Long - Term Low Anterior Resection Syndrome (LongLARS)

Long - Term Bowel Dysfunction Following Low Anterior Resection

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.

Study Overview

• Status: Completed
• Conditions: Bowel; Functional Syndrome

Detailed Description

For the last almost 30 years, the gold standard treatment for RC is low anterior resection (LAR) with total mesorectal excision (TME). Unfortunately, up to 80 % of patients undergoing LAR will suffer of bowel dysfunction including faecal urgency, frequent bowel movements, tenesmus or so called Low Anterior Resection Syndrome (LARS). Simply it has been defined as "disordered bowel function after rectal resection, leading to a detriment in quality of life". Same year LARS score was developed. This tool is easy to use and has been internationally and in Lithuania validated. Wexner score is another tool for evaluation of faecal continence.

There are only five studies investigating long-term results after rectal surgery and influence it has on patients' daily life. In one study 47 of 51 patients experienced LARS following ultra-low anterior resection after average 6.5 years. Another study recently reported major LARS in 46% of the patients with the mean median follow-up of 14.6 years. Others showed that 47.5% of patients still experience LARS symptoms at a follow-up period of 13.7 years. Just recently published study assessed bowel function 12 years in patients undergoing rectal resection with or without preventing ileostomy. Authors found that 63 (72%) patients of 87 experienced LARS symptoms with more than a half complaining of major LARS. Moreover, just last year a study published showing that 73% of patients had LARS at first follow up 5 years after the surgery. During the second visit (another 5 years later) same numbers were seen.

The aim of this study was 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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08406
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors: age	Risk factors for having worse bowel function following low anterior resection for rectal cancer - age: older patients (>55years) might have worse bowel function	5 years
Risk factors: type of surgical procedure	Risk factors for having worse bowel function following low anterior resection for rectal cancer - type of surgery: rectum resection with total mesorectal excision vs partial mesorectal excision will lead to worse functional outcome.	5 years
Risk factors: preoperative chemoradiotherapy	Risk factors for having worse bowel function following low anterior resection for rectal cancer - preoperative chemoradiotherapy might lead to worse functional outcome.	5 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Lithuania
• Investigators: Study Chair: Narimantas Samapavicius, Prof., Klaipėda university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Low anterior resection syndrome; Quality of life; Rectal cancer; Bowel dysfunction; Low anterior resection syndrome score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: LongLARS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only results of the study will be shared

Drug and device information, study documents

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