Emergent SurgeryNCT06570018
Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer
A study testing Post operative enhanced recovery elements in people with Emergent Surgery and Perforated Peptic Ulcer, run by Assiut University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome. The current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergent Surgery, Perforated Peptic Ulcer
- What is being tested?
- Post operative enhanced recovery elements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 15 Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranged from 18 to 65 years,
- Diagnosed with perforated peptic ulcer,
- Ulcer size less than 10 mm.
- Underwent emergent surgical intervention
Who cannot join
- Malignant ulcer.
- Other GIT diseases (corn's disease \& ulcerative colitis)
- Pregnant women
- Psychiatric or neurological illness.
- Who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome.
The current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better gastrointestinal quality of life after implementing post operative enhanced recovery in patients with perforated peptic ulcer.
Read the detailed description
This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcomes.
Methods: Quasi- experimental research design was utilized. The study was conducted at Assiut University Hospital.
A purposive sample of thirty patients (study group) who received postoperative enhanced recovery after open surgical repair of perforated peptic ulcer compared with thirty patients (control group) who exposed to routine care.
patient assessment sheet and gastrointestinal quality of life index were the tools used for data collection.
- Conditions
- Emergent Surgery, Perforated Peptic Ulcer
- Being tested
- Post operative enhanced recovery elements
- 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.
Post operative enhanced recovery elementsProcedure or surgery
According to the study group the researchers collaborated with surgeons, nurses, and anesthesiologists to implement post operative enhanced recovery protocol that defined clearly in the following elements Early nutrition, Early mobilization, Non-opioid analgesia. Early removal of abdominal drains and tubes throughout the patients' hospital stay up to their discharge.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery group | Experimental | who received postoperative enhanced recovery after open surgical repair for perforated peptic ulcer Receives: Procedure: Post operative enhanced recovery elements |
| Control group | No intervention | who exposed to standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal functional recovery (first bowel movement)
Tool; Patient assessment sheet
- It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first bowel movement) through physical examination.
- The mean score of time for two groups was compared
Measured: Within the first 24 hours postoperative or more
Gastrointestinal functional recovery(first flatus passage)
Tool; Patient assessment sheet
- It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first flatus passage) through physical examination. the mean score of time for two groups was compared
Measured: Within the first 24 hours postoperative or more
Gastrointestinal functional recovery(first stool passage)
Tool; Patient assessment sheet
- It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first stool passage) postoperative.through health history.
The mean score of time for two groups was compared
Measured: First stool passage within three days postoperative or more
postoperative complications
post operative complications included complications that occured within 30- days post operative. Every patient had been assessed for developing pneumonia, admission to critical care, abdominal collection, intra-abdominal abscess, suture leakage, omental patch leakage, septic shock, prolonged ileus, surgical site infection, urinary tract infection, deep venous thrombosis (DVT), and reoperation
Measured: Immediately post operative up to thirty days postoperative
Legnth of hospital stay
Hospitalization duration from admission up to discharge Mean score of days for two groups will be compared.
Measured: seven days up to two weeks
Secondary outcomes (1)
gastrointestinal quality of life
gastrointestinal quality of life was evaluated for all patients before discharge and after thirty days postoperative using Gastrointestinal quality of life index (Eypasch, 1993).
It is a 36-item scale divided into five domains; GIT symptoms (10 items), physical (6 items), emotion (6 items), social (2 items) and disease specific (8 items) Cronbach's alpha was 0.89
Scoring:
Each item is based on a 0-4 Likert scale with 0 being least desirable to 4 being the most desirable option. The total scores represent Gastrointestinal Quality of Life Index. It ranges from 0 to 144 with higher scores indicating a better quality of life
Measured: Before hospital dicharge and after thirty days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Oct 2023
- Primary completion15 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergent SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna A. Desouky, MD, Assiut University
- Investigators
- Mahmoud Ayoub, Ass. prof., Principal investigator, Assiut University -Assiut city
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570018
- Sponsor's protocol ID
- Enhanced recovery
- Status last verified
- Jan 2025
- First submitted
- 20 Aug 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desoky AA, Ayoub MT, Mostafa NM, Hashem EM, Mohammed MA. Short-term outcome following postoperative enhanced recovery implementation in patients with perforated peptic ulcer. Eur J Med Res. 2025 Apr 4;30(1):234. doi: 10.1186/s40001-025-02432-7.
PubMed 40186297
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer
- ClinicalTrials.gov ID
- NCT06570018
- Acronym / sponsor ID
- Enhanced recovery
- Conditions
- Emergent Surgery, Perforated Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 26 Aug 2024 (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.
This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome.
The current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better gastrointestinal quality of life after implementing post operative enhanced recovery in patients with perforated peptic ulcer.
Detailed description
This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcomes.
Methods: Quasi- experimental research design was utilized. The study was conducted at Assiut University Hospital.
A purposive sample of thirty patients (study group) who received postoperative enhanced recovery after open surgical repair of perforated peptic ulcer compared with thirty patients (control group) who exposed to routine care.
patient assessment sheet and gastrointestinal quality of life index were the tools used for data collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery group | Experimental | Procedure: Post operative enhanced recovery elementswho received postoperative enhanced recovery after open surgical repair for perforated peptic ulcer |
| Control group | No intervention | –who exposed to standard care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ranged from 18 to 65 years,
- Diagnosed with perforated peptic ulcer,
- Ulcer size less than 10 mm.
- Underwent emergent surgical intervention
Key exclusion criteria (5 listed)
- Malignant ulcer.
- Other GIT diseases (corn's disease \& ulcerative colitis)
- Pregnant women
- Psychiatric or neurological illness.
- Who refused to participate in the study
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 |
|---|---|---|
| Post operative enhanced recovery elementsAccording to the study group the researchers collaborated with surgeons, nurses, and anesthesiologists to implement post operative enhanced recovery protocol that defined clearly in the following elements Early nutrition, Early mobilization, Non-opioid analgesia. Early removal of abdominal drains and tubes throughout the patients' hospital stay up to their discharge. | Procedure or surgery | Enhanced recovery group |
Primary outcome
Gastrointestinal functional recovery (first bowel movement)
Time frame: Within the first 24 hours postoperative or more
Tool; Patient assessment sheet * It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first bowel movement) through physical examination. * The mean score of time for two groups was compared
Gastrointestinal functional recovery(first flatus passage)
Time frame: Within the first 24 hours postoperative or more
Tool; Patient assessment sheet * It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first flatus passage) through physical examination. the mean score of time for two groups was compared
Gastrointestinal functional recovery(first stool passage)
Time frame: First stool passage within three days postoperative or more
Tool; Patient assessment sheet - It was developed by researchers based on literatures review to assess postoperative clinical data (part 2) as gastrointestinal functional recovery (first stool passage) postoperative.through health history. The mean score of time for two groups was compared
postoperative complications
Time frame: Immediately post operative up to thirty days postoperative
post operative complications included complications that occured within 30- days post operative. Every patient had been assessed for developing pneumonia, admission to critical care, abdominal collection, intra-abdominal abscess, suture leakage, omental patch leakage, septic shock, prolonged ileus, surgical site infection, urinary tract infection, deep venous thrombosis (DVT), and reoperation
Legnth of hospital stay
Time frame: seven days up to two weeks
Hospitalization duration from admission up to discharge Mean score of days for two groups will be compared.
1 secondary outcome
gastrointestinal quality of life
Time frame: Before hospital dicharge and after thirty days postoperative
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 29 Jan 2025.
- Derived from this study: PubMed 40186297Desoky AA, Ayoub MT, Mostafa NM, Hashem EM, Mohammed MA. Short-term outcome following postoperative enhanced recovery implementation in patients with perforated peptic ulcer. Eur J Med Res. 2025 Apr 4;30(1):234. doi: 10.1186/s40001-025-02432-7.
- 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.
Mahmoud Ayoub, Ass. prof. principal investigator
Assiut University -Assiut city
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post operative enhanced recovery elements in people with Emergent Surgery and Perforated Peptic Ulcer, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 5 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 29 Jan 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 Egypt. 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?
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?
Gastrointestinal functional recovery (first bowel movement) (time frame: Within the first 24 hours postoperative or more). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570018, which also lists 1 linked publication.
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 29 Jan 2025.