Long - Term Low Anterior Resection Syndrome (LongLARS)
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|ClinicalTrials.gov Identifier: NCT03920202|
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease|
|Bowel; Functional Syndrome|
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 [Patient Registry]|
|Actual Enrollment :||67 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Long - Term Bowel Dysfunction Following Low Anterior Resection|
|Actual Study Start Date :||January 1, 2012|
|Actual Primary Completion Date :||January 1, 2014|
|Actual Study Completion Date :||December 31, 2018|
- 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).
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920202
|National Cancer Institute|
|Vilnius, Lithuania, 08406|
|Study Chair:||Narimantas Samapavicius, Prof.||Klaipėda University|