Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

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.
J.J.M. MEDICAL COLLEGE,
NAME OF THE INSTITUTION
DAVANGERE – 577 004, KARNATAKA.
COURSE OF STUDY AND
SUBJECT
POSTGRADUATE
4.
DATE OF ADMISSION TO
COURSE
1 st 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 :
3.
M.S. IN GENERAL SURGERY
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
1
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 (heamblood 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
2
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 devel oped
acute retention after Milligan Morgan technique .A variety of strategies have been
used to treat the problem, including parasympathomimetics, alpha -adrenergicblocking 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
3
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 failur e 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.
4
7.2. Method of collection of data (including sampling procedure if any):
Inclusion Criteria

Third and Fourth degree haemorrhoids

Failure of conservative treatment of second degree haemorrhoids
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
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.
6
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.
7
15. Hoff
SD,
Bailey
HR,
Butts
DR,
et
al.
Ambulatory
surgical
hemorrhoidectomy—A solution to postoperative urinary retention?. Dis.
Colon Rectum 1994; 37:1242.
16. 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.
17. Milsom JW. Hemorrhoidal disease.
In: Wexner SD, Beck DE, ed.
Fundamentals of Anorectal Surgery, New York: McGraw-Hill; 1992:192214.
8
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
Dr. B.V.C. JAGADEESH M.S.,
PROFESSOR
DEPARTMENT OF GENERAL SURGERY,
J.J.M. MEDICAL COLLEGE,
DAVANGERE - 577 004.
11.2 Signature
11.3 Co-Guide (if any)
--
11.4 Signature
--
11.5 Head of Department
Dr. R.L. CHANDRASHEKAR M.S.,
PROFESSOR AND HEAD,
DEPARTMENT OF GENERAL SURGERY,
J.J.M. MEDICAL COLLEGE,
DAVANGERE - 577 004.
11.6 Signature
12
12.1 Remarks of the
Chairman &
Principal
12.2. Signature.
9
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 :
a. Trial Protocol (including protocol amendments), dated __________ Version no.
(s). ___________ (not applicable).
b. Patient information sheet and Informed Consent form (including updates if any)
in English and/or vernacular language. (yes) in Vernacular language.
c. Investigator’s Brochure, dated ______________, Version no. _________ (not
applicable).
d. Proposed methods for patient accrual including advertisement (s) etc. proposed
to be used for the purpose. (not applicable)
e. Principal Investigator’s current CV.
f. Insurance Policy / Compensation for participation and for serious adverse
events occurring during the study participation (not applicable)
g. Investigators agreement with the sponsor. (not applicable)
h. 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/ inform ed consent and asks
to be provided a copy of the final report.
Your’s sincerely,
Member Secretary, Ethics Committee
Chairman/Vice Chairman
Ethics Committee