Long - Term Low Anterior Resection Syndrome
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03920202 Completed April 18, 2019 April 18, 2019

study description
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.

Condition or Disease: Bowel; Functional Syndrome
Intervention/treatment:
Phase: N/A
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 design
Study Type: Observational [Patient Registry]
Estimated Enrollment : 67 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
Official Title: Long - Term Bowel Dysfunction Following Low Anterior Resection
Actual Study Start Date: January 2012
Actual Primary Completion Date: January 2014
Actual Study Completion Date: December 2018
outcome measures
Primary Outcome Measures: 1. Bowel function assessment using Low anterior resection syndrome questionnaire [ Time Frame: 5 years ]
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).
Secondary Outcome Measures: 1. Risk factors: age [ Time Frame: 5 years ]
Risk factors for having worse bowel function following low anterior resection for rectal cancer - age: older patients (>55years) might have worse bowel function
2. Risk factors: type of surgical procedure [ Time Frame: 5 years ]
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.
3. Risk factors: preoperative chemoradiotherapy [ Time Frame: 5 years ]
Risk factors for having worse bowel function following low anterior resection for rectal cancer - preoperative chemoradiotherapy might lead to worse functional outcome.

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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


Contacts and Locations
Contacts
Locations
Lithuania National Cancer Institute Vilnius
Sponsors and Collaborators
National Cancer Institute, Lithuania
Investigator
Study Chair : Narimantas Samapavicius, Prof. KlaipÄ—da University
More Information
Responsible Party : National Cancer Institute, Lithuania
ClinicalTrials.gov Identifier : NCT03920202     
Other Study ID Numbers : LongLARS
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Last Verified : April 2019
Individual Participant
Data (IPD) Sharing
Statement:
 
Plan to Share IPD: No
Plan Description: Only results of the study will be shared
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute, Lithuania: Low anterior resection syndrome score
Rectal cancer
Bowel dysfunction
Low anterior resection syndrome
Quality of life
Additional relevant MeSH terms :
Irritable Bowel Syndrome
Syndrome