Hospital StayNCT04039646
ERAS in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair
A study testing ERAS treatment in people with Hospital Stay and Hospital Cost, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hospital Stay, Hospital Cost
- What is being tested?
- ERAS treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Mar 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perforated ulcer less than 10 mm in size
- Patients received laprascopic repair
Who cannot join
- -
- 1. refusal to join the study or sign the informed consent form 3. age younger than 18 years 3.the presence of any psychiatric or neurologic disease 4. class 3 and 4 surgical patients according to the classification of The American Society of Anesthesiologists 5. septic shock on admission 6. pregnancy 7. multiple perforated peptic ulcers 8. spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair 9.conversion to open technique 10. perforated ulcers that were not amenable to Graham patch repair because of size or technical considerations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Zhen Jun Wang, M.D., 86-013601393711, wzhj611@163.com
Zhen Jun Wang
About this study
Official title: Enhanced Recovery After Surgery in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair, a Randomised Controlled Clinical Trial
Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. The aim of this randomized controlled clinical trial was to investigate the feasibility of enhanced postoperative recovery pathways in patients who underwent laparoscopic repair for Perforated peptic ulcer.
Read the detailed description
Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Randomization will be made at the end of the surgical procedure. Patients will be included in groups 1 or2. Group 1 is the control group and will receive standard postoperative care, and group 2 is the ERAS group.The aim of this randomized controlled clinical trial was to investigate the feasibility of ERAS in patients who underwent laparoscopic repair for Perforated peptic ulcer.
- Conditions
- Hospital Stay, Hospital Cost
- Being tested
- ERAS treatment
- Keywords
- Perforated peptic ulcer, Enhanced recovery after surgery, Laparoscopic repair, Complications
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS treatmentCombination product
The ERAS group had an enhanced postoperative recovery protocol. The gastric content was aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia. and also early feeding and move.
| Study group | Role | What they receive |
|---|---|---|
| Standard postoperative care group | Active comparator | Patients received standard postoperative care as ususal. Receives: Combination Product: ERAS treatment |
| ERAS group | Experimental | Patients received postoperative ERAS treatment. Receives: Combination Product: ERAS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
The time patients stay in hospital.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital StayStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Li Hua Tian, Principal investigator, Ethics center, Beijing Chaoyang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039646
- Sponsor's protocol ID
- RASS-01
- Status last verified
- Feb 2021
- First submitted
- 28 Jul 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair, a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04039646
- Acronym / sponsor ID
- RASS-01
- Conditions
- Hospital Stay, Hospital Cost
- Keywords
- Perforated peptic ulcer, Enhanced recovery after surgery, Laparoscopic repair, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 31 Jul 2019 (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.
Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. The aim of this randomized controlled clinical trial was to investigate the feasibility of enhanced postoperative recovery pathways in patients who underwent laparoscopic repair for Perforated peptic ulcer.
Detailed description
Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Randomization will be made at the end of the surgical procedure. Patients will be included in groups 1 or2. Group 1 is the control group and will receive standard postoperative care, and group 2 is the ERAS group.The aim of this randomized controlled clinical trial was to investigate the feasibility of ERAS in patients who underwent laparoscopic repair for Perforated peptic ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard postoperative care group | Active comparator | Combination Product: ERAS treatmentPatients received standard postoperative care as ususal. |
| ERAS group | Experimental | Combination Product: ERAS treatmentPatients received postoperative ERAS treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Perforated ulcer less than 10 mm in size
- Patients received laprascopic repair
Key exclusion criteria (2 listed)
- -
- 1. refusal to join the study or sign the informed consent form 3. age younger than 18 years 3.the presence of any psychiatric or neurologic disease 4. class 3 and 4 surgical patients according to the classification of The American Society of Anesthesiologists 5. septic shock on admission 6. pregnancy 7. multiple perforated peptic ulcers 8. spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair 9.conversion to open technique 10. perforated ulcers that were not amenable to Graham patch repair because of size or technical considerations
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 |
|---|---|---|
| ERAS treatmentThe ERAS group had an enhanced postoperative recovery protocol. The gastric content was aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia. and also early feeding and move. | Combination product | ERAS group, Standard postoperative care group |
Primary outcome
Hospital stay
Time frame: 30 days
The time patients stay in hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Li Hua Tian principal investigator
Ethics center, Beijing Chaoyang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS treatment in people with Hospital Stay and Hospital Cost, run by Beijing Chao Yang Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Gang Han, MD (+86013522867841, hjg211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital stay (time frame: 30 days). 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 8 Feb 2021.