ERAS Clinical Trial - Enhanced Recovery After Surgery Exercise Improve

Status Enrolling by invitation

Clinical Trial Summary

A randomized, controlled, clinical trial on the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery Objective to evaluate the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery Participants: Patients undergoing elective laparoscopic colorectal surgery over 18 years old. The research intervention was ERAS exercise The study design was a randomized, parallel controlled trial ERAS exercise in perioperative period as the experimental group. No ERAS exercise group was the control group. The sample size was estimated according to the main efficacy index ( the attenuation of frailty after 7 days surgery) of this study. It was assumed that the attenuation of frailty in the ERAS exercise group was better than that of the control group. The parameters were set as test level (alpha) of 0.050 using a two-sided two-sample unequal-variance t-test, β = 0.9, according to the results of previous clinical trials and combined with literature, the population mean difference was 0.6 with standard deviations of 0.8 for the experimental group and 0.8 for the control group. the experimental group: the control group was 1:1, 39 cases in each group, considering the 20% shedding rate, 49 cases in the experimental group and 49 cases in the control group were selected. 1. The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation. 2. The control group The patients do not take ERAS exercise in perioperative period. Efficacy evaluation 1. The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery. 2. Secondary endpoints included the 6-minute walk test (6MWT),nutritional risk screening (NRS2002), anxious and depressive states, activities of daily living (ADL),postoperative complications and mortality,short-term recovery quality,postoperative pain.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

ERAS
Frailty

Clinical Trial Details

NCT number	NCT04964856
Study type	Interventional
Source	First Affiliated Hospital of Chongqing Medical University
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	May 1, 2021
Completion date	February 1, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty — EEIPF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms