Hyper-ERAS Program for Highly Selective Colorectal Cancer Patients

NCT ID: NCT06256315

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-08-01

Brief Summary

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This clinical trial aims to explore the safety and effectiveness of the Hyper-ERAS rehabilitation protocol for colorectal cancer patients and the feasibility of discharge within 48 hours.

Detailed Description

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The Hype-ERAS protocol includes preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of drainage tube, urinary catheter, and gastric tube, discharge within 48 hours after surgery, and standardized follow-up outside the hospital. Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A. Patients who were treated with Hyper-ERAS protocol and had a postoperative hospital stay of more than 48 hours were classified as group B. Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C (Control group). The postoperative recovery of each group was compared to explore the safety and efficacy of Hyper-ERAS rehabilitation program in patients with colorectal cancer.

Conditions

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Colorectal Cancer ERAS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A:Hyper-ERAS(Length of Postoperative Hospital Stay<48h)

Patients treated with the Hyper-ERAS rehabilitation protocol and discharged within 48 hours were in group A.

Group Type EXPERIMENTAL

Hyper-ERAS Program

Intervention Type PROCEDURE

Patients who met the inclusion criteria were treated with Hype-ERAS protocol, including preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of the drainage tube, urinary catheter, and gastric tube, and discharge within 48 hours or more than 48 hours safter surgery, and closely and standardized follow-up outside the hospital.

Group B:Hyper-ERAS(LOPS>48h)

Patients treated with the ERAS rehabilitation protocol and discharged in more than 48 hours were in group B.

Group Type EXPERIMENTAL

Hyper-ERAS Program

Intervention Type PROCEDURE

Patients who met the inclusion criteria were treated with Hype-ERAS protocol, including preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of the drainage tube, urinary catheter, and gastric tube, and discharge within 48 hours or more than 48 hours safter surgery, and closely and standardized follow-up outside the hospital.

Group C:Control group

Patients eligible but not treated with the Hyper-ERAS rehabilitation protocol during the same period were in group C.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyper-ERAS Program

Patients who met the inclusion criteria were treated with Hype-ERAS protocol, including preoperative education, intraoperative quality control, postoperative preventive analgesia, early ambulation, early recovery of diet, early removal of the drainage tube, urinary catheter, and gastric tube, and discharge within 48 hours or more than 48 hours safter surgery, and closely and standardized follow-up outside the hospital.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Pathologically confirmed colorectal cancer.
2. The position of the anastomosis is above the peritoneal reflection.
3. Age range from 18 to 79 years old.
4. No surgical contraindications.
5. The patient has good compliance and can understand the concept of rapid recovery.
6. Possess basic nursing conditions outside the hospital, and can arrive at the hospital within 30 minutes after discharge.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Lin Wang

Unit III & Ostomy Service, Gastrointestinal Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Cancer Hospital & Institute

Beijing, Haidian District, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Changlong Li

Role: CONTACT

+861088196086

Lin Wang, M.D.

Role: CONTACT

+8613910975011

Facility Contacts

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Lin Wang, M.D.

Role: primary

+8613910975011

Changlong Li, M.D.

Role: backup

+8618954156864

Other Identifiers

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PKUCH Hyper-ERAS research

Identifier Type: -

Identifier Source: org_study_id

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