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: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: LARS score questionnaire

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Zagazig University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients who had anterior resection surgery for rectal carcinoma

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Reham Zakaria, PhD, Faculty of Medicine Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rectal cancer; LARS; anterior resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Low Anterior Resection Syndrome
• Other Study ID Numbers: 253/26-March-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared with other researchers on demand by e- mailing the principle investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No