RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE - II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

(To be submitted in duplicate)

1. Name and address of the : DR VIKAS.J.SINGH

Candidate A-2, SUVARNA KALASH

TARUN BHARAT SOCIETY,

CHAKALA, ANDHERI EAST,

MUMBAI 400099, MAHARASTRA

2. Name of the Institution : M S RAMIAH MEDICAL

COLLEGE AND TEACHING

HOSPITAL.

3. Course of study and : M.S. GENERAL SURGERY

Subject

4. Date of admission to course : 2nd May 2008

Date of commencement to course: 2nd May 2008

5. Title of the topic : A RANDOMIZED CONTROL TRIAL COMPARING THE EFFICACY OF TOTAL THYROIDECTOMY VS SUBTOTAL THYROIDECTOMY IN MANAGEMENT OF MULTINODULAR GOITRE

6. Brief resume of intended work.

6.1 Introduction and need for the study:

The choice between subtotal (ST) and total (TT) thyroidectomy for multinodular goiter

remains controversial despite numerous studies. The purpose of the study is to evaluate

the results of TT and ST in management of multinodular goiter (MNG) in our institution.

Since E.T. Kocher (1883) first demonstrated that TT caused

hypothyroidism (1) ,surgeons substituted a procedure of ST ,called partial thyroidectomy

at that time .In 1990, TT was performed in 4%of all benign thyroid diseases and in

7% in case of diffuse benign thyroid disease. In 1995, this incidence increased to 20%

and 37% respectively (8) whereas ST remained the procedure of choice in most cases. the

debate surrounding TT versus ST thus became widespread and international and it is still

in full swing.

Total Thyroidectomy is the procedure of choice in patients with thyroid

cancer, Basedow or Graves’s disease, and toxic multinodular goiter. In recent years, total thyroidectomy has emerged as a surgical option to treat patients with multinodular goiter, especially in endemic iodine deficient regions. Multinodular hyperplasia frequently involves the whole gland in endemic regions, and there is no normal tissue to leave behind. The rate of recurrence is high after subtotal resections for multinodular goiter in long-term follow-up, despite postoperative thyroid hormone supplementation. A considerable number of patients undergoing primary treatment with subtotal resection need reoperation for recurrence, which has a higher rate of complication compared with the primary procedures.

Although there has been increasing acceptance for performing total

thyroidectomy for MNG, surgeons still continue to debate whether the potential benefits outweigh the potential complications. There are still some who argue that total

thyroidectomy is an operation that is almost never justified. The use of total hyroidectomy for benign thyroid disease is therefore even more controversial, although

there are increasing numbers of reports recommending its use for bilateral benign multinodular goiter (BMNG).

6.2 Review of literature:

Discussion ST versus TT for management of benign thyroid disease is at least 30 yrs old

and it is alarming that in the year 2007 surgeons still had not reached consensus on the

matter. Indeed Samuel Perzik performed analytic review of about 1000 TT patients in

1976 (9, 10).That analysis revealed complications and sequelae comparable to those that

follow subtotal operations for nodular goiter.Perzik suggested that when surgery is

indicated for management of nodular goiter, nothing less than TT should be performed

because of the important additional advantage obtained with this operation.Ozbas et al

reported administration of L-thyroxine in all cases of partial and total thyroidectomies in

their study (11).therefore, no advantage in performing partial thyroidectomy with respect

to supplement hormone therapy was proven. the risk of recurrence after partial

thyroidectomy for MNG can be as high as 60 %( 12).The relatively high rate of

completion thyroidectomy and associated high rate of complications is an additional

argument supporting performing TT in MNG.Also ST leaves some room for malignant

transformation whereas TT does not. Some reports suggest that cancer will occur in22%

Of patients who initially had benign lesions (13).T.Colak et.al in his study (n=200)

showed that total thyroidectomy can be performed without increasing risk of

complication, and it is an acceptable alternative for benign multinodular goitre, especially

in endemic regions, where patients present with a huge multinodular goiter.Marchesi

et.al failed to demonstrate any 'hormonal advantage' in preserving thyroid tissue by

subtotal Thyroidectomy, and the low morbidity rate and no need for re-operation after

primary Total thyroidectomy; make the latter the procedure of choice for the management

of non-Toxic multinodular goiter. Leigh delbridge et.al in his study concluded that

Total Thyroidectomy is a safe and effective treatment for bilateral BMNG,. Its use has

corresponded to a reduction in the need for secondary thyroidectomy for recurrent goiter.

bilateral subtotal thyroidectomy was the principal procedure performed until 1984, when

total thyroidectomy became the preferred procedure. His unit now treats 94% of these

patients with total thyroidectomy. Secondary thyroidectomy for recurrent goiter initially

increased over the years (with a lag period of 13 years), reflecting the numbers of subtotal

procedures previously performed, and are now declining.

6.3 Objective of the study:

Aim of the study is to compare rates of post surgical complications following subtotal

and total thyroidectomy for multinodular goiter through a prospective cohort study

7. Materials and methods:

7.1 Source of data: Patients with multinodular goitre undergoing subtotal or total thyroidectomy at M.S Ramaiah teaching and memorial hospital, Bangalore between May 2008 to April 2010

7.2 Method of collection of data:

Informed consent will be taken for all tests and procedures included as part of study.

Fifty (50) patients with clinical suspicion of multinodular goitre would undergo routinely

thyroid function tests and FNAC of the suspicious nodule. All specimens will routinely

be examined histologically to confirm benign nature of the pathology and to exclude

malignancy. All patients will undergo routine serum calcium measurements and indirect

laryngoscopy. Then patients will be randomized into 2 groups,those undergoing total

thyroidectomy and those undergoing subtotal thyroidectomy. Demographic profiles,

biochemical findings, indications for operation, operating time, complications and

hospital stay will be noted. The surgical standards of TT and ST included resection of

both thyroid lobes while identifying the recurrent laryngeal nerve on both sides and

attempting to identify all parathyroid glands.TT technique followed the dissection when

the entire gland was removed from one tracheo oesophageal groove to another and ST

left no more than 25% of one lobe. Post operatively patient was assessed for presence of

following complications like recurrent laryngeal nerve (RLN) and superior laryngeal

nerve injuries (SLN), hypothyroidism , hypoparathyroidism, and recurrence of nodules.

Pre operative hypothyroidism is defined as baseline TSH level of > 5.5U/ml.Temporary

postoperative hypothyroidism is defined as serum TSH level >6.0mIU/l that persisted at

least 8 wks after surgery. All patients were discharged on L-thyroxine 100micrograms

daily. Patients will be followed up will be on OPD basis for at least 6months. However

during follow-up the dose of L-thyroxine will be adjusted according to individuals TSH

levels. Hypothyroidism was considered to be permanent when it persisted for 6months or

longer after surgery. Permanent post operative vocal cord palsy and permanent

hypoparathyroidism were determined whenever 6mths had elapsed after surgery.

Routine investigations

Complete blood count – Hb, TC, DC, BT, CT

Special Investigations

1) Thyroid function test

2) FNAC- fine needle aspiration cytology

3) Serum calcium

4) Indirect laryngoscopy

Inclusion criteria:

1) All patients undergoing thyroidectomy whose preoperative clinical diagnosis was

multinodular goitre.

1)

2) All patients with final pathologic process consistent with MNG

3) Patients who gave former consent for surgery

Exclusion criteria:

1) Previously known malignancy

2) Final pathologic process containing thyroid neoplasm requiring completion

thyroidectomy

3) Patients not giving former consent for surgery

Statistical analysis:

Statistical analysis will be done using appropriate parametric and non parametric tests.

Values of p ................
................

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