Ana səhifə

Proforma for registration of subject for dissertation


Yüklə 53.88 Kb.
tarix11.05.2016
ölçüsü53.88 Kb.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA,

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION



1.

Name of the Candidate and Address (in block letters)

Dr. DEEPAK RAMRAJ

S/o V. RAMRAJ

NO. 45, KALLAHALLI,

KENSINGTON ROAD,

BANGALORE – 560042.

KARNATAKA.



2.

Name of the Institution

J.J.M. MEDICAL COLLEGE,

DAVANGERE – 577 004, KARNATAKA.



3.

Course of study and subject

POSTGRADUATE

M.S. IN GENERAL SURGERY



4.

Date of Admission to Course

1st JUNE 2012

5.

Title of the Topic


A Prospective study of post operative complications and its management following hemorrhoidectomy”

6.

Brief resume of the intended work :

6.1 Need for the study :

Hemorrhoids are one of the commonest and oldest ailments to afflict mankind. References occur in ancient texts dating back to Babylonian, Egyptian, Greek, and the Hebrew cultures. Included in many of these writings are multiple recommended treatment regimes such as anal canal dilatation, topical ointments, and the intimidating red hot poker. Although few people have died of hemorrhoidal disease, many patients wished they had, particularly after therapy. In recent times many techniques carrying various eponyms have been described.

There are 2 basic varieties open and closed hemorrhoidectomy depending on whether or not the anorectal mucosa and perianal skin closed after the hemorrhoids have been excised and ligated. Options for hemorrhoidectomy include the techniques of Milligan-Morgan hemorrhoidectomy, closed Ferguson hemorrhoidectomy, Whitehead hemorrhoidectomy, and the stapled hemorrhoidectomy. The procedures are usually performed in the operating room after minimal preoperative preparation of the bowel. Lasers have no role to play in excisional hemorrhoidectomy, and in fact they cause delayed healing, increased pain, and increased cost. Surgical hemorrhoidectomy has a reputation for being a painful procedure for a fairly benign disease and is associated with various other complications. This prospective study is to evaluate the various post operative complications like post operative pain, Wound infections, Bleeding, Urinary retention, Anal incontinence, Anal stenosis, fissures and its management following hemorrhoidectomy.

6.2 Review of literature :

Hemorrhoids is derived from a Greek word meaning flow of blood (heam- blood rhoos- flowing). The word piles comes from latin pila meaning pill or a ball. There are few diseases that are more chronicled in human history than symptomatic hemorrhoidal disease.1,2 Hemorrhoids are a very common anorectal condition defined as the symptomatic enlargement and distal displacement of the normal anal cushions. They affect millions of people around the world, and represent a major medical and socioeconomic problem.3

Multiple factors have been claimed to be the etiologies of hemorrhoidal development, including constipation and prolonged straining. The abnormal dilatation and distortion of the vascular channel, together with destructive changes in the supporting connective tissue within the anal cushion, is a paramount finding of hemorrhoidal disease.2

It has been traditional to grade hemorrhoidal disease into four degrees depending on the extent of the prolapsed. After the hemorrhoids are appropriately staged, treatment options should be explored. Although this grading system has limitations, it is beneficial to determine the efficacy of various forms of treatment.4

In most instances, hemorrhoids are treated conservatively, using many methods such as lifestyle modification, fiber supplement, suppository-delivered anti-inflammatory drugs, and administration of venotonic drugs.5 Non-operative approaches include sclerotherapy and, preferably, rubber band ligation. An operation is indicated when non-operative approaches have failed or complications have occurred.

Several surgical approaches for treating hemorrhoids have been introduced including hemorrhoidectomy and stapled hemorrhoidopexy.

The Milligan-Morgan hemorrhoidectomy, was originally described in 1937, and its efficacy has been subsequently documented in many series.6,7 This technique includes resection of the entire enlarged internal hemorrhoid complex, ligation of the arterial pedicle, and preservation of the intervening anoderm.8 The distal anoderm and external skin is left open to minimize the risk of infection in the wounds. This technique is safe and effective. However, the fact that the external wounds are left open can be a cause of considerable discomfort and prolonged morbidity. The closed Ferguson hemorrhoidectomy was proposed as an alternative to the Milligan-Morgan technique and has a similar large body of reported experience.9,10,11

Regardless of the excisional technique used for the treatment of advanced hemorrhoidal disease, the key to effective patient management is avoiding postoperative complications.

Pain is the most frequent complication and the most feared sequela of the procedure from the patient's perspective. A variety of analgesic regimens have been recommended, usually consisting of a combination of oral and parenteral narcotics.12

Urinary retention is a frequent postoperative problem after hemorrhoidectomy, ranging in incidence from 1 to 52%.13,14 Jones and Schofield(1974) and Goligher (1984) reported that 8% of patients developed acute retention after Milligan Morgan technique .A variety of strategies have been used to treat the problem, including parasympathomimetics, alpha-adrenergic-blocking agents, and sitz baths. The best approach, however, seems to be prevention that includes limiting perioperative fluid administration to 250 ml, an anesthetic approach that avoids the use of spinal anesthesia, the avoidance of anal packing, and an aggressive oral analgesic regimen.15

Early postoperative bleeding (<24 hours) occurs in approximately 1% of patients and represents a technical error that requires return to the operating room for resuturing of the offending wound.16 Delayed hemorrhage occurs in 0.5 to 4% of cases of excisional hemorrhoidectomy at 5 to 10 days postoperatively.17 The cause is likely early separation of the ligated pedicle before adequate thrombosis in the feeding artery can occur. In this scenario, the bleeding is usually significant and requires some method for the control of ongoing hemorrhage. Options include return to the operating room for suture ligation or tamponade at the bedside with Foley catheter or anal packing.

Anal stenosis – provided adequate mucosal bridges are retained after excision ligation of hemorrhoids this complication should be rare. Jones and schofield 1974 found that 6 out 100 patients undergoing milligan morgan technique suffered from anal narrowing

Anal fissures is a rare complication which may result from a failure of the hemorrhoidectomy site to heal adequately Skin tags- edema in the perianal skin adjacent hemorrhoid wounds may result in skin tags. The incidence of skin tags is reported to occur in 4% of patients after excision ligation

6.3 Objectives of the study :


  1. Incidence of post operative complications following hemorrhoidectomy in CG hospital & Bapuji Hospital.

  2. To study the post operative complications: Post operative pain,Wound infections, Bleeding, Urinary retention ,Anal incontinence,Anal stenosis, fissures.

  3. To study the management of these complications.




7.

Material and methods :

7.1 Source of data :

The study will be conducted on the patients undergoing hemorrhoidectomy in CG hospital and Bapuji Hospital between november 2012 and September 2014.


7.2. Method of collection of data (including sampling procedure if any):

Inclusion Criteria


Exclusion Criteria

  • First degree haemorrhoids

  • Haemorrhoids with fissure in ano

  • Haemorrhoids with fistula n ano

  • Other ano rectal pathology

  • Other comorbid conditions such as portal hypertension, coronary artery disease , coagulation disorders


Method of collection of data

Study design : Prospective study

Sample size : Purposive sampling will be done and 50 patients will be selected who are fitting into my inclusion criteria
Study methods

The study consists of patients fitting under my inclusion criteria with written consent.

Patients will be administered the same antibiotics, analgesics during the hospital stay and postoperative period. All patients will be advised similar medications for softening of stools, wound dressings and all patients will receive sitz bath.

On discharge from the hospital, all patients will be on the similar antibiotics, analgesics, dietary and wound care advice.

The study group will be analysed post operatively on factors such as

1) Post operative pain :assessed by visual analogue scale

2) Bleeding

3) Wound infections

4) Urinary retention

5) Anal incontinence

6) Anal stenosis

7) Fissures


All patients will be assessed during the first post operative day, day of discharge, and at follow up visits at 1st week, 3rd week, 6th week, 12th week post operatively.


7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

YES.


  • Routine blood investigations, ECG, chest x-ray as required.

  • Surgery – haemorrhoidectomy

  • Surgical intervention for the complications that may occur

7.4. Has ethical clearance been obtained from your institution in case of 7.3?

Yes


Ethical clearance has been obtained from the Research and Dissertation Committee/ Ethical Committee of the institution for this study.

8.

List of References :

  1. Holley CJ. History of hemorrhoidal surgery. South. Med. J. 1946; 39:536.

  2. Madoff RD. Biblical management of anorectal disease. Presented at the Midwest Society of Colon and Rectal Surgeons meeting, March 1991, Breckenridge, CO.

  3. Varut LohsiriwatHemorrhoids: From basic pathophysiology to clinical management, World J Gastroenterol. 2012 May 7; 18(17): 2009–2017.

  4. Gordon PH, Nivatvongs S. Principles and Practice of Surgery for the Colon, Rectum, and Anus. 3rd ed. Informa Healthcare; 2007:Chapter 8.

  5. Acheson AG, Scholefield JH. Review Management of haemorrhoids;BMJ. 2008 Feb 16; 336(7640):380-3.

  6. Milligan ET, Morgan CN, Lond LE. Surgical anatomy of the anal canal, and the operative treatment of hemorrhoids. Lancet 1937; 2:1119.

  7. Duhamel J, Romand-Heuer Y. Technische Besonderheiten bei der Hämorrhoidektomie nach Milligan und Morgan. Coloproctology 1980; 4:265.

  8. Senagore A, Mazier WP., Luchtefeld MA, et al. The treatment of advanced hemorrhoidal disease: A prospective randomized comparison of cold scalpel vs. contact Nd:YAG laser. Dis. Colon Rectum 1993; 6:1042.

  9. Ferguson JA, Heaton JR. Closed hemorrhoidectomy. Dis. Colon Rectum 1959; 2:176.

  10. Muldoon JP. The completely closed hemorrhoidectomy: A reliable and trusted friend for 25 years. Dis. Colon Rectum 1981; 24:211.

  11. McConnell JC, Khubchandani IT. Long-term follow-up of closed hemorrhoidectomy. Dis. Colon Rectum 1983; 26:797.

  12. Kuo RJ. Epidural morphine for post-hemorrhoidectomy analgesia. Dis. Colon Rectum, Letter to the Editor 1995; 38:104.

  13. Hoff SD, Bailey HR, Butts DR, et al. Ambulatory surgical hemorrhoidectomy—A solution to postoperative urinary retention?. Dis. Colon Rectum 1994; 37:1242.

  14. Petros JG, Bradley TM. Factors influencing postoperative urinary retention in patients undergoing surgery for benign anorectal disease. Am. J. Surg. 1990; 159:374.




  1. Hoff SD, Bailey HR, Butts DR, et al. Ambulatory surgical hemorrhoidectomy—A solution to postoperative urinary retention?. Dis. Colon Rectum 1994; 37:1242.

  2. Corman ML. Complications of hemorrhoid and fissure surgery. In: Ferrari BT, Ray JE, Gathright JB, ed. Complications of Colon and Rectal Surgery—Prevention and Management, Philadelphia: W.B. Saunders; 1985:91-100.

  3. Milsom JW. Hemorrhoidal disease. In: Wexner SD, Beck DE, ed. Fundamentals of Anorectal Surgery, New York: McGraw-Hill; 1992:192-214.



9.

Signature of candidate


10

Remarks of the guide


Haemorrhoids a very common condition affecting mankind (one of the reason might be erect posture). Sometimes the condition will be confused with some other anal pathologies making the diagnosis difficult. So when it is treated by surgery and other methods, the complications are known to occur, so post haemorrhoidectomy complications should be identified promptly and treated appropriately to reduce the morbidity and sometimes mortality.


11

Name & Designation of (in block letters)

11.1 Guide

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of Department

11.6 Signature



Dr. B.V.C. JAGADEESH M.S.,

Professor

Department of GENERAL SURGERY,

J.J.M. Medical College,

DAVANGERE - 577 004.
- -

- -

Dr. R.L. CHANDRASHEKAR M.S.,

Professor and Head,

Department of GENERAL SURGERY,

J.J.M. Medical College,

DAVANGERE - 577 004.


12

12.1 Remarks of the

Chairman &

Principal


12.2. Signature.






Approval of Ethics Committee

To

Dr. DEEPAK RAMRAJ



Postgraduate,

DEPARTMENT OF GENERAL SURGERY,



J.J.M. Medical College, Davangere.
The Institutional Ethics Committee, J.J.M. Medical College, Davangere has reviewed and discussed your application to conduct the study/dissertation entitled
Title:

The following documents were reviewed :



  1. Trial Protocol (including protocol amendments), dated __________ Version no. (s). ___________ (not applicable).

  2. Patient information sheet and Informed Consent form (including updates if any) in English and/or vernacular language. (yes) in Vernacular language.

  3. Investigator’s Brochure, dated ______________, Version no. _________ (not applicable).

  4. Proposed methods for patient accrual including advertisement (s) etc. proposed to be used for the purpose. (not applicable)

  5. Principal Investigator’s current CV.

  6. Insurance Policy / Compensation for participation and for serious adverse events occurring during the study participation (not applicable)

  7. Investigators agreement with the sponsor. (not applicable)

  8. Investigators Undertaking (Appendix VII) (not applicable).

We approved the study to be conducted in its presented form.


The Institutional Ethics Committee, J.J.M. Medical College, Davangere expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/ informed consent and asks to be provided a copy of the final report.
Your’s sincerely,


Member Secretary, Ethics Committee

Chairman/Vice Chairman

Ethics Committee






Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©anasahife.org 2016
rəhbərliyinə müraciət