Surgical Treatment of Liver Hydatid Cyst (SURGHIDA)

Echinococcosis, Hepatic Clinical Trial

— SURGHIDA  

Official title:

Outcome After Surgical Treatment of Liver Hydatid Cyst

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420155
• Other study ID #: UE-CHUB-001-2022
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2022
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim was to analyses the incidence and the independent factors associated with Textbook Outcome following surgical treatment of liver hydatid cysts (LHC).

Description:

Textbook outcome (TO) is a composite measure to determine the ideal postoperative period and to assess the quality of surgical care. The aim was to analyses the incidence and the independent factors associated with TO following surgical treatment of liver hydatid cysts (LHC).

The investigators conducted a retrospective cohort study of patients operated on for hepatic hydatidosis between January 2006 to December 2021. TO occurred when all the following criteria were fulfilled: no mortality within 90 days, no major complications within 90 days, no reintervention within 90 days and no prolonged hospital stay. Univariable and multivariable analyses were performed to identify factors associated with TO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: May 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with liver hydatid cyst treated by total or partial pericystectomy

Exclusion Criteria:

• emergency surgery and simple drainage of cyst

Related Conditions & MeSH terms

• Echinococcosis, Hepatic

Intervention

Procedure:
• Surgical resection
Surgical treatment of hepatic hydatidic cyst

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Extremadura	Complejo Hospitalario Universitario de Badajoz

References & Publications (5)

de la Plaza Llamas R, Ramia Ángel JM, Bellón JM, Arteaga Peralta V, García Amador C, López Marcano AJ, Medina Velasco AA, González Sierra B, Manuel Vázquez A. Clinical Validation of the Comprehensive Complication Index as a Measure of Postoperative Morbidity at a Surgical Department: A Prospective Study. Ann Surg. 2018 Nov;268(5):838-844. doi: 10.1097/SLA.0000000000002839. — View Citation

Jaén-Torrejimeno I, López-Guerra D, Prada-Villaverde A, Blanco-Fernández G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26. — View Citation

Manterola C, Otzen T, Urrutia S; MINCIR Group (Methodology and Research in Surgery). Risk factors of postoperative morbidity in patients with uncomplicated liver hydatid cyst. Int J Surg. 2014;12(7):695-9. doi: 10.1016/j.ijsu.2014.05.063. Epub 2014 May 21. — View Citation

Mehta R, Tsilimigras DI, Pawlik TM. Assessment of Magnet status and Textbook Outcomes among medicare beneficiaries undergoing hepato-pancreatic surgery for cancer. J Surg Oncol. 2021 Sep;124(3):334-342. doi: 10.1002/jso.26521. Epub 2021 May 7. — View Citation

van Roessel S, Mackay TM, van Dieren S, van der Schelling GP, Nieuwenhuijs VB, Bosscha K, van der Harst E, van Dam RM, Liem MSL, Festen S, Stommel MWJ, Roos D, Wit F, Molenaar IQ, de Meijer VE, Kazemier G, de Hingh IHJT, van Santvoort HC, Bonsing BA, Busch OR, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Textbook Outcome: Nationwide Analysis of a Novel Quality Measure in Pancreatic Surgery. Ann Surg. 2020 Jan;271(1):155-162. doi: 10.1097/SLA.0000000000003451. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	no mortality within 90 days	90 days
Primary	Morbidity	no major complications within 90 days	90 days
Primary	Re-admission	no re-admissions within 90 days	90 days