AzTrials
AzTrials

SurgeryLOREPUPNCT04447170

Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

An observational study of Surgery and Emergencies, run by Gianluca Costa at 13 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery, Emergencies, Peptic Ulcer Perforation
What is being tested?
Simple repair or Graham technique
Type of treatment
Surgery or procedure
How many people
200 participants
Where
13 sitesItaly
Study dates
1 Jan 2017to 1 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Multicenter italian national case-control study

Who may be able to join

  • Patients surgically treated for benign peptic ulcer perforation

Who cannot join

  • Age < 18 years
  • Pregnant and breastfeeding women
  • Malignant ulcer perforation
  • Gastric resection
  • Diagnostic laparoscopy/laparotomy with no further surgical procedures performed

Trial locations and contacts

13 sites in 1 country.

Gianluca Costa, MD, PhD contact

00393921119067

gianlucacostaphd@gmail.com

Pietro Fransvea, MD contact

00393289275731

Pietro.fransvea@gmail.com

13 sites in 1 country

Italy13 sites, 13 recruiting

  • Ospedale Civile di Adria

    Adria, Rovigo

    Ferdinando Agresta, MD

    Elena Finotti, MD

    Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona

    Ancona, The Marches, 60121

    Paolo Ruscelli, MD

    Pietro Coletta, MD

    Recruiting

  • Cagliari University Hospital Monserrato

    Cagliari, Sardinia

    Adolfo Pisanu, Prof.

    Mauro Podda, MD

    Recruiting

  • Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara, Emilia-Romagna

    Savino Occhionorelli, MD

    Savino Occhionorelli, MD

    Recruiting

  • Ospedale San Giovanni Battista

    Foligno, Umbria, 06034

    Graziano Ceccarelli, MD

    Recruiting

  • Ospedale della Misericordia Grosseto

    Grosseto, Tuscany, 58100

    Paolo Pietro Bianchi, MD

    Martina De Luca, MD

    Recruiting

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

    Giorgio Rossi, MD

    Tiberio Canini, MD

    Recruiting

  • Azienda Ospedaliera Pisana Policlinico Universitario Cisanello

    Pisa, Tuscany, 56121

    Massimo Chiarugi, MD

    Dario Tartaglia, MD

    Recruiting

  • Policlinico San Pietro

    Ponte San Pietro, Bergamo

    Mauro Montuori, MD

    Enrico Pinotti, MD

    Recruiting

  • Azienda Ospedaliera San Camillo Forlanini di Roma

    Rome, Lazio

    Pierluigi Marini, MD

    Pietro Fransvea, MD

    Recruiting

  • Ospedale Cristo Re

    Rome, Lazio

    Antonio Crucitti, MD

    Casimiro Nigro, MD

    Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome

    Pietro Fransvea

    Pietro Fransvea

    Recruiting

  • Azienda Ospedaliera Santa Maria

    Terni, Umbria

    Nicola Avenia, MD

    Fabio Rondelli, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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

Read the 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

Being tested
Simple repair or Graham technique
Keywords
Peptic ulcer perforation, Laparoscopy
Medical subject headings
Emergencies, Peptic Ulcer Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simple repair or Graham techniqueProcedure or surgery

    Simple suture with or without omental protective patch

Study groups in NCT04447170
Study groupRoleWhat they receive
Laparoscopic repairPatients undergoing laparoscopic treatment
Receives: Procedure: Simple repair or Graham technique
Open repairPatients undergoing open treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day Mortality Rate

    Measured: 18 months

  2. 30-day Morbidity Rate

    Morbidity defined by mean of the most used classification scoring system

    Measured: 18 months

Secondary outcomes (7)

  1. Conversion rate

    Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed

    Measured: 18 months

  2. Calculation of Boey index

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 18 months

  3. Calculation of Mannheim Peritonitis Index

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 18 months

  4. Calculation of Shock index

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 18 months

  5. Calculation of Age-related shock index

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 18 months

  6. Operative time

    The duration time of surgical step from in

    The duration of the surgical procedure

    Measured: 18 months

  7. Calculation of Charlson Age-Comorbidity Index (CACI)

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start1 Jan 2017
  3. Primary completion30 Nov 2021
  4. Study completion1 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447170
Sponsor's protocol ID
I-Go-GIPS_2020_1
Acronym
LOREPUP
Status last verified
Dec 2021
First submitted
19 Jun 2020
Last updated
29 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29659470

  • 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.

    PubMed 26297055

  • 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.

    PubMed 27955872

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Emergencies, run by Gianluca Costa at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gianluca Costa, MD, PhD (00393921119067, gianlucacostaphd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day Mortality Rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447170, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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