Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

• Conditions: Surgery; Emergencies; Peptic Ulcer Perforation
• Interventions: Procedure: Simple repair or Graham technique

• Registration Number: NCT04447170
• Lead Sponsor: Gianluca Costa

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

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Primary Completion: 2021-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic repair	Simple repair or Graham technique	Patients undergoing laparoscopic treatment

Primary Outcome Measures

Name	Time	Method
30-day Mortality Rate	18 months
30-day Morbidity Rate	18 months	Morbidity defined by mean of the most used classification scoring system

Secondary Outcome Measures

Name	Time	Method
Operative time	18 months	The duration time of surgical step from in; The duration of the surgical procedure
Conversion rate	18 months	Defined when a procedure was attempted via the minimally invasive approach but required an open incision to be completed
Calculation of Boey index	18 months	Calculation and evaluation of its predictive value for morbidity and mortality
Calculation of Mannheim Peritonitis Index	18 months	Calculation and evaluation of its predictive value for morbidity and mortality
Calculation of Shock index	18 months	Calculation and evaluation of its predictive value for morbidity and mortality
Calculation of Age-related shock index	18 months	Calculation and evaluation of its predictive value for morbidity and mortality
Calculation of Charlson Age-Comorbidity Index (CACI)	18 months	Calculation and evaluation of its predictive value for morbidity and mortality

Trial Locations

Locations (13)

Ospedale San Giovanni Battista; 🇮🇹 Foligno, Umbria, Italy

Azienda Ospedaliera Santa Maria; 🇮🇹 Terni, Umbria, Italy

Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Emilia-Romagna, Italy

Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona; 🇮🇹 Ancona, Marche, Italy

Ospedale Civile di Adria; 🇮🇹 Adria, Rovigo, Italy

Policlinico San Pietro; 🇮🇹 Ponte San Pietro, Bergamo, Italy

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milano, Lombardia, Italy

Cagliari University Hospital Monserrato; 🇮🇹 Cagliari, Sardegna, Italy

Ospedale della Misericordia Grosseto; 🇮🇹 Grosseto, Toscana, Italy

Azienda Ospedaliera Pisana Policlinico Universitario Cisanello; 🇮🇹 Pisa, Toscana, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy

Azienda Ospedaliera San Camillo Forlanini di Roma; 🇮🇹 Roma, Lazio, Italy

Ospedale Cristo Re; 🇮🇹 Roma, Lazio, Italy