| CTRI Number |
CTRI/2023/06/054071 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Single vs double endoloop in Laparoscopic Appendicectomy |
|
Scientific Title of Study
|
A comparative analysis between the closure of appendicular stump with one endoloop and two endoloops in Laparoscopic Appendicectomy. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kornu Surya Pradeep Kumar |
| Designation |
Junior Resident, Department of General Surgery |
| Affiliation |
Kasturba hospital, manipal |
| Address |
3rd floor, Department of general Surgery ,Smt. Sharada Madhav pai, OPD building, Kasturba hospital,Manipal,Udupi,Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9052533633 |
| Fax |
|
| Email |
kornu.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jithin Abraham Jacob |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Medical Hospital, Manipal |
| Address |
3rd floor, Department of general Surgery ,Smt. Sharada Madhav pai, OPD building, Kasturba hospital,Manipal,Udupi,Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9632883146 |
| Fax |
|
| Email |
jithin.abraham@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jithin Abraham Jacob |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Medical Hospital, Manipal |
| Address |
3rd floor, Department of general Surgery ,Smt. Sharada Madhav pai, OPD building, Kasturba hospital,Manipal,Udupi,Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9632883146 |
| Fax |
|
| Email |
jithin.abraham@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
3rd floor,
Smt Sharada Madhav pai OPD building
Kasturba Hospital, Manipal, Udipi, Karnataka- 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, Manipal,Udipi,Karnataka- 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Kornu Surya Pradeep Kumar |
Kasturba Hospital, Manipal |
3rd floor, Department of general Surgery ,Smt. Sharada Madhav pai, OPD building, Kasturba hospital,Manipal,Udupi,Karnataka-576104
Udupi
KARNATAKA |
9052533633
kornu.kmcmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institute of Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18years.
Clinical diagnosis of appendicitis.
Cases completed by laparoscopic approach
All cases of Laparoscopic Appendectomy with normal Appendicular base.
|
|
| ExclusionCriteria |
| Details |
Age less than 18years old.
Patient on anticoagulant therapy.
Patient with known bleeding disorders.
Cases of abdominal TB and Inflammatory bowel diseases. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare & analyse the
1.Cost of treatment
2. Operative time
3.Hospital Stay
4.Post operative complications.
This study is an observational study & participation will not have any direct potential risk. |
Immediate post-op periods for one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hospital Stay
2.Post operative complications. |
30 days |
|
|
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)
|
25/06/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A comparative study between
single vs double endo-loop to appendicular stumps in Laparoscopic
Appendicectomy
The cases for the surgery will
be taken from Department of General surgery.
About 100 patients
are expected to participate in the study. By using the Chi
Square formula, and taking the Level of Significance as 0.05 and Power as 0.80
with Degrees of Freedom 1 , the sample size of of each case and control of the
sudy is 50 This sample size was acquired with the Chi-square formula. Patient are divided into study
group(single loop) and control group(double loop). The study group will be the
first 50 patients who belong to the inclusion criteria and the next 50 patients
fill in the control group. The cases for the study will be taken from the
Department of General Surgery. The diagnosed patients who are filling in the
inclusion criteria of the study are taken up in the sample. A data collection
proforma will be filled up by the prinicipal investigator. Immediate
post-operative complications will be monitored Routine clinical evaluation is done by the
principal investigator and reports shall be assessed as a part of the study.No
additional tests will be done during follow up. Study will go on for a duration
of 2 years. Patient diagnosed with Appendicitis and falling in the inclusion
criteria will be randomized into study group and control. Post operatively they
will assesses based on cost of treatment, operative treatment, time of stay and
post-operative complications and statistically analysed at the end of the study.Inclusion Criteria: Age more than
18years.Clinical diagnosis of appendicitis.Cases completed by laparoscopic
approach. All cases of Laparoscopic Appendectomy with normal Appendix. Exclusion Criteria: Age less than 18years
old. Patient on anticoagulant therapy. Patient with known bleeding disorders. Cases
of abdominal TB and Inflammatory bowel diseases. All patients with uncomplicated appendicitis are
considered for the study. Once the patient is evaluated planned and consented
for laparoscopic appendicectomy, patient will be provisionally included in the
study and taken consent for the same. Patient demographics and other details
will be interviewed and filled as per the proforma. The treating physician will
explain the use of endoloop for the procedure. Intra-operatively, if the
patient falls in the inclusion criteria, he/she will be recruited in the study
definitely and will be followed up for a period of one month. There is no added
risk to the participant as being a part of the study apart from those
associated with the standard Laparoscopic Appendectomy procedure. The patient may not get any benefit from participating in
this study. If the patient takes part in
this study it may help other patients to
have only to be able to put only one endoloop at the appendicular stump area. The
alternative treatment is the application of two endoloops at the appendicular
stump area. No Additional costs for participating in the study. All
tests done are part of standard of care and only reports are collected by the
researcher. Information from the study records
including your name, address, medical records, results of tests, study results
will be kept confidential and will be reviewed only by authorized personnel from
the sponsor or their representative, Ethics Committee or regulatory
bodies. The data will not be made
available to another individual unless you specifically give permission in
writing. Information and results from this study may be presented at meetings
or published in journals without including your name and personal
identifications. No reference will be made in oral or written reports which
could link you to the study |