Enhanced Recovery and Patient Blood Management in Colorectal Surgery

NCT05227014 | Unknown

• 1 other identifier: iCral4
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes after colorectal surgery

Conditions

Anastomotic Leak; Colorectal Neoplasms; Blood Transfusion Complication; Colorectal Disorders

Keywords

PBM; ERAS

Outcome Measures

Primary Outcomes (3)

• Anastomotic leakage rate

  number of patient with anastomotic leakage

  within 8 weeks from the operation

• Major morbidity rate

  number of patient with any Clavien-Dindo grade \> II adverse event

  within 8 weeks from the operation

• Transfusion rate

  number of patient receiving at least one unit of packed red blood cells

  from 4 weeks before to 8 weeks after the operation

Secondary Outcomes (4)

• Overall morbidity rate

  within 8 weeks from the operation

• Length of Postoperative Hospital Stay (LOS)

  within 8 weeks from the operation

• Number of transfused blood units

  from 4 weeks before to 8 weeks after the operation

• Postoperative hemoglobin values

  4 days after the operation, at discharge, 6 weeks after the operation

Interventions

Colorectal resection PROCEDURE

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

Also known as: Colectomy, proctectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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, III or IV
• Elective or delayed urgency (\> 24 hours from admission) surgery
• Patients' written acceptance to be included in the study.

You may not qualify if:

• American Society of Anesthesiologists' (ASA) class V
• Emergent surgery (≤ 24 hours from admission)
• Pregnancy
• Hyperthermic intraperitoneal chemotherapy for carcinomatosis.

Sponsors & Collaborators

• Ospedale Sandro Pertini, Roma: lead
• Associazione Chirurghi Ospedalieri Italiani: collaborator

Study Sites (1)

Ospedale Sandro Pertini

Roma, RM, 00157, Italy

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak; Colorectal Neoplasms; Transfusion Reaction

Interventions

Colectomy; Proctectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Marco Catarci, MD, FACS

CONTACT

+393298610040; marco.catarci@aslroma2.it

Study Design

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

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)