| CTRI Number |
CTRI/2025/08/093492 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate quality of life (QOL) in patients diagnosed with cancer stituated deep inside abdominal cavity and who underwent complex surgeries involving multiple abdominal organs and blood vessels. |
|
Scientific Title of Study
|
To evaluate quality of life (QOL) in patients undergoing multivisceral resections and/or vascular resections for retroperitoneal sarcomas. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No 4725 V2.0 Dated 19 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Cheif Hepatobilliary Surgeon |
| Affiliation |
Tata Memorial Hospital, Mumbai-12 |
| Address |
OPD no 324, Gastro-Intestinal Disease management Group, 3rd FLoor, Homi Bhabha Building, Dr E Borges Road, Parel,
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Cheif Hepatobilliary Surgeon |
| Affiliation |
Tata Memorial Hospital, Mumbai-12 |
| Address |
OPD no 324, Gastro-Intestinal Disease management Group, 3rd FLoor, Homi Bhabha Building, Dr E Borges Road, Parel,
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhila Mamidigi |
| Designation |
SENIOR RESIDENT II |
| Affiliation |
Tata Memorial Hospital, Mumbai-12 |
| Address |
OPD no 324, Gastro-Intestinal Disease management Group, 3rd FLoor, Homi Bhabha Building, Dr E Borges Road, Parel,
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224174266 |
| Fax |
|
| Email |
sheethalakhila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai, Maharashtra, India 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital, Mumbai |
| Address |
Dr E Borges Road, Parel, Mumbai, Maharashtra, India 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mahesh Goel |
Tata Memorial Hospital |
OPD no 324, Gastro-Intestinal Disease Manaegment Group, Department of Surgical Oncology,3rd Floor, Homi Bhabha Building, Dr E Borges Road, Parel,
Mumbai
MAHARASHTRA |
9820504492
drmaheshgoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C480||Malignant neoplasm of retroperitoneum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients who can be contacted in person or telephonically
2. All patients over 18-years of age, undergoing Multi-visceral resections for RP sarcomas
3. All patients undergoing Vascular resection (with/ without reconstructions) for RP sarcomas
|
|
| ExclusionCriteria |
| Details |
1.Other RP tumors (non-sarcomas)
2.Patients not willing to participate in the study/ cannot give a valid informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Long-term ( more than 8 weeks) QOL in patients undergoing multivisceral and/or vascular resections for RP sarcomas |
day 0 on the day of enrollment, 3 months and 6 months after enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate short-term outcomes (less than 8 weeks) as Post op morbidity, Post-op Ileus, Acute renal failure, Diarrhoea, Clinically significant chyle leaks, Limb weakness, Lower limb edema , Length of ICU stay, ICU re-admission rates, Length of hospital stay, Hospital readmission rates, Re-operation rates, Fitness for adjuvant chemo |
day 0 on the day of enrollment, 3 months and 6 months after enrollment |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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 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
|
Type of study: Retrospective
and Prospective study
This study aims to evaluate the quality of
life (QOL) in patients undergoing multivisceral resections and/or vascular
resections for retroperitoneal sarcomas. Retroperitoneal sarcomas are rare
tumors that develop in the space behind abdominal organs and can grow to
substantial sizes before causing symptoms. Due to their proximity to critical organs
and blood vessels, surgical removal often requires extensive procedures
involving multiple organs or blood vessel reconstruction. While surgery is
essential for improving survival, it can lead to complications that
significantly impact the physical, emotional, and social well-being of
patients.
The study will assess both short-term and
long-term outcomes, including post-operative complications such as kidney
issues, bowel dysfunction, pain, weakness, and hospital readmissions. In the
longer term, it will evaluate changes in renal function, nutritional status,
limb strength, and the need for prolonged medication. Quality of life will be
measured using the widely recognized EORTC QLQ-C30 questionnaire, which
evaluates physical, emotional, and social functioning alongside symptoms
experienced by patients after cancer treatment. Researchers will collect data
retrospectively from January 2016 to January 2025 and prospectively until June
2026, covering a total of 200 patients.
The ethical aspects of this research will
be carefully managed, with informed consent obtained from participants in a
language they understand. Confidentiality and data privacy will be strictly
maintained. Institutional ethics committee approval will be sought, and adverse
events will be reported according to regulatory guidelines. The study will
adhere to international and institutional standards for patient safety and
research integrity.
By identifying key factors influencing
recovery and quality of life, this research is expected to guide better
clinical decision-making for patients undergoing complex surgeries for
retroperitoneal sarcomas. The development of a sarcoma-specific QOL scoring
system may help healthcare providers improve treatment strategies and patient
support in both short- and long-term settings. |