Enhanced Recovery After Surgery Promotes the Rehabilitation of Patients With Acute Gastrointestinal Perforation in Perioperative Period

NCT ID: NCT07008313

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2023-01-31

Brief Summary

The enhanced recovery after surgery(ERAS) has been gradually extended from its initial colorectal surgery to almost all surgical fields. However, there are few reports about the application value of ERAS in emergency surgery. The goal of this clinical trial is to evaluate the value of ERAS in the perioperative period of acute gastrointestinal perforation. All the patients will be treated by emergency operation. The changes of CRP, PA, PCT in Plasma 1 hour before operation and 1,3,7 days after operation, the operation time, the amount of bleeding during operation, the recovery time of intestinal function and the time of the first meal after operation,the incidence of postoperative complications, the degree of postoperative pain, the time of first out-of-bed activity, fatigue and mental status, quality of life, the length and the cost of hospital stay will be monitored and recorded.

Conditions

Acute Gastrointestinal Perforation; Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the enhanced recovery after surgery (ERAS) group

Patients were rehabilitated using the ERAS concept.

Group Type: EXPERIMENTAL

The enhanced recovery after surgery

Intervention Type: BEHAVIORAL

Enhanced recovery after surgery (ERAS) refers to a series of optimal management measures which are proved to be effective by evidence-based medical evidence in order to reduce patients' psychological and physiological traumatic stress reaction

the conventional surgical treatment (CST) group

Traditional treatment methods.

Group Type: PLACEBO_COMPARATOR

Traditional treatment methods.

Intervention Type: BEHAVIORAL

Traditional treatment methods.

Interventions

The enhanced recovery after surgery

Enhanced recovery after surgery (ERAS) refers to a series of optimal management measures which are proved to be effective by evidence-based medical evidence in order to reduce patients' psychological and physiological traumatic stress reaction

Intervention Type: BEHAVIORAL

Traditional treatment methods.

Traditional treatment methods.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age≥14years old and ≤80 years old
• The initial diagnosis is acute gastrointestinal perforation

Exclusion Criteria

• Patients with unconsciousness,or patients with past psychiatric history
• Patients with shock and/or severe organ failure
• Patients who are pregnant
• Patients with severe spinal deformity who are unable to receive epidural anesthesia

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chunjie Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HebMU 20180065

Identifier Type: -

Identifier Source: org_study_id