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The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are:
Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | No Intervention | The standard of care (SOC) was implemented following low anterior resection, which included the distribution of pamphlets and instructional videos to patients and their caregivers. | |
| antegrade enema | Experimental | Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. | |
| retrograde enema | Experimental | Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered retrogradely via the anus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transanal irrigation | Other | The enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| low anterior resection syndrome score (LARS score) | Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal |
| Measure | Description | Time Frame |
|---|---|---|
| bowel function | Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) | before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal |
| quality of life for rectal cancer patients |
| Measure | Description | Time Frame |
|---|---|---|
| Ostomy Adjustment Inventory-20 (OAI-20) | 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively | |
| A quality of life questionnaire for people with an ostomy (Stoma-QoL) | 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai Hu, M.D. | Contact | 8613540662185 | Hu_hai2019@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China | Chengdu, Sichuan | China |
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| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| antegrade enema | Other | The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes. |
quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )
| before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal |
| quality of sleep | Pittsburgh Quality Index (PSQI) | before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction |
| Anal drainage and irritation during ileostomy (self-made) | 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively |
|
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |