Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

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Estado

Patrocinadores

Gianluca Costa

ENSAYO CLÍNICO: NCT04447170

BioSeek: nct04447170

Palabras clave

Abstracto

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

Descripción

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

fechas

Verificado por última vez:	05/31/2020
Primero enviado:	06/18/2020
Inscripción estimada enviada:	06/22/2020
Publicado por primera vez:	06/24/2020
Última actualización enviada:	06/22/2020
Última actualización publicada:	06/24/2020
Fecha de inicio real del estudio:	08/31/2020
Fecha estimada de finalización primaria:	12/30/2020
Fecha estimada de finalización del estudio:	08/31/2021

Condición o enfermedad

Surgery

Emergencies

Peptic Ulcer Perforation

Intervención / tratamiento

Procedure: Laparoscopic repair

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
Laparoscopic repair Patients undergoing laparoscopic treatment	Procedure: Laparoscopic repair Simple suture with or without omental protective patch
Open repair Patients undergoing open treatment

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Método de muestreo	Non-Probability Sample
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

1. 30-day Mortality Rate [18 months]

2. 30-day Morbidity Rate [18 months]

Morbidity defined by mean of the most used classification scoring system

Medidas de resultado secundarias

1. Conversion rate [18 months]

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

2. Calculation of Boey index [18 months]