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Fecal ostomy surgery participants receiving the CI-oSurg for Surgery (CI-oSurg Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 weeks after intervention

Awards & highlights

CI-oSurg Trial Summary

This trial will test a new communication program for people undergoing fecal ostomy surgery. They will include 24 patients and 4 clinicians to see if the program is helpful. They will focus on patients

Who is the study for?

This trial is for adults over 18 who speak and read English fluently, and are about to have elective fecal ostomy surgery. It focuses on understanding the needs of these patients, especially those aged 65 or older.Check my eligibility

What is being tested?

The study tests a communication intervention designed for patients undergoing fecal ostomy surgery. The goal is to see if this approach helps with their recovery process. Participants will answer questionnaires at the start and four weeks after trying the intervention.See study design

What are the potential side effects?

Since this trial involves a communication strategy rather than medication, traditional side effects like you'd expect from drugs aren't applicable here.

CI-oSurg Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 weeks after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 weeks after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention Acceptability

Secondary outcome measures

Intervention Usability

Other outcome measures

Client Satisfaction Questionnaire

Emotional Distress

Hospital Anxiety and Depression Scale

+2 more

CI-oSurg Trial Design

1Treatment groups

Experimental Treatment

Group I: Fecal ostomy surgery participants receiving the CI-oSurgExperimental Treatment1 Intervention

This arm will include patients who are undergoing or have undergone fecal ostomy surgery and surgical clinicians caring for the patients who will receive the CI-oSurg intervention.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,613 Total Patients Enrolled

6 Trials studying Surgery

186,916 Patients Enrolled for Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participant enrollment for this research investigation?

"Indeed, the details on clinicaltrials.gov affirm that recruitment is ongoing for this trial. The study was initially listed on March 18, 2024, and last modified on March 27, 2024. They aim to recruit a total of 28 participants from a single site."

Answered by AI

Are there still opportunities for patients to participate in this ongoing research study?

"Indeed, records from clinicaltrials.gov highlight that this investigation is presently seeking participants. The trial was initially disclosed on March 18th, 2024, and its most recent update was on March 27th, 2024. They aim to enroll a total of 28 patients across one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Communication Intervention for Fecal Ostomy Surgery

Christy E. Cauley, MD, MPH 2024. "Communication Intervention for Fecal Ostomy Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06320002.

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