Long - Term Low Anterior Resection Syndrome

NCT03920202 | Completed

• 1 other identifier: LongLARS
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Data assessing the long-term bowel dysfunction following low anterior resection is still lacking. The aim of this study is to evaluate late functional results of patients who underwent rectal resection for rectal cancer. This included calculating LARS and Wexner score and identifying possible risk factors of late postoperative bowel disorders.

Conditions

Bowel; Functional Syndrome

Keywords

Rectal cancer; Bowel dysfunction; Low anterior resection syndrome; Low anterior resection syndrome score; Quality of life

Outcome Measures

Primary Outcomes (1)

• Bowel function assessment using Low anterior resection syndrome questionnaire

  Bowel function following low anterior resection surgery for rectal cancer will be assessed using Low anterior resection syndrome score (LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).

  5 years

Secondary Outcomes (3)

• Risk factors: age

  5 years

• Risk factors: type of surgical procedure

  5 years

• Risk factors: preoperative chemoradiotherapy

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From 2007 through 2012, we identified a study population of 92 patients with biopsy proven, rectal cancer without distant metastasis located up to 15 cm from anal verge and undergoing low anterior resection with partial or total mesorectal excision. Preoperative staging was performed based on a digital rectal examination, chest and abdominal computer tomography scan (CT), pelvic magnetic resonance imaging (MRI) and colonoscopy with a biopsy.

You may qualify if:

• patients diagnosed with rectal cancer without metastasis
• signed consent form
• more than 5 years following the surgery

You may not qualify if:

• unwilling to participate
• stage IV disease
• change in operative plan - end colostomy formed

Sponsors & Collaborators

• National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos: lead

Study Sites (1)

National Cancer Institute

Vilnius, 08406, Lithuania

Location

Related Publications (1)

• Dulskas A, Kavaliauskas P, Pilipavicius L, Jodinskas M, Mikalonis M, Samalavicius NE. Long-term bowel dysfunction following low anterior resection. Sci Rep. 2020 Jul 17;10(1):11882. doi: 10.1038/s41598-020-68900-8.

  PMID: 32681140 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Rectal Neoplasms; Intestinal Diseases; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Narimantas Samapavicius, Prof.

  Klaipėda University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: April 18, 2019
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: December 31, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)