Peptic Ulcer PerforationsNCT06084741
Omitting Drains After Repair of Peptic Ulcer Perforations
A study testing Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations and Using intraabdominal drains in people with Peptic Ulcer Perforations, run by Cairo University at 1 site in Egypt.
Trial summary
. This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Perforations
- What is being tested?
- Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations and Using intraabdominal drains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2023to 25 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.
Who cannot join
- preoperative shock on admission.
- Delayed presentation more than 24 hours.
- known malignant gastric ulcers confirmed by histopathology.
- the presence of neuropsychiatric disease, pregnant and lactating women.
- predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV/AIDS.
- Intraoperative findings consistent with malignant ulcers. • American Society of Anesthesiologists grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study
. This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.
Read the detailed description
Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.
- Conditions
- Peptic Ulcer Perforations
- Being tested
- Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations, Using intraabdominal drains
- 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.
Omitting of usage of intraabdominal drains after repair of peptic ulcer perforationsOther
omitting the intraabdominal drains
Using intraabdominal drainsOther
The investigators will put intraabdominal drains
| Study group | Role | What they receive |
|---|---|---|
| Drain group | Active comparator | In Group A the investigators will put intraabdominal drains Receives: Other: Using intraabdominal drains |
| No drain group | Experimental | The investigators will not put any intraabdominal drains Receives: Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days of hospital stay
hospital stay length
Measured: Up to 30 days
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
Measured: 30 days
incidence of Post operative repair leak
incidence of Post operative repair leak
Measured: 30 days
Secondary outcomes (3)
number of days before frist bowel motion
number of days before frist bowel motion
Measured: 7 days
severity of operative pain measured by Visual Analogue Scale (VAS
from 1 to 10 1 indicated minimum pain and 10 maximum pain
Measured: 7 days
INCIDENCE OF postoperative nausea and vomiting (PONAV
INCIDENCE OF postoperative nausea and vomiting (PONAV
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start25 Mar 2023
- Primary completion25 Feb 2024
- Study completion25 Mar 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 Peptic Ulcer PerforationsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elshwadfy Nageeb, Cairo University
- Investigators
- Mohammed ElShwadfy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084741
- Sponsor's protocol ID
- N-79-2023
- Status last verified
- Aug 2025
- First submitted
- 9 Oct 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nageeb ME, Tobar W, Saqr A, Ragab AA, Elansary AMSEO. No drains versus drains after perforated peptic ulcer repair: A randomized controlled trail. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2137-2145. doi: 10.1007/s00068-024-02551-6. Epub 2024 Jun 15.
PubMed 38878063
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study
- ClinicalTrials.gov ID
- NCT06084741
- Acronym / sponsor ID
- N-79-2023
- Conditions
- Peptic Ulcer Perforations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 16 Oct 2023 (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 ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.
Detailed description
Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Drain group | Active comparator | Other: Using intraabdominal drainsIn Group A the investigators will put intraabdominal drains |
| No drain group | Experimental | Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforationsThe investigators will not put any intraabdominal drains |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.
Key exclusion criteria (6 listed)
- preoperative shock on admission.
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 |
|---|---|---|
| Omitting of usage of intraabdominal drains after repair of peptic ulcer perforationsomitting the intraabdominal drains | Other | No drain group |
| Using intraabdominal drainsThe investigators will put intraabdominal drains | Other | Drain group |
Primary outcome
number of days of hospital stay
Time frame: Up to 30 days
hospital stay length
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
Time frame: 30 days
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
incidence of Post operative repair leak
Time frame: 30 days
incidence of Post operative repair leak
3 secondary outcomes
number of days before frist bowel motion
Time frame: 7 days
severity of operative pain measured by Visual Analogue Scale (VAS
Time frame: 7 days
INCIDENCE OF postoperative nausea and vomiting (PONAV
Time frame: 7 days
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 26 Aug 2025.
- Derived from this study: PubMed 38878063Nageeb ME, Tobar W, Saqr A, Ragab AA, Elansary AMSEO. No drains versus drains after perforated peptic ulcer repair: A randomized controlled trail. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2137-2145. doi: 10.1007/s00068-024-02551-6. Epub 2024 Jun 15.
- Individual participant dataSharing planned: No
Related trials for Peptic Ulcer Perforations
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
Not yet recruiting
Falciformopexy for Treatment Perforated Peptic Ulcer.
Perforated Peptic Ulcer
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.
Mohammed ElShwadfy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations and Using intraabdominal drains in people with Peptic Ulcer Perforations, run by Cairo 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 1 inclusion and 6 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 26 Aug 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?
number of days of hospital stay (time frame: Up to 30 days). 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?
On the ClinicalTrials.gov record for NCT06084741, 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 26 Aug 2025.