Clinical trial NCT03920202: Long - Term Low Anterior Resection Syndrome
Official title: Long - Term Bowel Dysfunction Following Low Anterior Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel; Functional Syndrome
Keywords: Rectal cancer
Bowel dysfunction
Low anterior resection syndrome
Low anterior resection syndrome score
Quality of life
Lead sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Bowel function assessment using Low anterior resection syndrome questionnaire
timeFrame: 5 years
Secondary outcomes:
measure: Risk factors: age
timeFrame: 5 years
measure: Risk factors: type of surgical procedure
timeFrame: 5 years
measure: Risk factors: preoperative chemoradiotherapy
timeFrame: 5 years
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
affiliation: Klaipėda University
name: Narimantas Samapavicius, Prof.
role: STUDY_CHAIR
References:
citation: 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.