NCT04447170

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

4.9 years

First QC Date

June 19, 2020

Last Update Submit

December 28, 2021

Conditions

SurgeryEmergenciesPeptic Ulcer Perforation

Keywords

Peptic ulcer perforationLaparoscopy

Outcome Measures

Primary Outcomes (2)

  • 30-day Mortality Rate

    18 months

  • 30-day Morbidity Rate

    Morbidity defined by mean of the most used classification scoring system

    18 months

Secondary Outcomes (7)

  • Conversion rate

    18 months

  • Calculation of Boey index

    18 months

  • Calculation of Mannheim Peritonitis Index

    18 months

  • Calculation of Shock index

    18 months

  • Calculation of Age-related shock index

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Laparoscopic repair

Patients undergoing laparoscopic treatment

Procedure: Simple repair or Graham technique

Open repair

Patients undergoing open treatment

Interventions

Simple repair or Graham techniquePROCEDURE

Simple suture with or without omental protective patch

Laparoscopic repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multicenter italian national case-control study

You may qualify if:

  • Patients surgically treated for benign peptic ulcer perforation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Policlinico San Pietro

Ponte San Pietro, Bergamo, Italy

RECRUITING

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

Ferrara, Emilia-Romagna, Italy

RECRUITING

Azienda Ospedaliera San Camillo Forlanini di Roma

Rome, Lazio, Italy

RECRUITING

Ospedale Cristo Re

Rome, Lazio, Italy

RECRUITING

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

RECRUITING

Ospedale Civile di Adria

Adria, Rovigo, Italy

RECRUITING

Cagliari University Hospital Monserrato

Cagliari, Sardinia, Italy

RECRUITING

Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona

Ancona, The Marches, 60121, Italy

RECRUITING

Ospedale della Misericordia Grosseto

Grosseto, Tuscany, 58100, Italy

RECRUITING

Azienda Ospedaliera Pisana Policlinico Universitario Cisanello

Pisa, Tuscany, 56121, Italy

RECRUITING

Ospedale San Giovanni Battista

Foligno, Umbria, 06034, Italy

RECRUITING

Azienda Ospedaliera Santa Maria

Terni, Umbria, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29659470BACKGROUND

  • 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.

    PMID: 26297055RESULT

  • 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.

    PMID: 27955872RESULT

MeSH Terms

Conditions

EmergenciesPeptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPeptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Central Study Contacts

Gianluca Costa, MD, PhD

CONTACT

00393921119067gianlucacostaphd@gmail.com

Pietro Fransvea, MD

CONTACT

00393289275731Pietro.fransvea@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 25, 2020

Study Start

January 1, 2017

Primary Completion

November 30, 2021

Study Completion

April 1, 2022

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

IT(13)