| CTRI Number |
CTRI/2021/11/038241 [Registered on: 24/11/2021] Trial Registered Prospectively |
| Last Modified On: |
29/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective study of faster recovery protocol for bone and soft tissue cancer surgeries |
|
Scientific Title of Study
|
A prospective observational study to assess the compliance to enhanced recovery protocols among patients undergoing bone and soft tissue cancer surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sohan Lal Solanki |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177053 |
| Fax |
|
| Email |
me_sohans@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Apte |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07972729182 |
| Fax |
|
| Email |
drsagarapte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Apte |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07972729182 |
| Fax |
|
| Email |
drsagarapte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai-400012, India |
|
|
Primary Sponsor
|
| Name |
Dr Sohan Lal Solanki |
| Address |
Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai |
| 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 Sohan Lal Solanki |
TATA MEMORIAL HOSPITAL |
Room No 210, Second Floor, OT Complex, Department of Anaesthesia, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA |
02224177053
me_sohans@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional Ethics Committee-II Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C419||Malignant neoplasm of bone and articular cartilage, unspecified, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1-3
2. Patients planned for curative surgeries of bone and soft tissue tumour (benign or malignant) of upper limb, lower limb, spine and pelvis (with or without neo-adjuvant chemotherapy)
|
|
| ExclusionCriteria |
| Details |
1. Undergoing emergency surgery.
2. Patients in which surgery is abandoned because of inoperability.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage compliance with individual components of the bone and soft tissue enhanced recovery pathway. |
Time of first hospital visit to discharge from hospital after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Average compliance of patients with the components of the bone and soft tissue enhanced recovery pathway.
2. Post-operative complications between patients with different levels of compliance with the bone and soft tissue enhanced recovery pathway. |
Time of first hospital visit to discharge from hospital after surgery and 30-day mortality. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/12/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ERAS
(Enhanced recovery after the surgery) society has provided multimodal approach
for perioperative care of patients to improve postoperative outcome. The aim of implementation
of ERAS protocol is to reduce the surgical stress, maintain normal physiology
to expedite the recovery. ERAS protocols have been developed in various orthopaedic
and spine surgeries including bone and spine tumours. It has proven
beneficial in terms of mortalities, morbidities and length of hospital stay.
Bone
and soft tissue tumours are of various types and occurs in both adults and
children. Orthopaedic oncosurgeries involves benign, malignant and metastatic
bone tumours and soft tissue tumours. Recent surgical
management for musculoskeletal tumours focuses more on function preservation
and overall quality of life. Surgical
management involves significant blood loss, functional impairment. Adjuvant
chemotherapy causes various systemic complications which adds to further
morbidity and mortality. Application of
ERAS protocol has been studied in spinal tumours and soft tissue sarcomas, but
evidence in bone tumours and soft tissue sarcoma is scarce.
The
aim of our study is to conduct a prospective observational study to determine
the compliance to enhanced recovery pathway in patients undergoing surgeries
for musculoskeletal tumours at our tertiary care cancer centre. |