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This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.
The patients in the experimental group collected the contents of the ileostomyand placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded.Patients in the control group received routine perioperative management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation Group | Experimental | The contents of the ileostomy were collected and placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded. |
|
| Perioperative management group | No Intervention | Perioperative management group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon | Behavioral | The contents of the ileostomy were collected and placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded |
| Measure | Description | Time Frame |
|---|---|---|
| The extent of low anterior resection syndrome | low anterior resection syndrome score(0-42,Higher scores indicate more severe symptoms) | 1 month after discharge, and 3, 6, and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the intestinal function recovery | The first postoperative exhaust and defecation time | up to 10 days after surgery |
| Concentration of C-reactive protein | Concentration of C-reactive protein after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbing Zhou | Contact | +86 137 0897 1773 | zhouyanbing@qduhospital.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanbing Zhou | the Affiliated Hospital of Qingdao | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affiliated Hospital of Qingdao | Recruiting | Qingdao | Shandong | 266000 | China |
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| up to 10 days after surgery |
| Quality of Life Questionnaire Core 30 | Quality of Life Questionnaire Core 30(0-100,standardscore,A higher score in the symptom domain indicates a worse quality of life) | 1 month after discharge, and 3, 6, and 12 months after surgery |
| fecal incontinence | The Cleveland clinic fecal incontinence score(0-20,Higher scores indicate more severe symptoms) | 1 month after discharge, and 3, 6, and 12 months after surgery |
| Weight change after rehabilitation | Weight change after rehabilitation | From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months |
| The number of emergency visits or rehospitalizations related to stoma closure | The number of emergency visits or rehospitalizations related to stoma closure | 1 year after surgery |
| the incidence of postoperative intestinal obstruction (POI) | the incidence of postoperative intestinal obstruction (POI) | 1 year after surgery |
| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| 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 |
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