| CTRI Number |
CTRI/2025/04/084012 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identify the outcomes of different levels of below knee amputations among patients admitted in sir t hospital |
|
Scientific Title of Study
|
A Prospective Observational Study On Outcomes Of different levels Of Below knee amputations among patients admitted in sir t hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavsar Parthiv Pradipbhai |
| Designation |
Resident doctor |
| Affiliation |
Government medical college bhavnagar |
| Address |
Room no 66 department of general surgery sir t hospital bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9979025569 |
| Fax |
|
| Email |
parthiv.bhavsar447@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Firdaus a dekhaiya |
| Designation |
Associate professor |
| Affiliation |
Government medical college bhavnagar |
| Address |
Department of general surgery Sir t hospital bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825133976 |
| Fax |
|
| Email |
drfirdausd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Firdaus a dekhaiya |
| Designation |
Associate professor |
| Affiliation |
Government medical college bhavnagar |
| Address |
Department of general surgery Sir t hospital bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825133976 |
| Fax |
|
| Email |
drfirdausd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and sir t hospital Bhavnagar-364001 |
|
|
Primary Sponsor
|
| Name |
Government medical college bhavangar |
| Address |
near ST bus stand jail road kalanala bhavnagar gujarat-364001 |
| 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 Parthiv Bhavsar |
Sir T hospital |
Department of general surgery,
Government medical college
Bhavnagar
Bhavnagar
GUJARAT |
09979025569
parthiv.bhavsar447@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee government medical college Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the patients undergoing lower limb amputation on different levels below the knee at Department of surgery Sir T Hospital Bhavnagar |
|
| ExclusionCriteria |
| Details |
No absolute exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the peri-operative and post-operative outcomes of various levels of lower limb amputations below the knee joint. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any association of different co-morbidities with the amputations. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Lower limb amputation (LLA) is life-changing surgery. Shorter residual limbs are known to impose great physiological and psychological strain on patients. The aetiology of amputation is a major factor in deciding its level of amputation. There are multiple factors that lead to the inevitable ultimate intervention to remove the limbs; Infective,Malignancy, Arterial insufficiency,Venous insufficiency and Trauma. In a majority of cases ,multifactorial diseases like Diabetes Mellitus lead to amputation . In this study we are going to compare various peri- and post- operative outcomes associated with different levels of lower limb amputations below the knee joint which includes post operative wound complications ,patient compliance,revision surgery,recovery rate,hospital stay,economic burden, rehabilitation opportunities and overall morbidity. |