Emergencies, Peptic Ulcer Perforation, Surgery
Conditions
Keywords
Peptic ulcer perforation, Laparoscopy
Brief 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
Interventions
PROCEDURESimple repair or Graham technique
Simple suture with or without omental protective patch
Sponsors
Gianluca Costa
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients surgically treated for benign peptic ulcer perforation
Exclusion criteria
* Age \< 18 years * Pregnant and breastfeeding women * Malignant ulcer perforation * Gastric resection * Diagnostic laparoscopy/laparotomy with no further surgical procedures performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Mortality Rate | 18 months | — |
| 30-day Morbidity Rate | 18 months | Morbidity defined by mean of the most used classification scoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calculation of Mannheim Peritonitis Index | 18 months | Calculation and evaluation of its predictive value for morbidity and mortality |
| Calculation of Shock index | 18 months | Calculation and evaluation of its predictive value for morbidity and mortality |
| Conversion rate | 18 months | Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed |
| Operative time | 18 months | The duration time of surgical step from in The duration of the surgical procedure |
| Calculation of Charlson Age-Comorbidity Index (CACI) | 18 months | Calculation and evaluation of its predictive value for morbidity and mortality |
| Calculation of Age-related shock index | 18 months | Calculation and evaluation of its predictive value for morbidity and mortality |
| Calculation of Boey index | 18 months | Calculation and evaluation of its predictive value for morbidity and mortality |
Countries
Italy
Contacts
Primary ContactGianluca Costa, MD, PhD
Backup ContactPietro Fransvea, MD
Outcome results
None listed