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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic repair | Patients undergoing laparoscopic treatment |
| |
| Open repair | Patients undergoing open treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple repair or Graham technique | Procedure | Simple suture with or without omental protective patch |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Multicenter italian national case-control study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianluca Costa, MD, PhD | Contact | 00393921119067 | gianlucacostaphd@gmail.com | |
| Pietro Fransvea, MD | Contact | 00393289275731 | Pietro.fransvea@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico San Pietro | Recruiting | Ponte San Pietro | Bergamo | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29659470 | Background | Cirocchi R, Soreide K, Di Saverio S, Rossi E, Arezzo A, Zago M, Abraha I, Vettoretto N, Chiarugi M. Meta-analysis of perioperative outcomes of acute laparoscopic versus open repair of perforated gastroduodenal ulcers. J Trauma Acute Care Surg. 2018 Aug;85(2):417-425. doi: 10.1097/TA.0000000000001925. | |
| 26297055 | Result |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| D010439 | Peptic Ulcer Perforation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010437 | Peptic Ulcer |
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| 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 |
| Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara | Recruiting | Ferrara | Emilia-Romagna | Italy |
|
| Azienda Ospedaliera San Camillo Forlanini di Roma | Recruiting | Rome | Lazio | Italy |
|
| Ospedale Cristo Re | Recruiting | Rome | Lazio | Italy |
|
| Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico | Recruiting | Milan | Lombardy | 20122 | Italy |
|
| Ospedale Civile di Adria | Recruiting | Adria | Rovigo | Italy |
|
| Cagliari University Hospital Monserrato | Recruiting | Cagliari | Sardinia | Italy |
|
| Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona | Recruiting | Ancona | The Marches | 60121 | Italy |
|
| Ospedale della Misericordia Grosseto | Recruiting | Grosseto | Tuscany | 58100 | Italy |
|
| Azienda Ospedaliera Pisana Policlinico Universitario Cisanello | Recruiting | Pisa | Tuscany | 56121 | Italy |
|
| Ospedale San Giovanni Battista | Recruiting | Foligno | Umbria | 06034 | Italy |
|
| Azienda Ospedaliera Santa Maria | Recruiting | Terni | Umbria | Italy |
|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Rome | Italy |
|
| Ge B, Wu M, Chen Q, Chen Q, Lin R, Liu L, Huang Q. A prospective randomized controlled trial of laparoscopic repair versus open repair for perforated peptic ulcers. Surgery. 2016 Feb;159(2):451-8. doi: 10.1016/j.surg.2015.07.021. Epub 2015 Aug 19. |
| 27955872 | Result | Siow SL, Mahendran HA, Wong CM, Hardin M, Luk TL. Laparoscopic versus open repair of perforated peptic ulcer: Improving outcomes utilizing a standardized technique. Asian J Surg. 2018 Mar;41(2):136-142. doi: 10.1016/j.asjsur.2016.11.004. Epub 2016 Dec 7. |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |