NCT04447170

Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Gianluca Costa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Although laparoscopic repair (LR) of perforated peptic ulcers (PPUs) has long been accepted, clinical evidence comparing LR versus open repair (OR) remains lacking. The aim of this study is to evaluate the feasibility, safety and outcome of laparoscopic gastric repair and compare it with the outcome open repair by relying on a propensity score matching statistical technique

Detailed description

Despite the evolution of medical management of Gastroduodenal Peptic Ulcer (GPU), complications like bleeding and perforation are still not uncommon in clinical practice. According to the literature in average, 2-14% of peptic ulcers result in perforation, most 215 commonly occurring in females over the age of 60 and chronic NSAID, alcohol or tobacco users. Management of perforated peptic ulcer entails resuscitation, pharmacotherapy and surgery. Traditionally, suture with or without omental patch has been considered the 'gold standard' and still is. It is associated with shorter length of stay, lower transfusion needs and has lower morbidity as compared to gastrectomy. In 1992, it has been proposed that laparoscopy should be routinely considered in the management of perforated duodenal ulcer. Nowadays due to the advances in laparoscopic technique, many publications suggest that laparoscopic repair of perforated peptic ulcers could be a superior choice to open repair. These is linked with the advantages of laparoscopic surgery over open surgery such as reduced postoperative pain, lower wound infection rate, decreased length of hospital stay, and earlier functional recovery

Conditions

• Surgery
• Emergencies
• Peptic Ulcer Perforation

Interventions

Type	Name	Description
PROCEDURE	Simple repair or Graham technique	Simple suture with or without omental protective patch

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-11-30
• Completion: 2022-04-01
• First posted: 2020-06-25
• Last updated: 2021-12-29

Locations

13 sites across 1 country: Italy