Through proper channel
The Member Secretary-Ethics Subcommittee,
Ethics committee,
AIIMS,
New Delhi.
Sir/Madam,
Subject: Submission of protocol involving research in humans-for M.Ch dissertation
I am hereby submitting the protocol titled ‘A prospective study comparing Billroth II and Roux-en-y
gastrojejunostomy in patients with carcinoma stomach’ involving research in humans for
consideration by the ethics subcommittee and committee. This is part of the requirement for the degree of
M.Ch. (G.I. Surgery). The protocol has been signed by two faculty members and 14 copies of the protocol
and other necessary documents are enclosed.
Thanking you,
Yours faithfully,
Dr. Vishnu Prasad Ravella
Senior resident,
Dept of G I surgery,
AIIMS,
New Delhi.
1. Full Title of Study:
2.1 Name & signatures of the candidate
A prospective study comparing Billroth II and Rouxen-Y gastrojejunostomy in patients with carcinoma
stomach
2.1 Dr Vishnu Prasad Ravella
Signature
2.2 Department
2.2 GI Surgery and Liver Transplantation
2.3 Degree/course
2.3 M.Sc/MD/MS/MHA/M.Biotech/ MCh/DM/Ph.D
2.4 Batch of admission to course
2.4 July 2011
2.5 Month & year of submission of 2.5 Dec 2013
thesis
3. Name of Faculty & Department
Signatures (Guide/Co-Guides)
(Guide/Co-guide)
3.1 Dr. N R Dash (Guide)
3.1_____________________________________________
3.2 Prof. Peush Sahni
3.2 ____________________________________________
3.3 Dr. Sujoy Pal
3.3 ____________________________________________
3.4 Dr. Rakesh Kumar
3.4 ____________________________________________
4. Objectives of the study
The aim of this study is to compare Billroth II and Roux-enY reconstruction for gastric cancer in terms of postoperative
outcomes. These include postoperative gastrointestinal
symptoms, nutritional status and gastric emptying.
5. Why this study is required?
Please provide brief justification.
• Carcinoma of the stomach is one of the common cancers
6. Methodology
6.1. All patients with a diagnosis of carcinoma stomach
presenting to the department will be evaluated for inclusion
in the study.
6.2. Inclusion criteria
1 Age <75 years
2 Carcinoma stomach involving distal lesser curve,
distal greater curve, incisura and antrum.
3 Good performance status (Eastern Cooperative
Oncology Group [ECOG] grades 0, 1 and 2)
4 Contrast enhanced computerized tomographic
(CECT) scan suggesting a potentially resectable
lesion
6.3. Exclusion criteria
1 Patients who refuse consent
2 Comorbid conditions which would preclude
gastrectomy
3 Poor performance status (ECOG > 2)
American Society of Anesthesiologists class IV
4 Carcinoma involving proximal stomach /
gastroesophageal junction
5 Patients who have undergone previous gastrectomy
6 Patients with stomach cancer or previous small
bowel surgery precluding construction of either form
of anastomosis.
6.4. Control(s): Not applicable
6.5. Study design: Prospective study (Non randomized)
twenty patients will be included in each arm.
6.6. Dosages of drug: Not applicable as no new drug is
being administered or studied.
6.7. Not applicable
6.8. No additional investigations, other than those required
for standard treatment, will be required for the project.
6.9 Permission to use copyrighted Questionnaire/proforma:
WHO-QOL BREF: Permission taken, DAUGS 20
in Indian population. Distal/subtotal gastrectomy is
done for resectable distal gastric cancers,
postgastrectomy reconstruction or palliative bypass
is done with either Bilroth II or Roux-en-Y
gastrojejunostomy. Both techniques have their
merits and demerits and it is not clear whether one
of these methods provides superior outcomes in
patients with gastric cancer. Hence, this study is
planned to ascertain which of these methods
provides better outcomes in the short term in our
patients.
7. Permission from Drug Controller
General of India (DCGI)
8. Permission from DGFT , if required
Permission taken.
Not applicable
Not applicable
9. a) Safety measures for proposed The standard modalities of therapy will be used. These are
interventions
associated with morbidity and rarely mortality. No
additional/new modality of therapy is proposed to be used.
b) Results of relevant laboratory tests
b) Will be analyzed
c) Result of studies in human
c) Few studies have shown that Roux-en-Y reconstruction is
better in patients who have a partial gastrectomy for a
benign condition but to the best of my knowledge no study
has been done in patients with gastric cancer comparing
Roux-en-Y and Bilroth II reconstruction.
10. Plans to withdraw standard therapy
in research
Yes
X
No
11. Plan for provision of coverage for
medical risk
There is no additional risk from participation in the study.
12. How you will maintain
Confidentiality of subject?
All pertinent medical records would be treated as
confidential. However, the records may be reviewed and
inspected by AIIMS.
13. Costs Involved (Appx. in Rs.)
13. No additional costs will be involved
13.1 Investigations
13.2 Disposables
13.1. Gastric emptying study will be done in the 3 months
postoperative period in both the groups.
13.2 No additional disposables required
13.3 Implants
13.3 No implants are required
13.4 Drugs / Contrast Media
13.4 No drugs required
Who will bear the costs of the
requirements?
(mark √ )
1. Patient 2. Project 3.
Exempted
4.
Other Agencies: AIIMS provides free treatment to
patients. As for patients undergoing standard treatment,
patients included in the study will need to spend on the
items that AIIMS does not provide
Attached English version
14. Participant Information Sheet
(mark √ if yes)
Attached Hindi version
Certified that Hindi version is a true translation of
English version
15. Participant Informed Consent Form
(mark √ if yes)
Attached English version
Attached Hindi versiom
Certified that Hindi version is a true translation of English
version
16. Whether any work on this project
has started or not?
17.Attached documents
(If any)
no
17.1 Covering letter, through proper channel.
17.2 Copy of the detailed protocol is mandatory
17.3 Undertaking that the study shall be done in accordance
with ICMR and GCP guidelines
17.4 In case of multicentric study, IEC clearance of other
centres must be provided
17.5 Definite undertaking as to who will bear the
expenditure of injury related to the project
17.6 In case an insurance cover is intended, Insurance
certificate must be provided (as per ICMR guidelines)
17.7 : Permission as mentioned in 6.9
17.8: Certificate/undertaking as mentioned in 16
17.9 Others:
Through proper channel
The Member Secretary-Ethics Subcommittee,
Ethics committee,
AIIMS,
New Delhi.
Sir/Madam,
Subject: Submission of corrected protocol involving research in humans-for M.Ch dissertation
In reference to the remarks of the Ethics committee (Ref no. IESC/T-285/29.06.2012). I am
hereby submitting the corrected protocol titled ‘A prospective study comparing Billroth II and Rouxen-y gastrojejunostomy in patients with carcinoma stomach’. The following changes were made in
accordance with the remarks of the Ethics sub-committee. 1) Permission was taken to use DAUGS 20 and
WHO QOL BREF scoring systems, 2) Number of patients going to be included in each arm is mentioned,
3) The study will be non-randomized prospective study, 4) The complications have been mentioned in the
English and Hindi version of PIS.
Thanking you,
Yours faithfully,
Dr. Vishnu Prasad Ravella
Senior resident,
Dept of G I surgery,
AIIMS,
New Delhi.