Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation

NCT ID: NCT06870604

Last Updated: 2025-03-11

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

Total Enrollment

827 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2024-01-01

Brief Summary

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

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.

Detailed Description

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

Conditions

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

Gastric Perforation

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

the gastric perforation group

patients diagnosed as gastric perforation

do open surgery

Intervention Type PROCEDURE

Open surgery was performed in patients undergoing gastric perforation

do laparoscopic surgery

Intervention Type PROCEDURE

Laparoscopic surgery was performed in patients undergoing gastric perforation

Interventions

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

do open surgery

Open surgery was performed in patients undergoing gastric perforation

Intervention Type PROCEDURE

do laparoscopic surgery

Laparoscopic surgery was performed in patients undergoing gastric perforation

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* age ≥18 years;
* patients diagnosed with gastric perforation.

Exclusion Criteria

* patients with incomplete clinical data;
* laparoscopic surgery transfer to open surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Dong Peng

OTHER

Sponsor Role lead

Responsible Party

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

Dong Peng

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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

ZZ2025-131-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Peptic Ulcer Perforation Study
NCT00624169 COMPLETED NA
Damage Control Laparotomy
NCT02706041 COMPLETED NA