the Affiliated Hospital of Qingdao
Qingdao, Shandong, 266000, China
Location status: Recruiting
Location contact
Hao Chang
CONTACT
Yanbing Zhou
CONTACT
NCT Number: NCT06569966
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Qingdao, Shandong, 266000, China
Location status: Recruiting
Hao Chang
CONTACT
Yanbing Zhou
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 month after discharge, and 3, 6, and 12 months after surgery
low anterior resection syndrome score(0-42,Higher scores indicate more severe symptoms)
Time frame: up to 10 days after surgery
The first postoperative exhaust and defecation time
Time frame: up to 10 days after surgery
Concentration of C-reactive protein after surgery
Time frame: 1 month after discharge, and 3, 6, and 12 months after surgery
Quality of Life Questionnaire Core 30(0-100,standardscore,A higher score in the symptom domain indicates a worse quality of life)
Time frame: 1 month after discharge, and 3, 6, and 12 months after surgery
The Cleveland clinic fecal incontinence score(0-20,Higher scores indicate more severe symptoms)
Time frame: From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months
Weight change after rehabilitation
Time frame: 1 year after surgery
The number of emergency visits or rehospitalizations related to stoma closure
Time frame: 1 year after surgery
the incidence of postoperative intestinal obstruction (POI)
Contact information is provided by the study sponsor or research team.
The Affiliated Hospital of Qingdao University
Other
The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure: A Single Center Prospective Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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