Textbook Outcome in Distal Pancreatectomy

NCT05423288 | Completed

• 1 other identifier: UE-CHUB-002-2022
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

The auditing of results and improving the quality of care are key aspects of surgical activity. Patients, hospitals and health institutions need information on the results obtained with specific procedures. The most commonly used method to assess quality of care is the measurement of postoperative complications, hospital stay, and readmission rates. Other assessment tools such as benchmarking allow comparisons to be made between centers. In 2013, Kolfschoten et al. introduced a new measure called textbook outcome (TO), a single indicator that combines several traditional care measures: the absence of postoperative complications, no prolongation of hospital stay (\< 75th percentile), no mortality and no readmissions. All these parameters must be fulfilled in order to achieve textbook outcome (TO). The investigators analyze the achievement of TO in a multicenter DP database using a specific TO for distal pancreatectomy (DP) (TO-DP) which includes clinically-relevant pancreatic fistula (grade B/C).

Conditions

Distal Pancreatectomy

Outcome Measures

Primary Outcomes (3)

• Mortality

  No postoperative mortality within 90 days after surgical procedure

  90 days

• Morbidity

  No major complications within 90 days after surgical procedure

  90 days

• Re-admission

  No re-admissions within 90 days after surgical procedure

  90 days

Interventions

Distal pancreatectomy (DP) PROCEDURE

Any scheduled distal pancreatectomy performed for any diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated on distal pancreatectomy. The surgical approach was either open or laparoscopic, with or without spleen preservation

You may qualify if:

• Any distal pancreatectomía performed for any diagnosis

You may not qualify if:

• Distal pancreatectomy with celiac trunk resection

Sponsors & Collaborators

• Universidad de Extremadura: lead

Related Publications (4)

• 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.

  PMID: 33961716 BACKGROUND

• Ramia JM, Soria-Aledo V. Textbook outcome: A new quality tool. Cir Esp (Engl Ed). 2021 Jul 6:S0009-739X(21)00215-3. doi: 10.1016/j.ciresp.2021.06.002. Online ahead of print. No abstract available. English, Spanish.

  PMID: 34243935 BACKGROUND

• de la Plaza Llamas R, Ramia Angel JM, Bellon JM, Arteaga Peralta V, Garcia Amador C, Lopez Marcano AJ, Medina Velasco AA, Gonzalez Sierra B, Manuel Vazquez 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.

  PMID: 30303875 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

Study Officials

• Gerardo Blanco-Fernández, MD, PhD

  Universidad de Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 21, 2022
• Study Start: January 1, 2008
• Primary Completion: December 31, 2018
• Study Completion: April 30, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share