Omitting Drains After Repair of Peptic Ulcer Perforations

NCT ID: NCT06084741

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2024-03-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

. 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peptic Ulcer Perforations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drain group

In Group A the investigators will put intraabdominal drains

Group Type ACTIVE_COMPARATOR

Using intraabdominal drains

Intervention Type OTHER

The investigators will put intraabdominal drains

No drain group

The investigators will not put any intraabdominal drains

Group Type EXPERIMENTAL

Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations

Intervention Type OTHER

omitting the intraabdominal drains

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations

omitting the intraabdominal drains

Intervention Type OTHER

Using intraabdominal drains

The investigators will put intraabdominal drains

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed Elshwadfy Nageeb

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammed ElShwadfy

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38878063 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-79-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Damage Control Laparotomy
NCT02706041 COMPLETED NA
Registrar Performances in MIDP
NCT04429074 COMPLETED