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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Prehabilitation GroupExperimental treatment 1 intervention
Group B: Perioperative management groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The extent of low anterior resection syndrome

low anterior resection syndrome score(0-42,Higher scores indicate more severe symptoms)

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

Secondary outcomes

1

the intestinal function recovery

The first postoperative exhaust and defecation time

Time frame
up to 10 days after surgery
2

Concentration of C-reactive protein

Concentration of C-reactive protein after surgery

Time frame
up to 10 days after surgery
3

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)

Time frame
1 month after discharge, and 3, 6, and 12 months after surgery
4

fecal incontinence

The Cleveland clinic fecal incontinence score(0-20,Higher scores indicate more severe symptoms)

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

Other outcomes

Sponsors and contacts

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