Clinical trial NCT04447170: Laparoscopic Versus Open Repair of Peptic Ulcer Perforation
Official title: Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Emergencies
Peptic Ulcer Perforation
Keywords: Peptic ulcer perforation
Laparoscopy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicenter italian national case-control study

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

Eligibility criteria: 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

Primary outcomes:
measure: 30-day Mortality Rate
timeFrame: 18 months
measure: 30-day Morbidity Rate
timeFrame: 18 months
Secondary outcomes:
measure: Conversion rate
timeFrame: 18 months
measure: Calculation of Boey index
timeFrame: 18 months
measure: Calculation of Mannheim Peritonitis Index
timeFrame: 18 months
measure: Calculation of Shock index
timeFrame: 18 months
measure: Calculation of Age-related shock index
timeFrame: 18 months
measure: Operative time
timeFrame: 18 months
measure: Calculation of Charlson Age-Comorbidity Index (CACI)
timeFrame: 18 months
Other outcomes:
Locations:
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
state: Bergamo
city: Ferrara
country: Italy
facility: Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini di Roma
state: Lazio
city: Roma
country: Italy
facility: Ospedale Cristo Re
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
state: Lombardia
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
state: Marche
city: Adria
country: Italy
facility: Ospedale Civile di Adria
state: Rovigo
city: Cagliari
country: Italy
facility: Cagliari University Hospital Monserrato
state: Sardegna
city: Grosseto
country: Italy
facility: Ospedale della Misericordia Grosseto
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
state: Toscana
city: Foligno
country: Italy
facility: Ospedale San Giovanni Battista
state: Umbria
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
state: Umbria
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.