ERAS Program Items Adherence, PROMs and RIOT After Colorectal Surgery

NCT04397627 | Unknown

• 1 other identifier: iCral3
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 8

Brief Summary

Prospective multicenter observational no-profit study evaluating the impact of ERAS program items adherence rates on patient-reported outcomes (PRO) and return to intendend oncologic therapy (RIOT) after colorectal resection. Prospective enrollment from November 2020 to October 2021 in 60 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent. A total of 3,000 patients is expected based on a mean of 50 cases per center.

Conditions

Colorectal Surgery; Enhanced Recovery After Surgery; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (4)

• Change in patient-reported outcome measure #1; Health Questionnaire; Euro-QoL Group EQ-5D-5L™;

  Quality of life questionnaire based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scores ranging from 5 (worst) to 125 (best)

  Before the operation, postoperative day 5, 4 to 6 weeks after the operation

• Change in patient-reported outcome measure #2; Health Questionnaire: MD Anderson Symptom Inventory for gastrointestinal surgery patients (MDASI-GI)

  Specific quality of life questionnaire for patients submitted to GI surgery: based on 24 questions with scores ranging from 0 (best) to 10 (worst); total score from 0 (best) to 240 (worst)

  Before the operation, postoperative day 5, 4 to 6 weeks after the operation

• Change in patient-reported outcome measure #3; Health Questionnaire Functional Assessment of Cancer Therapy - Colorectal® (FACT-C)

  Specific quality of life questionnaire for patients with colorectal cancer. Scores ranging form 0 (worst) to 144 (best).

  Before the operation, postoperative day 5, 4 to 6 weeks after the operation

• Return to intended oncologic therapy (RIOT)

  Number of patients eligible for adjuvant therapy after surgery for colorectal cancer that receive appropriate treatment starting within 8 weeks after the operation

  8 weeks after the operation

Secondary Outcomes (4)

• Anastomotic leakage rate

  within 8 weeks from operation

• Overall morbidity rate

  within 8 weeks from operation

• Major morbidity rate

  within 8 weeks from operation

• Length of hospital stay (LOS)

  within 8 weeks from operation

Interventions

Colorectal resection PROCEDURE

All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent.

You may qualify if:

• Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis, including planned Hartmann's reversals.
• American Society of Anesthesiologists' (ASA) class I, II or III
• Elective or delayed urgency surgery
• Patients' written acceptance to be included in the study.

You may not qualify if:

• American Society of Anesthesiologists' (ASA) class IV-V
• Emergent surgery
• Pregnancy
• Hyperthermic intraperitoneal chemotherapy for carcinomatosis.

Sponsors & Collaborators

• Ospedale C & G Mazzoni: lead

Study Sites (8)

UOC Chirurgia Generale Universitaria - Ospedale San Salvatore - L'Aquila

L’Aquila, AQ, Italy

Location

S.C. Chirurgia Generale e Oncologica - Azienda Ospedaliera S. Croce e Carle - Cuneo, Italia

Cuneo, CN, 12100, Italy

Location

UOC Chirurgia Generale ad Indirizzo Oncologico - IRCCS San Martino IST - Genova

Genova, GE, 16121, Italy

Location

UOC Chirurgia Generale - Ospedale di Esine (BS) - ASST Valcamonica

Esine, NS, Italy

Location

UOC Chirurgia Generale e D'Urgenza . Azienda Ospedaliera San Camillo Forlanini Roma

Roma, RM, Italy

Location

UOC Chirurgia Generale - Ospedale Sacro Cuore Don Calabria Negrar Verona

Negrar, VR, 37024, Italy

Location

U.O.C. di Chirurgia Generale e dell'Esofago e Stomaco - AOUI di Verona

Verona, VR, Italy

Location

SOC Chirurgia Colorettale - Istituto Nazionale dei Tumori - IRCCS Fondazione "G.Pascale" - Napoli

Napoli, 80100, Italy

Location

Related Publications (4)

• Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

  PMID: 15896435 BACKGROUND

• Kehlet H. Fast-track colorectal surgery. Lancet. 2008 Mar 8;371(9615):791-3. doi: 10.1016/S0140-6736(08)60357-8. No abstract available.

  PMID: 18328911 BACKGROUND

• Aloia TA, Zimmitti G, Conrad C, Gottumukalla V, Kopetz S, Vauthey JN. Return to intended oncologic treatment (RIOT): a novel metric for evaluating the quality of oncosurgical therapy for malignancy. J Surg Oncol. 2014 Aug;110(2):107-14. doi: 10.1002/jso.23626. Epub 2014 May 21.

  PMID: 24846705 BACKGROUND

• Italian ColoRectal Anastomotic Leakage (iCral) Study Group. Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis. BJS Open. 2020 Jun;4(3):499-507. doi: 10.1002/bjs5.50269. Epub 2020 Mar 5.

  PMID: 32134216 BACKGROUND

Study Officials

• Marco Catarci, MD, FACS

  Ospedale CG Mazzoni Ascoli Piceno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Catarci, MD, FACS

CONTACT

3298610040; marco.catarci@sanita.marche.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACS; Director, General Surgery Unit

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 21, 2020
• Study Start: November 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

IT (8)