| CTRI Number |
CTRI/2024/07/070488 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of quality of life in rectal cancer patients undergoing different types of surgery |
|
Scientific Title of Study
|
Assessment of quality of life in rectal cancer patients undergoing curative
surgery: Comparison between sphincter preservation and abdominoperineal
resection - An ambispective analytical cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gogul |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
5/192,Department of General surgery, Jawaharlal institute of postgraduate medical education and research
Erode
TAMIL NADU
638056
India |
| Phone |
8754383421 |
| Fax |
|
| Email |
krishgogul1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anandhi |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Room 1, 2nd floor, Department of General Surgery, Jawaharlal institute of postgraduate medical education and research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487781661 |
| Fax |
|
| Email |
anandhiramesh76@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Anandhi |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Room 1, 2nd Floor, Department of General Surgery, Jawaharlal institute of postgraduate medical education and research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487781661 |
| Fax |
|
| Email |
anandhiramesh76@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of General surgery, Jawaharlal institute of Postgraduate medical education and Research, Puducherry, India, 605006 |
|
|
Primary Sponsor
|
| Name |
GOGUL |
| Address |
Department of General surgery, Jawaharlal institute of Postgraduate medical education and Research, Puducherry, India, 605006 |
| 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 Gogul |
Jawaharlal institute of postgraduate medical education and research |
Department of general surgery Jawaharlal institute of postgraduate medical education and research
Pondicherry
PONDICHERRY |
8754383421
krishgogul1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies CDSCO Reg. No. ECR/342/Inst/PY/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients over 18 years of age with rectal cancer undergoing curative surgery such as
low anterior resection, intersphincteric resection and abdominoperineal resection |
|
| ExclusionCriteria |
| Details |
1. Surgery for perforated or bleeding rectal tumors done in emergency
2. Recurrent rectal cancer.
3. Rectal cancer other than adenocarcinoma.
4. Pregnant women.
5. Presence of other malignancy.
6. Patients with altered mental/cognitive status
7. Preexisting fecal incontinence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the quality of life in rectal cancer patients undergoing Abdominoperineal resection and sphincter preserving surgeries |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative morbidity
Low anterior resection syndrome |
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
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is an analytical cohort study comparing the quality of life of rectal cancer patients undergoing surgery. The primary outcome is to compare the quality of life of rectal carcinoma patients undergoing Abdomino perineal resection and sphincter preserving surgeries at the end of 1 year of surgery using EORTC C29, C30 and LARS questionnaire |