NCT03928678

Brief Summary

The aim of our study is to determine the effect of implementation of the ERAS (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 22, 2022

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

April 24, 2019

Last Update Submit

March 19, 2022

Conditions

Cancer of Colon

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay in days

    length of hospital stay in days

    4 days

Study Arms (2)

thefast track (FTS group)

ACTIVE COMPARATOR
Procedure: enhanced recovery after surgery program in colorectal cancer surgery

Thecontrolgroup

PLACEBO COMPARATOR
Procedure: enhanced recovery after surgery program in colorectal cancer surgery

Interventions

enhanced recovery after surgery program in colorectal cancer surgeryPROCEDURE

to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.

Thecontrolgroupthefast track (FTS group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≤ 60 years,
  • Good nutrition,
  • No systemic infection and
  • Elective laparoscopic surgery

You may not qualify if:

  • Age \>75 years,
  • Malnutrition or an organ system infection
  • Associated with obstruction, bleeding, emergency surgery or other surgical intervention
  • Tumor with extensive metastasis
  • Prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support
  • Previous history of abdominal surgery
  • Patient have previously undergone gastrostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Instuite

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

May 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

March 22, 2022

Record last verified: 2020-04

Locations

EG(1)