| CTRI Number |
CTRI/2024/03/064666 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparision between two treatment option in appendicitis |
|
Scientific Title of Study
|
STUDY ON THE CONSERVATIVE TREATMENT VERSUS OPERATIVE MANAGEMENT IN UNCOMPLICATED EARLY ACUTE APPENDICITIS |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sophiya pradhan |
| Designation |
Post graduate student general surgery department |
| Affiliation |
Government medical College Haldwani |
| Address |
Susheela tiwari government medical College & hospital, department of general surgery,unit 1, rampur road, Haldwani, nainital,india
Nainital
UTTARANCHAL
263139
India |
| Phone |
8755080375 |
| Fax |
|
| Email |
sophiyapradhan143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrProf Rajeev Kumar Singh |
| Designation |
professor and head of general surgery department |
| Affiliation |
Susheela tiwari medical College, Haldwani |
| Address |
Susheela tiwari government medical College and hospital, department of general surgery,unit-1, room no 17 , Haldwani, nainital
Nainital
UTTARANCHAL
263139
India |
| Phone |
9997484037 |
| Fax |
|
| Email |
headsurgery07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sophiya Pradhan |
| Designation |
Post graduate student general surgery department |
| Affiliation |
Susheela tiwari medical College,Haldwani |
| Address |
Susheela tiwari government medical College and hospital, general surgery department unit-1,room no 17 ,rampur road, Haldwani, nainital
Nainital
UTTARANCHAL
263139
India |
| Phone |
8755080375 |
| Fax |
|
| Email |
sophiyapradhan143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr sophiya pradhan ( self) department of general surgery , susheela tiwari hospital, Haldwani nainital pin code 263139, uttranchal, India |
|
|
Primary Sponsor
|
| Name |
Dr Sophiya pradhan |
| Address |
Department of general surgery susheela tiwari hospital,rampur road, Haldwani |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr professor Rajeev Kumar Singh |
Susheela tiwari government hospital |
Department of general surgery, general surgery ward,OPD no.17, rampur road, Haldwani, nainital
Nainital
UTTARANCHAL |
8755080375
sophiyapradhan143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical College, Haldwani Nainital ( uttarakhand) INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Medical management |
Other group of patients having early acute appendicitis will be managed conservatively via intravenous antibiotics for 7 days.
This intervention will be done for 1 year |
| Intervention |
Open appendicectomy |
One group of patients having early acute appendicitis will be treated via operative open appendicectomy .
This intervention will be done for 1 year |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients having uncomplicated early acute appendicitis presenting to surgery OPD and emergency |
|
| ExclusionCriteria |
| Details |
1) patients of generalized peritonitis, perforation,appendicular abscess, appendicular lump
2) patients with uncontrolled diabetes , hypertension
3) recurrent appendicitis
4) patients with suspected intraperitoneal malignancy
5) pregnant and lactating female
5) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All treated patients will be observed for complications after treatment received. |
All treated patients will be observed for complications after treatment received & followed up 3 Days,7 days,1 month after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)length of hospital stay
2) pain intensity before and after taking treatment
|
At time of presentation and 3 day ,7 days ,1 month after taking treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an interventional study in patients having uncomplicated early acute appendicitis . This is hospital based interventional study and will be conducted in general surgery department of susheela tiwari hospital. Subjects will be selected from patients presenting to surgery OPD and surgery emergency and surgery ward after giving informed consent . This will be single surgeon single unit study. The patients with in age group 5 years to 60 years will be included in this study and patients having complicated appendicitis ,co morbidity , lactating and pregnant female will be excluded from the study .
|