Laparoscopic Versus Open Repair of Peptic Ulcer Perforation
NCT ID: NCT04447170
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-01-01
2022-04-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Laparoscopic repair
Patients undergoing laparoscopic treatment
Simple repair or Graham technique
Simple suture with or without omental protective patch
Open repair
Patients undergoing open treatment
No interventions assigned to this group
Interventions
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Simple repair or Graham technique
Simple suture with or without omental protective patch
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant and breastfeeding women
* Malignant ulcer perforation
* Gastric resection
* Diagnostic laparoscopy/laparotomy with no further surgical procedures performed
18 Years
ALL
No
Sponsors
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Gianluca Costa
OTHER
Responsible Party
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Gianluca Costa
Professor
Locations
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Policlinico San Pietro
Ponte San Pietro, Bergamo, Italy
Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini di Roma
Rome, Lazio, Italy
Ospedale Cristo Re
Rome, Lazio, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale Civile di Adria
Adria, Rovigo, Italy
Cagliari University Hospital Monserrato
Cagliari, Sardinia, Italy
Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
Ancona, The Marches, Italy
Ospedale della Misericordia Grosseto
Grosseto, Tuscany, Italy
Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
Pisa, Tuscany, Italy
Ospedale San Giovanni Battista
Foligno, Umbria, Italy
Azienda Ospedaliera Santa Maria
Terni, Umbria, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Mauro Montuori, MD
Role: primary
Savino Occhionorelli, MD
Role: primary
Pierluigi Marini, MD
Role: primary
Antonio Crucitti, MD
Role: primary
Giorgio Rossi, MD
Role: primary
Ferdinando Agresta, MD
Role: primary
Adolfo Pisanu, Prof.
Role: primary
Paolo Ruscelli, MD
Role: primary
Paolo Pietro Bianchi, MD
Role: primary
Massimo Chiarugi, MD
Role: primary
Graziano Ceccarelli, MD
Role: primary
Nicola Avenia, MD
Role: primary
Pietro Fransvea
Role: primary
References
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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.
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.
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.
Other Identifiers
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I-Go-GIPS_2020_1
Identifier Type: -
Identifier Source: org_study_id