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NCT Number: NCT06569966

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. The extent of low anterior resection syndrome

    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)

Secondary outcomes

  1. the intestinal function recovery

    Time frame: up to 10 days after surgery

    The first postoperative exhaust and defecation time

  2. Concentration of C-reactive protein

    Time frame: up to 10 days after surgery

    Concentration of C-reactive protein after surgery

  3. Quality of Life Questionnaire Core 30

    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)

  4. fecal incontinence

    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)

  5. Weight change after rehabilitation

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

    Weight change after rehabilitation

  6. The number of emergency visits or rehospitalizations related to stoma closure

    Time frame: 1 year after surgery

    The number of emergency visits or rehospitalizations related to stoma closure

  7. the incidence of postoperative intestinal obstruction (POI)

    Time frame: 1 year after surgery

    the incidence of postoperative intestinal obstruction (POI)

Study contacts

Contact information is provided by the study sponsor or research team.

Yanbing Zhou

CONTACT

[email protected]

+86 137 0897 1773

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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