| CTRI Number |
CTRI/2020/04/024819 [Registered on: 23/04/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of the changes in bowel movements after surgery for rectal cancer and how it affects the quality of life of such patients. |
|
Scientific Title of Study
|
Low anterior resection syndrome in patients undergoing sphincter preservation surgery for rectal cancers, factors affecting it and change in quality of life over time |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandramohan K |
| Designation |
Additional Professor, Dept. of Surgical Oncology |
| Affiliation |
Regional Cancer Centre |
| Address |
Additional professor
Dept. of Surgical Oncology
Regional Cancer Centre
Thiruvananthapuram
Kerala
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
drchandramohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandramohan K |
| Designation |
Additional professor, Dept. of Surgical Oncology |
| Affiliation |
Regional Cancer Centre |
| Address |
Additional professor
Dept. of Surgical Oncology
Regional Cancer Centre
Thiruvananthapuram
Kerala
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
drchandramohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandramohan K |
| Designation |
Additional Professor, Dept. of Surgical Oncology |
| Affiliation |
Regional Cancer Centre |
| Address |
Additional professor
Dept. of Surgical Oncology
Regional Cancer Centre
Thiruvananthapuram
Kerala
Thiruvananthapuram
Kerala
India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
drchandramohan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Regional Cancer Centre |
| Address |
Medical College Campus
Thiruvananthapuram
Kerala, India |
| 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 Chandramohan K |
Regional Cancer Centre |
Medical College Campus
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA |
9895774393
drchandramohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HumanEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K599||Functional intestinal disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LARS score |
All patients who undergo had undergone low anterior resection for rectal cancer in Regional Cancer, one year before will be interviewed by a trained interviewer twice at 3-6 months interval using Wexner Incontinence Score 2.LARS Malayalam Questionnaire
3.EORTC QLQ C30 and CR 29 Malayalam translations for measuring QOL. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing low anterior resection in Regional Cancer centre, Trivandrum at least one year before the recruitment date and who voluntarily give informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. History of any pelvic surgery for malignancy in the past
2. History of radiation to pelvis for reasons other than neo adjuvant radiation for rectal cancer at present
3. Recurrent cancers
4. Presence of inflammatory bowel disease
5. Presence of irritable bowel syndrome
6. History of surgery for hemorrhoids, fissure or anal fistula
7. History of pelvic inflammatory disease
8. History of pelvic peritonitis in the past
9. History of Pelvic floor disease or incontinence of neuro muscular origin. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of LARS syndrome in patients undergoing low anterior resection for rectal cancer. |
Post surgery, 3 months and 6 months post op. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors affecting the causation of low anterior resection syndrome and changes in QoL in these patients. |
Post surgery, 3 months and 6 months post op. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
27/04/2020 |
| 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)
|
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)?
|
|
Brief Summary
|
For most surgeons and
patients , rectal cancer sphincter preservation is of paramount importance , whenever
oncologically feasible. Surgeons seek extra
pride in putting efforts for sphincter preservation even in a very low
rectal cancer. The oncologic outcome is same as the Abdominoperineal resection,
the surgery resulting in extirpation of sphincter function .But in reality up to 70% patients, after
sphincter saving surgery for rectal cancer have significant bowel dysfunction
affecting their quality of life(1-3).This is called Low Anterior Resection Syndrome (LARS).The
symptoms of the LARS are multiple or frequent defecations, incomplete bowel
movements, repetitive defecatory attempts resulting in passage of small amounts
of stool within a few hours(clustering),fecal incontinence( disorders ranging
from minimal soiling or flatus incontinence to major incontinence of liquid and
/or solid stools, urgency (that is the impossibility of retaining fecal emission
more than 15 minutes after the sensation). We intend to study the incidence of LARS in our patients and also the factors affecting the causation of such symptoms after surgery. |