Laparoscopic Versus Open Repair of Peptic Ulcer Perforation (LOREPUP)

December 28, 2021 updated by: Gianluca Costa

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
30-day Mortality Rate
Time Frame: 18 months
18 months
30-day Morbidity Rate
Time Frame: 18 months
Morbidity defined by mean of the most used classification scoring system
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Calculation of Charlson Age-Comorbidity Index (CACI)
Time Frame: 18 months
Calculation and evaluation of its predictive value for morbidity and mortality
18 months
Conversion rate
Time Frame: 18 months
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
Time Frame: 18 months
Calculation and evaluation of its predictive value for morbidity and mortality
18 months
Calculation of Mannheim Peritonitis Index
Time Frame: 18 months
Calculation and evaluation of its predictive value for morbidity and mortality
18 months
Calculation of Shock index
Time Frame: 18 months
Calculation and evaluation of its predictive value for morbidity and mortality
18 months
Calculation of Age-related shock index
Time Frame: 18 months
Calculation and evaluation of its predictive value for morbidity and mortality
18 months
Operative time
Time Frame: 18 months

The duration time of surgical step from in

The duration of the surgical procedure
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gianluca Costa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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