, rate of surgical site infection, time before return to work, morbidity rate, and recurrence rate and determine the most appropriate technique for the management of chronic pilonidal sinus disease.
6.2 Review of Literature:
Pilonidal disease consists of a hair-containing sinus or abscess that involves the skin and subcutaneous tissues in the postsacral intergluteal region. In 1833 Herbert Mayo described a hair-containing sinus but not until 1880 did Hodge suggest the term “pilonidal”, to indicate a disease consisting hair-containing sinus in the sacrococcygeal area.4
Originally thought to be a congenital condition, recent studies suggest that pilonidal sinus is an acquired disease that results from one or other of two aetiological mechanisms.
First, obstruction of the hair follicles can lead to follicle enlargement and rupture into the subcutaneous tissues causing abscess - and ultimately chronic sinus - formation. Secondly, broken hair can become inserted abnormally into the skin at the natal cleft, provoking a foreign-body reaction; the subsequent infection results in cyst formation or sinus disease.1
Patients with pilonidal sinus often present with an acute painful swelling in the natal cleft associated with an abscess with, or without, the drainage of bloody purulent material (pus) from the sinus opening. Alternatively, they may present with a chronically discharging, and often painful, sinus tract. Irrespective of the mode of presentation, the painful nature of the condition causes significant morbidity and, although many tolerate symptoms for up to one year before seeking treatment, there is often a protracted loss of normal activity for these patients.6
Many techniques have been advocated for the surgical treatment of chronic pilonidal disease. The spectrum of surgical methods ranges from simple drainage to various
sophisticated procedures such as Z-plasty, split-skin grafting, advancement flap rotation or Karydakis flap . Basically,these methods are classified into two main groups: total excision of the sinus, which is followed by either leaving the wound open (i.e., secondary healing) or its primary closure with techniques ranging from a simple suture to the numerous complex methods of flap rotations; and unroofing of the cavity without performing any excision followed by either leaving the wound open (i.e., lay-open) or suturing the skin edges to the lateral wall of the sinus (i.e.marsupialization).7, 8,
The entire pilonidal cyst is removed and the wound left to heal by secondary intention, typically requiring 8 to 21 weeks. Different studies have reported recurrence rates of 0-5%.6,7,8
Laying open of the track is associated with a low recurrence rate but slow healing.9
6.3 Objectives of study:
1. To compare open and closed surgical techniques in management of chronic pilonidal sinus disease.
2. To analyze, time for wound healing, surgical site infection, recurrence rate and other complications and morbidities.
MATERIALS AND METHODS:
7.1 Source of data:
Patients admitted in Bowring and Lady Curzon hospital and Victoria hospital attached to Bangalore Medical College and Research Institute from November 2012 to October 2014.
7.2 Methods of collection of data:
A. Study design: A Prospective study.
B. Study period: November 2012 to October 2014.
C. Sample size: It is a hospital based study of 40 cases, that is 20 cases healing by primary closure and 20 cases for secondary healing who fulfill the inclusion/exclusion criteria after informed consent.
D. Inclusion Criteria :
1. Patients willing to give written informed consent.
2. Adult patients (over 18 years of age) undergoing surgery for pilonidal sinus.
E. Exclusion Criteria:
1. Patients not willing to give informed consent.
2. Age less then 18yrs.
3. Patient presenting with conditions mimicking pilonidal sinus.
F. Methodology:
After obtaining the clearance from Institutional ethics committee, 40 patients fulfilling the inclusion/ exclusion criteria will be taken into the study, after obtaining written informed consent. Choice of type of procedure performed is, as per surgeon’s decision.
Data will be collected over a period of 24 months and compared and analysed for time for wound healing. Surgical site infection, reccurance rate ( after a follow up period of 6months) , complications and other morbidities.
H. Statistical analysis:
The data in this study will be analyzed by using ‘ANOVA’ test.
7.3 Does the study require any investigation to be conducted on patients or animals specify?
It does not require any animal studies.
Investigation required are: Routine investigations like Hb%, BT, CT and TC, DC, ESR, Urine routine, chest X-Ray, ECG, Sinogram
7.4 Has the ethical clearance been obtained from ethics committee of your Institution in case of 7.3?
Yes. Clearance has been obtained from the ethics committee of BMCRI, Bangalore
LIST OF REFERENCES :
1. Norman S Williams, Christopher J K, O’connell. ‘Bailey and Love’s short practice of Surgery’. 25th ed. (India: Hodder Arnold, 2008),p.1247-49.
2. Courtney M Townsend, Daniel Beauchamp, Mark Evers, Kenneth L Mattox. ‘Sabiston textbook of Surgery’. 19th ed. vol 2. (India: Elsevier, 2012),p. 1396-97.
3. Tufale A Dass, Muneer Raz, Azaj Rather. ‘Elliptical Excision with Midline Primary Closure Versus Rhomboid Excision with Limberg Flap Reconstruction in Sacrococcygeal Pilonidal Disease: A Prospective, Randomized Study’. Indian Journal of Surgery. August 2012. Vol.74. issue 4. p.305-306.
4. Seymour I. Schwartz. ‘Schwartz’s Principles of surgery’. 7th ed.(United States of America: The McGraw-Hill Companies, Inc.1999),p. 413.
5. Al-Khayat H, Al-Khayat H, Sadeq A et al (2007) ‘Risk factors for wound complication in pilonidal sinus procedures’. J Am Coll Surg. 205:439–444.
6. Sondenaa K, Andersen E, Nesvik I, Soreide JA. ‘Patient characteristics and symptoms in chronic pilonidal sinus disease’. Int J Colorectal Dis 1995;10:39-42.
7. McCallum I,King PM, Bruce J, AL-Khamis A. ‘Healing by primary versus secondary intention after surgical treatment for pilonidal sinus (Review)’.Cochrane Database Syst Rev..jan 2010;32(1):CD006213
8. Iain J D McCallum, Peter M King, Julie Bruce. ‘Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and meta-analysis’.bmj. april 2008; 336(7649)):868-71.
9. Parag Sahasrabudhe,Nikhil Panse, Chandrashekhar Waghmare. ‘V-Y Advancement Flap Technique in Resurfacing Postexcisional Defect in Cases with Pilonidal Sinus Disease—Study of 25 Cases’. Indian Journal of Surgery. October 2012,Volume74,Issue 5,p. 364-370.
9 / Signature of the candidate
10 / Remarks of the guide / This study helps to determine the wound healing time, infection rate and recurrance rate among the surgical procedures used in treatment of pilonidal sinus disease.
11.1 / Name and designation of the guide / Dr. Ravikar Jayraj
Assistant Professor
Department of General Surgery
BMCRI, Bangalore
11.2 / Signature of the guide
11.3 / Name and designation of co-guide
11.4 / Signature of the co-guide
11.5 / Head of the department / Dr. B S Shivaswamy
Professor and Head of the department
Department of General Surgery
BMCRI, Bangalore-560002
11.6 / Signature and seal of Head of the department
12.1 / Remarks of Dean cum Director
12.2 / Dean cum Director / DR O.S. Siddappa
Dean and Director
Bangalore Medical College and Research Institute,
Bangalore-560002
12.3 / Signature and seal
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