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Набира участници Фаза 2/3 NCT07537998

Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.

Фаза 2/3 – комбинирано изпитване
Заболявания: Low Anterior Resection Syndrome Rectal Cancer

Спонсор: Pei-Rong Ding

Налично на: БГ
Обобщение
The goal of this clinical trial is to learn if antegrade intestinal fluid reinfusion works to prevent low anterior resection syndrome (LARS) in patients with prophylactic ileal stoma. The main questions it aims to answer are: 1. Does it work to prevent LARS by antegrade intestinal fluid reinfusion before performing the ileostomy reversal surgery? 2. Is antegrade intestinal fluid reinfusion more effective than water infusion in preventing LARS. Participants will: 1. Receive either antegrade intestinal fluid reinfusion or antegrade water infusion through ileal stoma based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.
Кой може да участва
Inclusion Criteria: * Patients with mid to low rectal cancer (within 10cm of the anal verge) who undergo radical DIXON+ileostomy surgery. * General situation is well and one can take care of themselves. * Anal digital examination confirms that the anastomotic site has fully healed 1 month after surgery. * The anal sphincter function is good, and the ilestomy reverse surgery has not been completed. * Regardless of whether preoperative radiotherapy or chemotherapy has been received. Exclusion Criteria: * Patients with anastomotic leakage after rectal cancer surgery. * The patient's general physical condition is poor and they are unable to take care of themselves. * Expected inability to retract the stoma. * Patients with preoperative inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, etc. * inability to treat according to the plan, poor compliance.
Интервенции
intestinal fluid infusion
COMBINATION_PRODUCT
potable water
COMBINATION_PRODUCT
Места на провеждане 1
Китай (1)
Sun Yat-sen University Cancer Center
Guangzhou , Guangdong
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
10.04.2026
Крайна дата
10.04.2028
Регистрационен номер
NCT07537998
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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