Incidence and Risk Factors of Low Anterior Resection Syndrome

Colorectal Cancer Clinical Trial

Official title:

Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06359730
• Other study ID #: 253/26-March-2024
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Low Anterior Resection Syndrome

Intervention

Other:
• LARS score questionnaire
LARS score questionnaire is filled by the patient after anterior resection for rectal cancer to study the quality of life

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	age	age of the patients in years was recorded from patient records	from 2017 to 2022
Primary	sex	sex of patients was recorded from patient records	from 2017 to 2022
Primary	medical disease	medical disease like diabetes and hypertension was recorded from patient records	from 2017 to 2022
Primary	site of tumor	tumor site was determined in Cm from anal verge by colonoscopy	from 2017 to 2022
Primary	neoadjuvant therapy	history of neoadjuvant therapy before surgery was obtained from patients records	from 2017 to 2022
Primary	site of anastmosis	site of anastmosis after resection was recorded as colo-rectal or colo-anal	from 2017 to 2022
Primary	type of meso-rectal excision	excision of meso-rectum was recorded if it was partial or complete	from 2017 to 2022
Primary	adjuvant therapy	it was recorded from patients records if he\she had chemo- or radiotherapy post-operatively	from 2017 to 2022
Primary	type of surgery	from records; surgery was open or laparoscopic	from 2017 to 2022
Primary	type of anastmosis	type of anastmosis(hand sewen or stappled) obtained from records	from 2017 to 2022
Primary	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