Clinical trial NCT04758195: Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome
Official title: A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Anterior Resection Syndrome
Keywords: Low Anterior Resection Syndrome
Transanal irrigation
Rectal cancer
Prevention
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.


Eligibility criteria: Inclusion Criteria:

* Age: 18-75 years old
* Curative low anterior resection for rectal cancer with diverting stoma
* Stoma closure within 1 month
* Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
* No evidence of anastomotic leakage or severe stenosis

Exclusion Criteria:

* Tumor recurrence or distant metastasis
* Secondary operation with stoma
* Prior disease impairing bowel function except for rectal cancer
* Any contraindication for transanal irrigation
* Pregnant or nursing
* Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
* Cognitive or psychological disorder

Primary outcomes:
measure: Number of participants with major low anterior resection syndrome score (LARS score)
timeFrame: at the time of 6 months since the start of treatment
Secondary outcomes:
measure: Quality of life impairment assessed by Short Form 36 (SF-36)
timeFrame: at the time of 6, 12 months since the start of treatment
measure: Number of participants with major low anterior resection syndrome score (LARS score)
timeFrame: at the time of 1, 3, 12 months since the start of treatment
measure: Bowel function impairment
timeFrame: at the time of 6, 12 months since the start of treatment
measure: Fecal continence impairment
timeFrame: at the time of 6, 12 months since the start of treatment
Other outcomes:
measure: Anorectal function impairment
timeFrame: at the time of 6 months since the start of treatment
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Qiyuan Qin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: