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SYNOPSIS
Rajiv Gandhi University of Health Sciences, Karnataka,
Bangalore.
EFFECT OF SINGLE PREOPERATIVE DOSE OF
SUBLINGUAL MISOPROSTOL ON INTRAOPERATIVE
BLOOD LOSS DURING TOTAL ABDOMINAL
HYSTERECTOMY
Name of the candidate :
DR. GANESH KUMAR K R
Guide
:
DR. PREMA D’CUNHA
Course and Subject
:
M.S (Obstetrics and Gynaecology)
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Father Muller Medical College,
Kankanady, Mangalore – 575002.
August – 2013
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1.
NAME OF THE CANDIDATE
DR. GANESH KUMAR K R
AND ADDRESS
POST GRADUATE RESIDENT
DEPT OF OBSTETRICS AND
GYNAECOLOGY
FATHER MULLER MEDICAL COLLEGE
KANKANADY
MANGALORE – 575002
2.
NAME OF THE
FATHER MULLER MEDICAL COLLEGE
INSTITUTION
KANKANADY
MANGALORE – 575002
3.
4.
COURSE OF STUDY AND
MS (OBSTETRICS AND
SUBJECT
GYNAECOLOGY)
DATE OF ADMISSION TO
31-05-2013
COURSE
5.
TITLE OF THE TOPIC:
EFFECT OF A SINGLE PREOPERATIVE DOSE OF
SUBLINGUAL MISOPROSTOL ON INTRAOPERATIVE BLOOD
LOSS DURING TOTAL ABDOMINAL HYSTERECTOMY
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BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Total abdominal hysterectomy is a common procedure for symptomatic
leiomyomas of the uterus. The chances of blood loss are more during intra-operative period
and in developing country like India, most women are anemic and it is necessary to reduce
intraoperative blood loss and postoperative blood transfusion.
The aim of the study is to check whether the pre-operative administration of
sublingual misoprostol, decreases blood loss during abdominal hysterectomy, thereby
decreasing the need of blood transfusion in post-operative period. Strong myometrial
contractions induced by misoprostol indirectly cause relative avascularity in the myoma
and may contribute reduction in bleeding.misoprostol when given sublingually attains
highest peak concentration compared to other routes of administration1.
There is paucicity of studies on effect of sublingual misoprostol on intraoperative
blood loss during abdominal hysterectomy. A study will therefore be conducted on the
patients with sympomatic leiomyomas of uterus in order to assess whether preoperative
dose of sublingual misoprostol can decrease
intraoperative blood loss during total
abdominal hysterectomy.
6.2 REVIEW OF LITERATURE:
Misoprostol, marketed in the USA since 1988 as a gastric cytoprotective drug. But
it has gained wide spread acceptance for cervical ripening and labour induction after
several randomized trial.
2
Misoprostol, a synthetic analog of prostaglandin E1, has been extensively evaluated as
an uterotonic agent in obstetrics mainly for prevention and management of postpartum
hemorrhage and reduction of bleeding during caesarean delivery. Among non-pregnant
women, misoprostol has been used for cervical priming before transcervical procedures ,
and for reducing blood loss in myomectomy and laparoscopy- assisted vaginal
hysterectomy1.
Recent studies have revealed that misoprostol when used preoperatively decreases
blood loss during total abdominal hysterectomy.1
Recently published pharmacokinetic studies show that sublingual and oral misoprostol
used for first trimester abortion, produces earlier and higher peak plasma concentration of
misoprostol than vaginal or rectal misoprostol. So the sublingual route could be expected to
be more effective than vaginal misoprostol2.
A study by Tang et,al., showed that sublingual route of administration of misoprostol
attains a quickest concentration compared to other routes of administration3.
6.3 OBJECTIVES OF STUDY:
a) To investigate whether use of preoperative misoprostol can reduce blood loss during
total abdominal hysterectomy
b) To find out the secondary outcome on the postoperative drop in haemoglobin and need
for blood transfusion
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7 MATERIAL AND METHODS
7.1 SOURCE OF THE DATA:
Patients with symptomatic uterine myomas admitted for total abdominal hysterectomy
with or without bilateral-salpingo oophorectomy in the department of OBG, Father Muller
Medical College and Hospital
7.2
DURATION OF STUDY: Two years
7.3 SAMPLE SIZE: 100 women with 50 women receiving sublingual misoprostol
400 microgram and 50 women do not receive any medication
7.4 STUDY TYPE: Single blind randomized controlled study
7.5 METHOD OF COLLECTION OF DATA
During the study period, women with symptomatic myomas will be initially counseled
about the available treatment options and those who opted for TAH with or without BSO
will be screened for eligibility. A few hours before the expected time of surgery, enrolled
women will be randomized to the study or control group via a lottery method. Those
randomized to the study group will receive a sachet containing 400 microgram of
misoprostol (2 tablets of 200 microgram), whereas those allocated to the control group will
not receive any drug. The ward sisters prepare the packets and open the allotted packets
and administered the tablets (misoprostol) sublingually 1 hour before the operation.
Baseline demographic data comprising age, parity, size of the uterus and preoperative
hemoglobin levels will be taken into consideration. All operations are conducted under
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spinal anesthesia. To avoid bias related to surgical skill, 4 consultant gynecologists, each
with more than 5 years of experience, perform all of the operations. The mop used for skin
and surface bleeding are discarded on opening the peritoneal cavity and excluded from this
calculation.
DATA IS ANALYSED BY :
(The contents of the suction container –amount of the wash given) + (The weight of the wet
mops - the weight of dry mop)+ weight of the clots. (where 1.06gm is equivalent to 1mL).
Postoperative hemoglobin levels are measured 24 hours after the operation. An automated
hemoglobin cyanide method will be used for hemoglobin measurement. Records will be
kept regarding blood transfusions and complications during the postoperative period.
Patients will be discharged on postoperative day 7 if permissible and asked to attend an
outpatient department for follow-up 6 weeks after the operation or earlier if required.
The primary outcome is to measure the hysterectomy-related blood loss during operation.
Secondary outcome measures will be the drop in hemoglobin level 24 hours after the
operation and the need of blood transfusion.
The outcomes will be assessed by:
1) In terms of blood loss during hysterectomy and
2) By hemoglobin levels 24hrs after surgery
3) Need for blood transfusion
7.6 PLAN FOR DATA ANALYSIS:– collected data will be analyzed by Mean, SD,
Student’s “t” test, Chi-square test, Mann-Whitney test
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7.7 INCLUSION CRITERIA:
Women with symptomatic myomas posted for total abdominal hysterectomy with
a. Age between 36-55years,
b. With size of uterus between 10-24wk,
c. Preoperative haemoglobin between 10-13gm%.
7.8 EXCLUSION CRITERIA:
•
Women with
heart disease, severe hypertension, haematological disorders,
glaucoma, bronchial asthma, liver disease, pelvic endometriosis, adnexal mass
•
women who had undergone previous myomectomy
•
women who received GnRH analogues
•
women who were allergic to prostaglandins
7.9
DOES
THE
STUDY
REQUIRE
ANY
INVESTIGATIONS
OR
INTERVENTIONS TO BE CONDUCTED ON PATIENT OR OTHER HUMAN OR
ANIMALS?
Yes
7.10
HAS
ETHICAL
CLEARANCE
INSTITUTION IN CASE
6
BEEN
OBTAINED
FROM
YOUR
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LIST OF REFERENCES:
1.
Biswas J, Chaudhuri P, Mandal A, Bandyopadhyay SN, Dasgupta S, Pal A. Effect of a
single preoperative dose of sublingual misoprostol on intraoperative blood loss during
total abdominal hysterectomy. Int J Gynaecol Obstet. 2013;122(3):
244-
7.Doi10.1016/j.ijgo.2013.03.025. Epub 2013 Jun 22.PubMed PMID:23800717.
2. Misoprostol pharmacokinetics profiles, effects on the uterus and side effects by O.S.
Tang,K. Gemzell- Danielsson and P.C.Ho, international journal of gynaecology and
obstetrics (2007)99 ,S160-S167
3. Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of
different
routes of administration of misoprostol. Hum Reprod. 2002;17(2):332-6. PubMed
PMID: 11821273.
4. Aronsson A., .Bygdeman B. and .Gemzell-Danielsson K. Department of Woman and
Child Health, Division for OBG, Karolinska Institute Hospital,S171,76 Stockholm,
Sweden, Human Reproduction Vol.19, No.1 pp. 81-84, 2004
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9.
SIGNATURE OF THE
CANDIDATE:
10.
REMARKS OF THE GUIDE:
11.
NAME AND DESIGNATION DR PREMA D’CUNHA
MS (OBG), DNB
OF THE
PROFESSOR
DEPARTMENT OF OBSTETRICS
11.1 GUIDE:
AND GYNAECOLOGY,
FATHERMULLER MEDICAL
COLLEGE
KANKANADY,
MANGALORE-575002
11.2 SIGNATURE :
11.3 CO-GUIDE:
11.4 SIGNATURE:
11.5 HEAD OF THE
DEPARTMENT:
11.6 SIGNATURE:
12.
12.1 REMARKS OF THE
CHAIRMAN & PRINCIPAL:
12.2 SIGNATURE;
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DR PREMA D’CUNHA
MS (OBG), DNB
PROFESSOR AND HOD,
DEPARTMENT OF OBSTETRICS
AND GYNAECOLOGY,
FATHERMULLER MEDICAL
COLLEGE
KANKANADY,
MANGALORE-575002
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