- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359730
Incidence and Risk Factors of Low Anterior Resection Syndrome
Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients
Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.
With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Zagazig, Egypt, 44519
- Zagazig University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age more than 18
- Diagnosed patients with rectal adenocarcinoma and who received low anterior resection with anastomosis creation or after a minimum 6 months interval after stoma reversal.
- Tumors of the rectum (2-15 cm) from anal verge
Exclusion Criteria:
• cognitive dysfunction
- Having a history of inflammatory bowel disease or any disease with bowel function impairment namely, Crohn's disease, irritable bowel syndrome, ulcerative colitis or others.
- Age less than 18
- Metastatic cancer or tumor recurrence
- Rectal tumors within 2 cm from anal verge( abdominoperineal)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
age
Time Frame: from 2017 to 2022
|
age of the patients in years was recorded from patient records
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from 2017 to 2022
|
sex
Time Frame: from 2017 to 2022
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sex of patients was recorded from patient records
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from 2017 to 2022
|
medical disease
Time Frame: from 2017 to 2022
|
medical disease like diabetes and hypertension was recorded from patient records
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from 2017 to 2022
|
site of tumor
Time Frame: from 2017 to 2022
|
tumor site was determined in Cm from anal verge by colonoscopy
|
from 2017 to 2022
|
neoadjuvant therapy
Time Frame: from 2017 to 2022
|
history of neoadjuvant therapy before surgery was obtained from patients records
|
from 2017 to 2022
|
site of anastmosis
Time Frame: from 2017 to 2022
|
site of anastmosis after resection was recorded as colo-rectal or colo-anal
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from 2017 to 2022
|
type of meso-rectal excision
Time Frame: from 2017 to 2022
|
excision of meso-rectum was recorded if it was partial or complete
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from 2017 to 2022
|
adjuvant therapy
Time Frame: from 2017 to 2022
|
it was recorded from patients records if he\she had chemo- or radiotherapy post-operatively
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from 2017 to 2022
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type of surgery
Time Frame: from 2017 to 2022
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from records; surgery was open or laparoscopic
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from 2017 to 2022
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type of anastmosis
Time Frame: from 2017 to 2022
|
type of anastmosis(hand sewen or stappled) obtained from records
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from 2017 to 2022
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LARS score
Time Frame: from 2017 to 2022
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obtained by LARS questionnaire filled by the patient during follow up, it was formed of five questions with different scores on answer choices, interpretaion (0-20) means no LARS, (21- 29) means minor LARS, (30-42) means major LARS
|
from 2017 to 2022
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reham Zakaria, PhD, faculty of medicine Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 253/26-March-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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