Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06369194
Other study ID # POWER5
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 14, 2023
Est. completion date April 15, 2024

Study information

Verified date April 2024
Source Grupo Español de Rehabilitación Multimodal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT). It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up. To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p <0.05 (two tails).


Description:

Study Data Five-year data will be collected from all eligible patients who have undergone elective colorectal surgery within the POWER1 protocol. Only routine clinical data will be included and, when not available, the field will be left blank, e.g., patients lost to follow-up. Regional groups may supplement their basic data set with a very limited number of additional variables. Data collection The data will be collected from CRFs collected in POWER1. The list of pseudo-anomized patients delivered at the time will be provided with the new variables to be completed by the centers. Variables Overall mortality: The number and percentage of deaths occurred since the intervention until the end of the follow-up period. Overall survival: patients alive from surgery to the last control. Disease-free survival: number of patients alive and without cancer recurrence from the intervention period until the end of follow-up. Disease recurrence: detected by CT or FCC, from the day of the intervention until the end of the follow-up. Date until start of adjuvant treatment: date between date of discharge and start of adjuvant treatment Satistica analyse All regional and institutional level data will be anonymised prior to publication. Continuous variables will be described as mean and standard deviation, if normally distributed, or median and inter-quartile range, if not normally distributed. Comparisons of continuous variables will be performed using one-way ANOVA or Mann-Whitney test as appropriate. Categorical variables will be described as proportions and will be compared using chi-square or Fisher's exact test. Single-level and hierarchical multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. Factors will be entered into the models based on their univariate relation to outcome (p<0.05), biological plausibility and low rate of missing data. A stepwise approach will be used to enter new terms. Results of logistic regression will be reported as adjusted odds ratios (OR) with 95% confidence intervals. The models will be assessed through the use of sensitivity analyses to explore possible interacting factors and examine any effect on the results. A single final analysis is planned at the end of the study. Survival analyzes will be performed using the Kaplan-Meier method for survival comparisons the log-rank test will be used. The effects will be considered significant if p <0.05. Monitoring and audit The data collection documents will be audited to ensure that study activities are carried out in accordance with the protocol, good clinical practice and applicable regulatory requirements. In the participating hospitals, local study documents can be selected for local auditing. The quality of the data will be audited. Limitations of the study Those of a prospective non-randomized study. Difficulty in recruiting patients for potential structural or multidisciplinary team problems. Inappropriate number of patients due loss of follow-up.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 847
Est. completion date April 15, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients over 18 years of age who underwent elective colorectal cancer surgery in POWER1 Exclusion Criteria: - Non oncological surgery, refusal of the centers to participate.

Study Design


Intervention

Procedure:
Colorectal Surgery
Postoperative Audit

Locations

Country Name City State
Spain Hospital Universitario Araba Alava
Spain Hospital Virgen de los Lirios de Alcoy Alcoy Alicante
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Clínic Universitat de Barcelona Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Santa Creu i Sant Pau Barcelona
Spain Hospital Universitario Vall d´Hebrón Barcelona
Spain Hospital General Universitario de Castellón Castellon de la Plana Castellón
Spain Hospital General Universitario de Ciudad Real Ciudad Real
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital de Galdakao-Usansolo Galdakao
Spain Hospital de Igualada Igualada Barcelona
Spain Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas
Spain Hospital Universitario Insular de Gran Canaria Las Palmas de Gran Canaria
Spain Hospital Universitario Rafael Méndez Lorca Murcia
Spain Hospital de La Princesa Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Universitario San Carlos Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
Spain Hospital Costa del Sol Marbella Málaga
Spain Hospital Universitario de Móstoles Mostoles Madrid
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Complejo Hospitalario de Salamanca Salamanca
Spain Hospital Universitario Donostia San Sebastián
Spain Hospital de Sant Joan Despí Moisès Broggi Sant Joan d'Espi Barcelona
Spain Fundación Hospital del Espíritu Santo Santa Coloma De Gramenet Barcelona
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Nuestra Señora del Prado Talavera de la Reina Toledo
Spain Hospital Universitari Mútua Terrassa Terrassa Barcelona
Spain Consorcio Hospital General Unidersitario de Valencia Valencia
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Hospital Clínico de Valladolid Valladolid
Spain Hospital Universitario de Vic Vic Barcelona
Spain Hospital Universitario Miguel Server Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Grupo Español de Rehabilitación Multimodal

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Patients alive from surgery to the last control 5 years
Primary Disease-free survival Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up 5 years
Primary Time to disease recurrence Detected from the day of the intervention until the end of follow-up 5 years
Primary Time to return to intended oncologic treatment (RIOT) Date between discharged and adjuvant treatment 5 years
See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Recruiting NCT03560180 - Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: Italian ColoRectal Anastomotic Leakage Study Group.
Completed NCT03357497 - Very Early Mobilization of Colorectal Surgery Patients N/A
Recruiting NCT02143336 - Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients N/A
Completed NCT02846285 - Causes of Low Digestive Bleeding in Proctology N/A
Completed NCT01547572 - Psychological Preparation for Colorectal Surgery: Impact of Video Education N/A
Completed NCT00867958 - Compression Anastomosis Using the CARâ„¢ 27 N/A
Completed NCT00731978 - NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial N/A
Terminated NCT00413127 - Perioperative Protective Effects of Lidocaine Phase 2/Phase 3
Recruiting NCT00498290 - The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery N/A
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Not yet recruiting NCT03814681 - Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
Completed NCT03012802 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Completed NCT03620851 - Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)
Completed NCT03922113 - Muscle Function After Intensive Care
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT02999217 - Intravenous Iron for Correction of Anaemia After Colorectal Surgery Phase 4
Completed NCT02543190 - System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program N/A
Completed NCT01220661 - Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery Phase 2
Recruiting NCT00773981 - Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection Phase 3