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

Qingdao University

Status: Enrolling

Conditions: Low Anterior Resection Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06569966

Prehab-LARS2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Prehabilitation Group

Experimental group

Description:

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.

Treatment:

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

Perioperative management group

No Intervention group

Description:

Perioperative management group