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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Behavioral: preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanbing Zhou; Phone Number: +86 137 0897 1773; Email: zhouyanbing@qduhospital.cn

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • the Affiliated Hospital of Qingdao
      • Contact: Yanbing Zhou; Phone Number: +86 137 0897 1773; Email: zhouyanbing@qduhospital.cn
      • Contact: Hao Chang; Phone Number: +86 178 5284 0122; Email: 1013305163@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 18-85 years old
• Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
• rectal cancer confirmed by preoperative pathology
• in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
• prophylactic ileostomy.

Exclusion Criteria:

• cannot complete treatment
• the history of the anorectal surgery
• preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
• postoperative anastomotic fistula and stricture
• during pregnancy or breastfeeding women
• with uncontrolled seizures, central nervous system disease or a history of mental disorders
• the last five years have other history of malignant disease cured except skin cancer and cervical carcinoma in situ
• clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association class II or worse 9) severe congestive heart failure or major arrhythmia requiring medical intervention, or myocardial infarction within the previous 6 months
• has a history of cerebral infarction or cerebral hemorrhage within the past 6 months
• organ transplantation requiring immunosuppressive therapy
• serious uncontrolled repeated infections, or other serious with disease of control;
• moderate or severe renal impairment creatinine clearance equal to or less than 50ml/min, or upper limit of normal (ULN)
• emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
• in screening the first 4 weeks received study medication or treatment (to participate in other test).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation Group; 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.	Behavioral: preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon; 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
No Intervention: Perioperative management group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Chair: Yanbing Zhou, the Affiliated Hospital of Qingdao

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Low Anterior Resection Syndrome
• Other Study ID Numbers: Prehab-LARS2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No