Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

Surgery Clinical Trial

— LOREPUP  

Official title:

Comparison Between Laparoscopic and Open Repair of Perforated Gastroduodenal Peptic Ulcer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04447170
• Other study ID #: I-Go-GIPS_2020_1
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: December 2021
• Source: University of Roma La Sapienza
• Contact: Gianluca Costa, MD, PhD
• Phone: 00393921119067
• Email: gianlucacostaphd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 relying on a propensity score matching statistical technique

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Peptic Ulcer
• Peptic Ulcer Perforation
• Surgery
• Ulcer

Intervention

Procedure:
• Simple repair or Graham technique
Simple suture with or without omental protective patch

Locations

Country	Name	City	State
Italy	Ospedale Civile di Adria	Adria	Rovigo
Italy	Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona	Ancona	Marche
Italy	Cagliari University Hospital Monserrato	Cagliari	Sardegna
Italy	Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara	Ferrara	Emilia-Romagna
Italy	Ospedale San Giovanni Battista	Foligno	Umbria
Italy	Ospedale della Misericordia Grosseto	Grosseto	Toscana
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Azienda Ospedaliera Pisana Policlinico Universitario Cisanello	Pisa	Toscana
Italy	Policlinico San Pietro	Ponte San Pietro	Bergamo
Italy	Azienda Ospedaliera San Camillo Forlanini di Roma	Roma	Lazio
Italy	Ospedale Cristo Re	Roma	Lazio
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome
Italy	Azienda Ospedaliera Santa Maria	Terni	Umbria

Sponsors (1)

Lead Sponsor	Collaborator
Gianluca Costa

Country where clinical trial is conducted

Italy, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day Mortality Rate		18 months
Primary	30-day Morbidity Rate	Morbidity defined by mean of the most used classification scoring system	18 months
Secondary	Conversion rate	Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed	18 months
Secondary	Calculation of Boey index	Calculation and evaluation of its predictive value for morbidity and mortality	18 months
Secondary	Calculation of Mannheim Peritonitis Index	Calculation and evaluation of its predictive value for morbidity and mortality	18 months
Secondary	Calculation of Shock index	Calculation and evaluation of its predictive value for morbidity and mortality	18 months
Secondary	Calculation of Age-related shock index	Calculation and evaluation of its predictive value for morbidity and mortality	18 months
Secondary	Operative time	The duration time of surgical step from in; The duration of the surgical procedure	18 months
Secondary	Calculation of Charlson Age-Comorbidity Index (CACI)	Calculation and evaluation of its predictive value for morbidity and mortality	18 months