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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal irrigation | Experimental | Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months. |
|
| Best supportive therapy | Active Comparator | Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal irrigation | Procedure | Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with major low anterior resection syndrome score (LARS score) | at the time of 6 months since the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life impairment assessed by Short Form 36 (SF-36) | Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire. | at the time of 6, 12 months since the start of treatment |
| Number of participants with major low anterior resection syndrome score (LARS score) |
| Measure | Description | Time Frame |
|---|---|---|
| Anorectal function impairment | Anorectal function will be assessed by anorectal manometry. | at the time of 6 months since the start of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiyuan Qin, M.D. | Contact | 86-20-38254052 | qinqy3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiyuan Qin, M.D. | The Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Best supportive therapy | Other | Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication. |
|
| at the time of 1, 3, 12 months since the start of treatment |
| Bowel function impairment | Bowel function will be assessed by Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI). Stool frequency will be recorded in the day and night. | at the time of 6, 12 months since the start of treatment |
| Fecal continence impairment | Fecal incontinence will be assessed by Wexner incontinence scale. | at the time of 6, 12 months since the start of treatment |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |