NCT07889934

Brief Summary

This study compared an Enhanced Recovery After Surgery (ERAS) care program with conventional perioperative care in adults undergoing surgery for colorectal cancer. Participants were randomly assigned to receive either ERAS care or usual care. The ERAS program included coordinated measures before, during, and after surgery aimed at supporting faster and safer recovery. The study evaluated whether ERAS could reduce the length of hospital stay and improve postoperative recovery. Other outcomes included early mobilization, return of bowel function and oral feeding, postoperative pain, complications and adverse events, removal of urinary catheters and drains, discontinuation of intravenous therapy, and selected laboratory measures. The study was conducted at the General Anticancer Oncology Hospital of Athens "Saint Savvas" in Greece.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2026

Completed
Last Updated

October 22, 2026

Status Verified

October 1, 2026

Enrollment Period

9 months

First QC Date

October 18, 2026

Last Update Submit

October 18, 2026

Conditions

Keywords

Enhanced Recovery After SurgeryERASColorectal CancerColorectal SurgeryPerioperative CarePostoperative RecoveryLength of StayPostoperative ComplicationsPostoperative PainEarly MobilizationBowel FunctionNursing Care

Outcome Measures

Primary Outcomes (1)

  • Postoperative Length of Hospital Stay

    Number of calendar days from the date of surgery to the date of hospital discharge, obtained from the hospital medical record. A shorter postoperative hospital stay indicates earlier discharge after colorectal cancer surgery.

    From the date of surgery to hospital discharge, up to approximately 14 days

Secondary Outcomes (9)

  • Time to First Postoperative Mobilization

    From surgery until first mobilization, assessed during the first postoperative day and thereafter if needed

  • Time to Full Postoperative Mobilization

    From surgery until full mobilization

  • Time to Return of Gastrointestinal Motility

    From surgery until return of gastrointestinal motility

  • Time to Postoperative Oral Feeding

    From surgery until resumption of oral feeding

  • Postoperative Pain Intensity

    0-2, 2-6, 6-12, and 12-24 hours after surgery; postoperative days 1, 2, and 3; and at hospital discharge

  • +4 more secondary outcomes

Other Outcomes (4)

  • Postoperative Hemoglobin

    postoperative day 1

  • Postoperative Hematocrit

    postoperative day 1

  • Postoperative White Blood Cell Count

    postoperative day 1

  • +1 more other outcomes

Study Arms (2)

Enhanced Recovery After Surgery (ERAS)

EXPERIMENTAL

Participants received a structured Enhanced Recovery After Surgery (ERAS) perioperative care pathway for colorectal cancer surgery. The pathway included coordinated perioperative measures intended to reduce surgical stress and promote earlier postoperative recovery, including preoperative preparation and education, perioperative analgesic management, postoperative mobilization, nutritional recovery, and planned discontinuation of supportive devices and therapies.

Other: Enhanced Recovery After Surgery (ERAS) Pathway

Conventional Perioperative Care

ACTIVE COMPARATOR

Participants received the conventional perioperative care routinely provided for colorectal cancer surgery at the study center.

Other: Conventional Perioperative Care

Interventions

A multimodal perioperative care pathway applied before, during, and after colorectal cancer surgery, designed to reduce surgical stress and accelerate functional recovery.

Enhanced Recovery After Surgery (ERAS)

Routine perioperative care provided at the study center to patients undergoing colorectal cancer surgery.

Conventional Perioperative Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Diagnosis of colorectal cancer.
  • Scheduled to undergo surgical resection of the colorectal tumor.
  • Ability to understand and communicate in Greek.
  • Sufficient cognitive capacity to understand the study information, provide informed consent, and participate in the study procedures.

You may not qualify if:

  • Current treatment for chronic pain.
  • Use of psychopharmacological medication as defined in the study protocol.
  • Acute or chronic renal disease.
  • Acute or chronic hepatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Anticancer Oncology Hospital of Athens "Saint Savvas"

Athens, 11522, Greece

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative ComplicationsPain, Postoperative

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Officials

  • Martha Kelesi, Prof

    Nursing Department, University of West Attica

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not feasible because the ERAS pathway involved identifiable perioperative care practices implemented by the clinical team.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of two parallel groups: an Enhanced Recovery After Surgery (ERAS) perioperative care pathway or conventional perioperative care. Outcomes were assessed during the postoperative period through hospital discharge.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Manager, Anesthesiology Department, General Anticancer Oncology Hospital of Athens "Agios Savvas"; PhD, Postdoctoral Researcher, University of West Attica

Study Record Dates

First Submitted

October 18, 2026

First Posted

October 22, 2026

Study Start

September 17, 2024

Primary Completion

June 25, 2025

Study Completion

July 30, 2025

Last Updated

October 22, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared because no prospective data-sharing framework or participant consent for external data sharing was established for this study.

Locations