Gastric PerforationNCT06870604
Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation
An observational study of Gastric Perforation, run by Dong Peng.
Trial summary
Gastric perforation (GP) is a penetrating lesion of the gastric wall that accounts for 10-15% of all peptic ulcer perforations, and most GP are spontaneous perforations caused by ulcer disease. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gastric Perforation
- What is being tested?
- do open surgery and do laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 827 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2024
- Phase
- Observational
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with gastric perforation
Who may be able to join
- age ≥18 years;
- patients diagnosed with gastric perforation.
Who cannot join
- patients with incomplete clinical data;
- laparoscopic surgery transfer to open surgery.
About this study
Official title: Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation: a Multicenter, Propensity Score-matched Analysis
Gastric perforation (GP) is a penetrating lesion of the gastric wall that accounts for 10-15% of all peptic ulcer perforations, and most GP are spontaneous perforations caused by ulcer disease. Due to the presence of gastric acid, most patients often present to the emergency department with severe abdominal or chest pain due to chemical peritonitis within a few hours of perforation. Emergency physicians often quickly diagnose GP by using a chest x-ray or CT in an upright position and the patient's symptoms. Studies have shown that about 80-85% of patients with GP had subphrenic free gas visible on x-ray in the upright position.
Surgery is currently the mainstay of treatment for most GP, and almost all cases require urgent surgical repair.2 Over the past few years, laparoscopic surgery has become increasingly popular in clinical practice due to its advantages of less pain, less scarring, and early mobility out of bed, and has become the standard treatment for many elective and emergency procedures.
Since the laparoscopic study of PPU was first published by Mouret P in 1990, investigators have launched extensive discussions on the effects of laparoscopic surgery and open surgery in patients with perforated ulcers. However, to our knowledge, there are few separate discussions on GP, and the postoperative prognosis of laparoscopic surgery for patients with GP is less clear. Therefore, the aim of this multicenter, large-scale retrospective study was to compare the clinical outcomes of laparoscopic surgery and open surgery in patients with GP, to investigate whether laparoscopic surgery is safe and feasible for patients with GP, and to provide reliable evidence for surgical strategies in patients with GP.
- Conditions
- Gastric Perforation
- Being tested
- do open surgery, do laparoscopic surgery
- Keywords
- gastric perforation, laparoscopic surgery, open surgery, PSM, overall complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
do open surgeryProcedure or surgery
Open surgery was performed in patients undergoing gastric perforation
do laparoscopic surgeryProcedure or surgery
Laparoscopic surgery was performed in patients undergoing gastric perforation
| Study group | Role | What they receive |
|---|---|---|
| the gastric perforation group | patients diagnosed as gastric perforation Receives: Procedure: do open surgery; Procedure: do laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival (OS) was described as time from date of diagnosis until the date of death from any cause or or loss to follow-up.
Measured: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2013
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870604
- Sponsor's protocol ID
- ZZ2025-131-01
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical centres conducting this study are not allowed to disclose patient information and data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation: a Multicenter, Propensity Score-matched Analysis
- ClinicalTrials.gov ID
- NCT06870604
- Acronym / sponsor ID
- ZZ2025-131-01
- Conditions
- Gastric Perforation
- Keywords
- gastric perforation, laparoscopic surgery, open surgery, PSM, overall complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 827 participants (actual)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 11 Mar 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.
Gastric perforation (GP) is a penetrating lesion of the gastric wall that accounts for 10-15% of all peptic ulcer perforations, and most GP are spontaneous perforations caused by ulcer disease. Due to the presence of gastric acid, most patients often present to the emergency department with severe abdominal or chest pain due to chemical peritonitis within a few hours of perforation. Emergency physicians often quickly diagnose GP by using a chest x-ray or CT in an upright position and the patient's symptoms. Studies have shown that about 80-85% of patients with GP had subphrenic free gas visible on x-ray in the upright position.
Surgery is currently the mainstay of treatment for most GP, and almost all cases require urgent surgical repair.2 Over the past few years, laparoscopic surgery has become increasingly popular in clinical practice due to its advantages of less pain, less scarring, and early mobility out of bed, and has become the standard treatment for many elective and emergency procedures.
Since the laparoscopic study of PPU was first published by Mouret P in 1990, investigators have launched extensive discussions on the effects of laparoscopic surgery and open surgery in patients with perforated ulcers. However, to our knowledge, there are few separate discussions on GP, and the postoperative prognosis of laparoscopic surgery for patients with GP is less clear. Therefore, the aim of this multicenter, large-scale retrospective study was to compare the clinical outcomes of laparoscopic surgery and open surgery in patients with GP, to investigate whether laparoscopic surgery is safe and feasible for patients with GP, and to provide reliable evidence for surgical strategies in patients with GP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the gastric perforation group | – | Procedure: do open surgery, Procedure: do laparoscopic surgerypatients diagnosed as gastric perforation |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with gastric perforation
Key inclusion criteria (2 listed)
- age ≥18 years;
- patients diagnosed with gastric perforation.
Key exclusion criteria (2 listed)
- patients with incomplete clinical data;
- laparoscopic surgery transfer to open surgery.
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 |
|---|---|---|
| do open surgeryOpen surgery was performed in patients undergoing gastric perforation | Procedure or surgery | the gastric perforation group |
| do laparoscopic surgeryLaparoscopic surgery was performed in patients undergoing gastric perforation | Procedure or surgery | the gastric perforation group |
Primary outcome
overall survival
Time frame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.
Overall survival (OS) was described as time from date of diagnosis until the date of death from any cause or or loss to follow-up.
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 11 Mar 2025.
- Individual participant dataSharing planned: No. Clinical centres conducting this study are not allowed to disclose patient information and data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Perforation, run by Dong Peng.
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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
overall survival (time frame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.). 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 11 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.