Cancer of ColonNCT03928678
Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
A study testing enhanced recovery after surgery program in colorectal cancer surgery in people with Cancer of Colon, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cancer of Colon
- What is being tested?
- enhanced recovery after surgery program in colorectal cancer surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≤ 60 years,
- Good nutrition,
- No systemic infection and
- Elective laparoscopic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
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.
- Conditions
- Cancer of Colon
- Being tested
- enhanced recovery after surgery program in colorectal cancer surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recovery after surgery program in colorectal cancer surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| thefast track (FTS group) | Active comparator | Not described Receives: Procedure: enhanced recovery after surgery program in colorectal cancer surgery |
| Thecontrolgroup | Placebo comparator | Not described Receives: Procedure: enhanced recovery after surgery program in colorectal cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay in days
length of hospital stay in days
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 May 2019
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Adel El sherif,MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928678
- Sponsor's protocol ID
- 458
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03928678
- Acronym / sponsor ID
- 458
- Conditions
- Cancer of Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≤ 60 years,
- Good nutrition,
- No systemic infection and
- Elective laparoscopic surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced recovery after surgery program in colorectal cancer surgeryto determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery. | Procedure or surgery | Thecontrolgroup, thefast track (FTS group) |
Primary outcome
length of hospital stay in days
Time frame: 4 days
length of hospital stay in days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced recovery after surgery program in colorectal cancer surgery in people with Cancer of Colon, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of hospital stay in days (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.