Colorectal SurgeryWeb-visitNCT05084131
Web-based Visit for Colorectal Surgery
An observational study of Colorectal Surgery, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The purpose of this study to evaluate how well an online format would work for the first post-operative visit after a patient undergoes colon and rectal surgery. This online format is integrated into Epic MyChart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Use of an online questionnaire as follow-up after abdominal colorectal surgery
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2019to 15 Apr 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent elective abdominal colorectal surgery
Who may be able to join
- Age 18 or older
- Planned/underwent surgery that was performed by a surgeon in the Division of Colon and Rectal Surgery
- Requires a post-operative follow-up outpatient visit 2-3 weeks from surgery or from discharge from hospital
- Has access to a smart mobile phone, tablet or computer to access online web interface for the web-based visit
- Patients with an Epic MyChart account set up.
- Has ability to take photographs of surgical incision or has access to someone who can take a picture for them.
Who cannot join
- Requires visiting nurse services at discharge from hospital
- Cannot use web-based interface or unable to complete questions online
- Cannot read English, speak English, or would require interpreter services. The reason for excluding these patients is there are not yet MyChart services available in non-English languages at Umass Memorial. It would not be fiscally possible to acquire these for a pilot feasibility study. As the MyChart experience is meant to be completed at home, it would not be possible to provider a medical interpreter in a non-office or hospital setting.
- Adults unable to consent (adults lacking capacity)
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
- Patients undergoing anal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: Feasibility of Online Visit Format for Post-Operative Visit After Colon and Rectal Surgery
The purpose of this study to evaluate how well an online format would work for the first post-operative visit after a patient undergoes colon and rectal surgery. This online format is integrated into Epic MyChart. This study aims to determine whether the online format is feasible and acceptable to patients and surgeons as a standard post-operative visit.
Read the detailed description
Participants were asked to complete a post-operative survey using an online patient portal, EPIC MyChart, after elective abdominal colon or rectal resection. Participants were also asked to do upload a picture of their incisions. Colorectal surgeons reviewed responses/pictures and communicated concerns/recommendations via the same patient portal. At the in-person follow-up visit, both patients and colorectal surgeons completed a satisfaction survey regarding the both visit types.
- Conditions
- Colorectal Surgery
- Being tested
- Use of an online questionnaire as follow-up after abdominal colorectal surgery
- Keywords
- online visit, web visit, patient portal, colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an online questionnaire as follow-up after abdominal colorectal surgeryOther
Patients were asked to complete a questionnaire via the institutional patient portal. Participants were also asked to upload a photo of their respective incisions. Participants then had an in-person follow-up visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with questionnaire
After the in-person follow-up visit, patients were asked to complete a satisfaction questionnaire of the online visit survey
Measured: 2 weeks
Provider satisfaction with questionnaire
After the in-person follow-up visit, colorectal surgeons were asked to complete a satisfaction survey
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start14 May 2019
- Primary completion15 Feb 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Maykel, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084131
- Sponsor's protocol ID
- H00017264
- Acronym
- Web-visit
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beauharnais CC, Hill SS, Sturrock PR, Davids JS, Alavi K, Maykel JA. Efficacy and satisfaction of asynchronous TeleHealth care compared to in-person visits following colorectal surgical resection. Surg Endosc. 2022 Dec;36(12):9106-9112. doi: 10.1007/s00464-022-09383-8. Epub 2022 Jun 17.
PubMed 35713720
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Online Visit Format for Post-Operative Visit After Colon and Rectal Surgery
- ClinicalTrials.gov ID
- NCT05084131
- Acronym / sponsor ID
- Web-visit / H00017264
- Conditions
- Colorectal Surgery
- Keywords
- online visit, web visit, patient portal, colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 19 Oct 2021 (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 purpose of this study to evaluate how well an online format would work for the first post-operative visit after a patient undergoes colon and rectal surgery. This online format is integrated into Epic MyChart. This study aims to determine whether the online format is feasible and acceptable to patients and surgeons as a standard post-operative visit.
Detailed description
Participants were asked to complete a post-operative survey using an online patient portal, EPIC MyChart, after elective abdominal colon or rectal resection. Participants were also asked to do upload a picture of their incisions. Colorectal surgeons reviewed responses/pictures and communicated concerns/recommendations via the same patient portal. At the in-person follow-up visit, both patients and colorectal surgeons completed a satisfaction survey regarding the both visit types.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective abdominal colorectal surgery
Key inclusion criteria (6 listed)
- Age 18 or older
- Planned/underwent surgery that was performed by a surgeon in the Division of Colon and Rectal Surgery
- Requires a post-operative follow-up outpatient visit 2-3 weeks from surgery or from discharge from hospital
- Has access to a smart mobile phone, tablet or computer to access online web interface for the web-based visit
- Patients with an Epic MyChart account set up.
Key exclusion criteria (8 listed)
- Requires visiting nurse services at discharge from hospital
- Cannot use web-based interface or unable to complete questions online
- Cannot read English, speak English, or would require interpreter services. The reason for excluding these patients is there are not yet MyChart services available in non-English languages at Umass Memorial. It would not be fiscally possible to acquire these for a pilot feasibility study. As the MyChart experience is meant to be completed at home, it would not be possible to provider a medical interpreter in a non-office or hospital setting.
- Adults unable to consent (adults lacking capacity)
- Individuals who are not yet adults (infants, children, teenagers)
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 |
|---|---|---|
| Use of an online questionnaire as follow-up after abdominal colorectal surgeryPatients were asked to complete a questionnaire via the institutional patient portal. Participants were also asked to upload a photo of their respective incisions. Participants then had an in-person follow-up visit. | Other | – |
Primary outcome
Patient satisfaction with questionnaire
Time frame: 2 weeks
After the in-person follow-up visit, patients were asked to complete a satisfaction questionnaire of the online visit survey
Provider satisfaction with questionnaire
Time frame: 2 weeks
After the in-person follow-up visit, colorectal surgeons were asked to complete a satisfaction survey
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 28 Oct 2021.
- Derived from this study: PubMed 35713720Beauharnais CC, Hill SS, Sturrock PR, Davids JS, Alavi K, Maykel JA. Efficacy and satisfaction of asynchronous TeleHealth care compared to in-person visits following colorectal surgical resection. Surg Endosc. 2022 Dec;36(12):9106-9112. doi: 10.1007/s00464-022-09383-8. Epub 2022 Jun 17.
- Individual participant dataSharing planned: No
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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?
An observational study of Colorectal Surgery, run by University of Massachusetts, Worcester at 1 site in United States.
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 6 inclusion and 8 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 28 Oct 2021. 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 United States. 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. 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?
Patient satisfaction with questionnaire (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084131, which also lists 1 linked publication.
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 28 Oct 2021.