ERAS in Colorectal Surgery: Benefits of Late Adoption

NCT05773248 | Completed

• 1 other identifier: 2023-00221
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this single-center retrospective cohort study is to explore the effect of late adaptation of an ERAS protocol in a high-volume colorectal surgical unit. The primary endpoint is the surgical outcome measured by early postoperative complications, defined by the comprehensive complications index. Secondary endpoints include amongst others LOS (length of stay), cost analysis, short-term follow-up in the ERAS group.

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• Perioperative morbidity

  Postoperative complications according to the comprehensive complication index (CCI)

  30days

Secondary Outcomes (3)

• Length of stay

  30 days up to 3 months

• Cost analysis

  30 days up to 3 months

• Readmission rate

  30 days

Study Arms (2)

Standard care

ERAS

Procedure: ERAS protocol

Interventions

ERAS protocol PROCEDURE

The main concepts of the ERAS protocol compared to standard care included the following aspects: preoperative counselling with a specially trained nurse, restrictive use of preoperative sedation, intraoperative fluid and opioid administration and drain placement, strict antiemetic prophylaxis, early mobilisation, bowel stimulation and removal of any catheters as well as early food intake. Additionally, the ERAS protocol included a 30-day telephone follow-up.

ERAS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing a colorectal procedure between 2019 and August 2022 at colorectal unit, Santa Clara Hospital, Basel

You may qualify if:

• written general informed consent
• patients undergoing a colorectal procedure between 2019 and August 2022 at colorectal unit, Santa Clara Hospital, Basel

You may not qualify if:

• All patients undergoing an emergency procedure or a combined procedure with the colorectal procedure not being the main indication for surgical treatment (i.e. gynecological debulking, liver resection, etc.) were excluded from the analysis.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St. Clara Hospital

Basel, 4058, Switzerland

Location

Related Publications (1)

• Susstrunk J, Mijnssen R, von Strauss M, Muller BP, Wilhelm A, Steinemann DC. Enhanced recovery after surgery (ERAS) in colorectal surgery: implementation is still beneficial despite modern surgical and anesthetic care. Langenbecks Arch Surg. 2023 Dec 13;409(1):5. doi: 10.1007/s00423-023-03195-7.

  PMID: 38091109 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daniel Steinemann, PD Dr.

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 17, 2023
• Study Start: March 13, 2023
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)