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

NCT07008313 | Completed

• 1 other identifier: HebMU 20180065
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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

Keywords

acute gastrointestinal perforation; enhanced recovery after surgery; perioperative period

Outcome Measures

Primary Outcomes (3)

• change of the c-reactive protein in plasma

  1, 3, and 7 days after surgery

• change of the prealbumin in plasma

  1, 3, and 7 days after surgery

• change of the procalcitonin in plasma

  1, 3, and 7 days after surgery

Study Arms (2)

the enhanced recovery after surgery (ERAS) group

EXPERIMENTAL

Patients were rehabilitated using the ERAS concept.

Behavioral: The enhanced recovery after surgery

the conventional surgical treatment (CST) group

PLACEBO COMPARATOR

Traditional treatment methods.

Behavioral: Traditional treatment methods.

Interventions

The enhanced recovery after surgery 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 enhanced recovery after surgery (ERAS) group

Traditional treatment methods. BEHAVIORAL

Traditional treatment methods.

the conventional surgical treatment (CST) group

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: October 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 31, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

CN (1)