NCT06182488

Brief Summary

The goal of this clinical trial is to test the safety and effectiveness of the ERAS protocols compared to a conventional care protocols in patients who received emergency laparotomy. The main question it aims to answer are: • Can the ERAS protocols be used safely and effectively in patients undergoing emergency laparotomy? Participants will be randomised into the ERAS group and the conventional group and will be given the ERAS protocols and the conventional protocols in the perioperative period. Researchers will compare the ERAS group with the conventional group to see if the ERAS programme is effective.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

29 days

First QC Date

November 21, 2023

Last Update Submit

December 12, 2023

Conditions

Acute AbdomenAbdominal TraumaEmergency Surgery

Keywords

Enhanced recovery after surgery (ERAS)Emergency surgeryAcute abdominal diseaseCombined anesthesiaGoal-directed fluid therapy

Outcome Measures

Primary Outcomes (1)

  • postoperative recovery time

    Postoperative recovery time that meets the relevant definitions in this study

    From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (5)

  • the rate of postoperative complications

    From enrollment to the end of treatment at 2 weeks

  • The time of first postoperative flatus

    From enrollment to the end of treatment at 2 weeks

  • The time to tolerate semi-fluid diet after surgery

    From enrollment to the end of treatment at 2 weeks

  • The time to tolerate soft food after surgery

    From enrollment to the end of treatment at 2 weeks

  • The rate of readmission (in 30 days)

    From enrollment to the end of treatment at 2 weeks

Study Arms (2)

ERAS Group

EXPERIMENTAL

According to the ERAS guidelines, the ERAS group received ERAS protocol.

Other: ERAS protocols

Conventional group

OTHER

Conventional perioperative interventions

Other: Conventional protocols

Interventions

ERAS protocolsOTHER

ERAS protocols for emergency abdominal surgery

ERAS Group
Conventional protocolsOTHER

Conventional protocols for emergency abdominal surgery

Conventional group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages 18-70,
  • Patients who completed the preoperative examination and preoperative diagnosis within 4 hours after admission for acute abdomen diseases,
  • Required emergency surgery within 6 hours from surgeon encounter.

You may not qualify if:

  • Patients who refused to be enrolled in this study;
  • Patients with any psychiatric or neurological disorders;
  • Pseptic shock at admission;
  • Duration of symptoms more than five days;
  • Patients with contraindications to the placement of lumbar epidural catheters, such as coagulation disorders, severe sepsis, etc.;
  • Presence of preoperative factors affecting wound healing (e.g. long-term steroid use);
  • Patients with extra-abdominal injuries or terminal malignancy, or patients requiring damage control surgery;
  • Patients found intraoperatively to require any procedure other than splenectomy, partial hepatectomy or liver repair, bowel resection and anastomosis, laparoscopic cholecystectomy and appendectomy, and gastrointestinal perforation repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Abdomen, AcuteAbdominal Injuries

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveWounds and Injuries

Study Officials

  • Hong Zheng, MD

    Tianjin First Central Hospital

    STUDY CHAIR

Central Study Contacts

Jianing Lu, MD

CONTACT

86-022-60910136lujianing2006@163.com

Hong Zheng, MD

CONTACT

zhenghongyx@139.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A single center randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 21, 2023

First Posted

December 27, 2023

Study Start

November 1, 2023

Primary Completion

November 30, 2023

Study Completion

May 30, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)