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

NCT ID: NCT06569966

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Low Anterior Resection Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Perioperative management group

Perioperative management group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanbing Zhou

Role: STUDY_CHAIR

the Affiliated Hospital of Qingdao

Locations

the Affiliated Hospital of Qingdao

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanbing Zhou

Role: CONTACT

zhouyanbing@qduhospital.cn

+86 137 0897 1773

Facility Contacts

Yanbing Zhou

Role: primary

zhouyanbing@qduhospital.cn

+86 137 0897 1773

Hao Chang

Role: backup

1013305163@qq.com

+86 178 5284 0122

Other Identifiers

Prehab-LARS2024

Identifier Type: -

Identifier Source: org_study_id