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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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, a

Первичные конечные точки

• The extent of low anterior resection syndrome [Срок оценки: 1 month after discharge, and 3, 6, and 12 months after surgery]

Вторичные конечные точки (7)

• the intestinal function recovery [Срок оценки: up to 10 days after surgery]
• Concentration of C-reactive protein [Срок оценки: up to 10 days after surgery]
• Quality of Life Questionnaire Core 30 [Срок оценки: 1 month after discharge, and 3, 6, and 12 months after surgery]
• fecal incontinence [Срок оценки: 1 month after discharge, and 3, 6, and 12 months after surgery]
• Weight change after rehabilitation [Срок оценки: From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months]
• The number of emergency visits or rehospitalizations related to stoma closure [Срок оценки: 1 year after surgery]
• the incidence of postoperative intestinal obstruction (POI) [Срок оценки: 1 year after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the Affiliated Hospital of Qingdao — Qingdao

Идентификаторы

NCT: NCT06569966 · Prehab-LARS2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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