Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer

Conditions
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Surgery, Emergencies, Peptic Ulcer Perforation

Intervention / Treatment
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* Procedure: Simple repair or Graham technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic repair<br>Patients undergoing laparoscopic treatment | Procedure: Simple repair or Graham technique<br>* Simple suture with or without omental protective patch<br>|
| Open repair<br>Patients undergoing open treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Mortality Rate |  | 18 months | 
| 30-day Morbidity Rate | Morbidity defined by mean of the most used classification scoring system | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed | 18 months | 
| Calculation of Boey index | Calculation and evaluation of its predictive value for morbidity and mortality | 18 months | 
| Calculation of Mannheim Peritonitis Index | Calculation and evaluation of its predictive value for morbidity and mortality | 18 months | 
| Calculation of Shock index | Calculation and evaluation of its predictive value for morbidity and mortality | 18 months | 
| Calculation of Age-related shock index | Calculation and evaluation of its predictive value for morbidity and mortality | 18 months | 
| Operative time | The duration time of surgical step from in The duration of the surgical procedure | 18 months | 
| Calculation of Charlson Age-Comorbidity Index (CACI) | Calculation and evaluation of its predictive value for morbidity and mortality | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer perforation, Laparoscopy