Acute Gastrointestinal PerforationNCT07008313
Enhanced Recovery After Surgery Promotes the Rehabilitation of Patients With Acute Gastrointestinal Perforation in Perioperative Period
A study testing The enhanced recovery after surgery and Traditional treatment methods. in people with Acute Gastrointestinal Perforation and Enhanced Recovery After Surgery, run by Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Acute Gastrointestinal Perforation, Enhanced Recovery After Surgery
- What is being tested?
- The enhanced recovery after surgery and Traditional treatment methods.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age≥14years old and ≤80 years old
- The initial diagnosis is acute gastrointestinal perforation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery Promotes the Rehabilitation of Patients With Acute Gastrointestinal Perforation, a Randomized Controlled Study
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.
- Being tested
- The enhanced recovery after surgery, Traditional treatment methods.
- Keywords
- acute gastrointestinal perforation, enhanced recovery after surgery, perioperative period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The enhanced recovery after surgeryBehavioural
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
Traditional treatment methods.Behavioural
Traditional treatment methods.
| Study group | Role | What they receive |
|---|---|---|
| the enhanced recovery after surgery (ERAS) group | Experimental | Patients were rehabilitated using the ERAS concept. Receives: Behavioral: The enhanced recovery after surgery |
| the conventional surgical treatment (CST) group | Placebo comparator | Traditional treatment methods. Receives: Behavioral: Traditional treatment methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the c-reactive protein in plasma
Measured: 1, 3, and 7 days after surgery
change of the prealbumin in plasma
Measured: 1, 3, and 7 days after surgery
change of the procalcitonin in plasma
Measured: 1, 3, and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Oct 2018
- Primary completion1 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastrointestinal PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjie Liu, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008313
- Sponsor's protocol ID
- HebMU 20180065
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Promotes the Rehabilitation of Patients With Acute Gastrointestinal Perforation, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07008313
- Acronym / sponsor ID
- HebMU 20180065
- Keywords
- acute gastrointestinal perforation, enhanced recovery after surgery, perioperative period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the enhanced recovery after surgery (ERAS) group | Experimental | Behavioral: The enhanced recovery after surgeryPatients were rehabilitated using the ERAS concept. |
| the conventional surgical treatment (CST) group | Placebo comparator | Behavioral: Traditional treatment methods.Traditional treatment methods. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age≥14years old and ≤80 years old
- The initial diagnosis is acute gastrointestinal perforation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The enhanced recovery after surgeryEnhanced 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 | Behavioural | the enhanced recovery after surgery (ERAS) group |
| Traditional treatment methods.Traditional treatment methods. | Behavioural | the conventional surgical treatment (CST) group |
Primary outcome
change of the c-reactive protein in plasma
Time frame: 1, 3, and 7 days after surgery
change of the prealbumin in plasma
Time frame: 1, 3, and 7 days after surgery
change of the procalcitonin in plasma
Time frame: 1, 3, and 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The enhanced recovery after surgery and Traditional treatment methods. in people with Acute Gastrointestinal Perforation and Enhanced Recovery After Surgery, run by Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the c-reactive protein in plasma (time frame: 1, 3, and 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.