Long - Term Low Anterior Resection Syndrome

Bowel; Functional Syndrome Clinical Trial

— LongLARS  

Official title:

Long - Term Bowel Dysfunction Following Low Anterior Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920202
• Other study ID #: LongLARS
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: National Cancer Institute, Lithuania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 31, 2018
• Est. primary completion date: January 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel; Functional Syndrome
• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
Lithuania	National Cancer Institute	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Lithuania

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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