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
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 7, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedApril 11, 2024
April 1, 2024
5 years
April 7, 2024
April 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
age
age of the patients in years was recorded from patient records
from 2017 to 2022
sex
sex of patients was recorded from patient records
from 2017 to 2022
medical disease
medical disease like diabetes and hypertension was recorded from patient records
from 2017 to 2022
site of tumor
tumor site was determined in Cm from anal verge by colonoscopy
from 2017 to 2022
neoadjuvant therapy
history of neoadjuvant therapy before surgery was obtained from patients records
from 2017 to 2022
site of anastmosis
site of anastmosis after resection was recorded as colo-rectal or colo-anal
from 2017 to 2022
type of meso-rectal excision
excision of meso-rectum was recorded if it was partial or complete
from 2017 to 2022
adjuvant therapy
it was recorded from patients records if he\\she had chemo- or radiotherapy post-operatively
from 2017 to 2022
type of surgery
from records; surgery was open or laparoscopic
from 2017 to 2022
type of anastmosis
type of anastmosis(hand sewen or stappled) obtained from records
from 2017 to 2022
LARS score
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
Interventions
LARS score questionnaire is filled by the patient after anterior resection for rectal cancer to study the quality of life
Eligibility Criteria
patients who had anterior resection surgery for rectal carcinoma
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University Hospitals
Zagazig, 44519, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reham Zakaria, PhD
faculty of medicine Zagazig University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 7, 2024
First Posted
April 11, 2024
Study Start
December 1, 2017
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
April 11, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
IPD will be shared with other researchers on demand by e- mailing the principle investigator