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Laparoscopic Versus Open Repair of Peptic Ulcer Perforation (LOREPUP)

G

Gianluca Costa

Status

Unknown

Conditions

Emergencies
Surgery
Peptic Ulcer Perforation

Treatments

Procedure: Simple repair or Graham technique

Study type

Observational

Funder types

Other

Identifiers

NCT04447170
I-Go-GIPS_2020_1

Details and patient eligibility

About

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

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Laparoscopic repair
Description:
Patients undergoing laparoscopic treatment
Treatment:
Procedure: Simple repair or Graham technique
Open repair
Description:
Patients undergoing open treatment

Trial contacts and locations

13

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Central trial contact

Gianluca Costa, MD, PhD; Pietro Fransvea, MD

Data sourced from clinicaltrials.gov

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