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The goal of this clinical trial is to learn if antegrade intestinal fluid reinfusion works to prevent low anterior resection syndrome (LARS) in patients with prophylactic ileal stoma. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intestinal fluid reinfusion | Experimental | Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study. After preparing the autologous intestinal fluid, it is diluted with warm saline to a volume of 200-500 ml. It is then returned through the distal end of the ileal stoma in a retrograde manner, once every other day. |
|
| Water infusion | Active Comparator | Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study. Prepare 200-500 ml of potable water, and then infuse it antegradely from the distal end of the ileal stoma, once every other day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intestinal fluid infusion | Combination Product | Prepare autologous intestinal fluid and perform rantegrade reinfusion from the distal end of the stoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LARS score(m1) | Improvement in LARS score 1 month after ileostomy reversal surgery between the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score). | 1 month after ileostomy reversal surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major LARS rate(m1) | Major LARS rate 1 month after ileostomy reversal | 1 month after ileostomy reversal |
| LARS score (m0-12) | Trajectory of change of LARS score after ileostomy reversal surgery in the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peirong Ding, M.D | Contact | 86-020-87343920 | dingpr@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| potable water | Combination Product | Infuse potable water through the distal end of the stoma. |
|
| 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery |
| MSKCC BFI | Memorial Sloan Kettering Cancer Centre Bowel Function Instrument | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery |
| Wexner score | The Wexner scoring system is a clinical tool used to assess the severity of constipation. Mainly used to quantify the constipation symptoms of patients and their impact on their quality of life. Including five aspects: defecation frequency, difficulty in defecation, emptying sensation, abdominal pain, and time spent in the toilet. The total score range is 0-25 points. A score below 7 points is considered mild constipation, 7-15 points is moderate constipation, and above 15 points is severe constipation. | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery |
| quality of life for rectal cancer patients | quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 ) | 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D060766 | Drinking Water |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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