Laparoscopic Versus Open Repair of Peptic Ulcer Perforation (LOREPUP)

Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer

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

Study Overview

• Status: Recruiting
• Conditions: Emergencies; Surgery; Peptic Ulcer Perforation
• Intervention / Treatment: Procedure: Simple repair or Graham 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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Gianluca Costa, MD, PhD; Phone Number: 00393921119067; Email: gianlucacostaphd@gmail.com
• Study Contact Backup: Name: Pietro Fransvea, MD; Phone Number: 00393289275731; Email: Pietro.fransvea@gmail.com

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Pietro Fransvea
    • Principal Investigator: Pietro Fransvea
  • Bergamo
    • Ponte San Pietro, Bergamo, Italy
      • Recruiting
      • Policlinico San Pietro
      • Contact: Mauro Montuori, MD
      • Principal Investigator: Enrico Pinotti, MD
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy
      • Recruiting
      • Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara
      • Contact: Savino Occhionorelli, MD
      • Principal Investigator: Savino Occhionorelli, MD
  • Lazio
    • Roma, Lazio, Italy
      • Recruiting
      • Azienda Ospedaliera San Camillo Forlanini di Roma
      • Contact: Pierluigi Marini, MD
      • Principal Investigator: Pietro Fransvea, MD
    • Roma, Lazio, Italy
      • Recruiting
      • Ospedale Cristo Re
      • Contact: Antonio Crucitti, MD
      • Principal Investigator: Casimiro Nigro, MD
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Recruiting
      • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
      • Contact: Giorgio Rossi, MD
      • Principal Investigator: Tiberio Canini, MD
  • Marche
    • Ancona, Marche, Italy, 60121
      • Recruiting
      • Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
      • Contact: Paolo Ruscelli, MD
      • Principal Investigator: Pietro Coletta, MD
  • Rovigo
    • Adria, Rovigo, Italy
      • Recruiting
      • Ospedale Civile di Adria
      • Contact: Ferdinando Agresta, MD
      • Principal Investigator: Elena Finotti, MD
  • Sardegna
    • Cagliari, Sardegna, Italy
      • Recruiting
      • Cagliari University Hospital Monserrato
      • Contact: Adolfo Pisanu, Prof.
      • Principal Investigator: Mauro Podda, MD
  • Toscana
    • Grosseto, Toscana, Italy, 58100
      • Recruiting
      • Ospedale della Misericordia Grosseto
      • Contact: Paolo Pietro Bianchi, MD
      • Principal Investigator: Martina De Luca, MD
    • Pisa, Toscana, Italy, 56121
      • Recruiting
      • Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
      • Contact: Massimo Chiarugi, MD
      • Principal Investigator: Dario Tartaglia, MD
  • Umbria
    • Foligno, Umbria, Italy, 06034
      • Recruiting
      • Ospedale San Giovanni Battista
      • Contact: Graziano Ceccarelli, MD
    • Terni, Umbria, Italy
      • Recruiting
      • Azienda Ospedaliera Santa Maria
      • Contact: Nicola Avenia, MD
      • Principal Investigator: Fabio Rondelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multicenter italian national case-control study

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic repair; Patients undergoing laparoscopic treatment	Procedure: Simple repair or Graham technique; Simple suture with or without omental protective patch
Open repair; Patients undergoing open treatment

What is the study measuring?

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
Calculation of Charlson Age-Comorbidity Index (CACI)	Calculation and evaluation of its predictive value for morbidity and mortality	18 months
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

Collaborators and Investigators

• Sponsor: Gianluca Costa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 30, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopy; Peptic ulcer perforation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Emergencies; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: I-Go-GIPS_2020_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No