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

NCT06569966 | Recruiting DMC

• 1 other identifier: Prehab-LARS2024
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• the intestinal function recovery

  up to 10 days after surgery

• Concentration of C-reactive protein

  up to 10 days after surgery

• Quality of Life Questionnaire Core 30

  1 month after discharge, and 3, 6, and 12 months after surgery

• fecal incontinence

  1 month after discharge, and 3, 6, and 12 months after surgery

• Weight change after rehabilitation

  From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months

Study Arms (2)

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.

Behavioral: preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon

Perioperative management group

NO INTERVENTION

Perioperative management group

Interventions

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

Prehabilitation Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanbing Zhou

  the Affiliated Hospital of Qingdao

  STUDY CHAIR

Central Study Contacts

Yanbing Zhou

CONTACT

+86 137 0897 1773; zhouyanbing@qduhospital.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 26, 2024
• Study Start: July 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

CN (1)