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

NCT06870604 | Completed DMC

• 1 other identifier: ZZ2025-131-01
• Study Type: observational
• Target: 827
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

gastric perforation; laparoscopic surgery; open surgery; PSM; overall complications

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (1)

the gastric perforation group

patients diagnosed as gastric perforation

Procedure: do open surgery; Procedure: do laparoscopic surgery

Interventions

do open surgery PROCEDURE

Open surgery was performed in patients undergoing gastric perforation

the gastric perforation group

do laparoscopic surgery PROCEDURE

Laparoscopic surgery was performed in patients undergoing gastric perforation

the gastric perforation group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with gastric perforation

You may qualify if:

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

You may not qualify if:

• patients with incomplete clinical data;
• laparoscopic surgery transfer to open surgery.

Sponsors & Collaborators

• Dong Peng: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2013
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share