Plain English Summary
Background and study aims
A right hemiocolectomy is a surgical procedure that removes the right side of the colon (bowels). Sometimes this has to be done in an emergency setting without the benefit of preparing the bowels for surgery (by removing waste from the bowels). There are a wide range of diseases and complications that affect parts of the colon such as inflammatory (swelling) or malignant (cancerous) diseases, perforation (ruptures of the bowels), obstructions (blockages), impaired circulation (blood flow) and trauma. Sometimes a surgeon is unable to diagnose the issue causing them to be unable to determine if the issue is malignant or not. In cases that the issue is caused by benign (non cancerous) diseases the surgeons have to decide between an ileocolic resection (which removes only the last part of the small intestine and the first part of the colon) and a right hemicolectomy, however there is no clear criteria for surgeons on how to make this choice. This causes performing right colectomies to be the preferred type of treatment. The aim of this study is to investigative if right hemicolectomies performed in an emergency setting impairs the quality of life of patients.
Who can participate?
Adults aged 21 to 84 who require an emergency right hemiocolectomy.
What does the study involve?
Participants who have undergone an emergency right hemiocolectomy are invited to participate in this study. Participants fill out a quality of life survey one month after their surgery during a follow up appointment. Participants are then followed up four months after surgery and complete a telephone interview. The questionnaire asks participants to think about their irritable bowel symptoms on their quality of life over the last two months. This is done to see if right hemicolectomies decrease the quality of life or participants.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
University Hospital “Alexandrovska” (Bulgaria)
When is the study starting and how long is it expected to run for?
December 2011 to March 2017
Who is funding the study?
Investigator initiated and funded (Bulgaria)
Who is the main contact?
Dr Elena Arabadzhieva
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
emrighthemicol_QOL
Study information
Scientific title
Emergency right hemicolectomy: Indications and functional outcomes
Acronym
Study hypothesis
The aim of this study is to evaluate if right hemicolectomy performed in emergency setting impairs the quality of life of patients.
Ethics approval
The Ethical Committee of University Hospital “Alexandrovska”, 23/01/2012, ref: N 3/23.01.2012
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Emergency right hemicolectomies
Intervention
Participants who have had an emergency right hemicolectomy are invited to participate in this study. Participants answer a quality of life questionnaire (measured with the validated IBS-36 questionnaire) during an examination at the end of the first month after the surgical procedure and through a telephone interview four months after the study. The questionnaire asks participants to think about their irritable bowel syndrome (IBS) symptoms on their quality of life over a two month time frame. The data collected from the questionnaires is then analysed by the research team. This is done to see if right hemicolectomies decrease the quality of life of participants.
Participants are followed up four months after their initial assessment by telephone and are resurveyed using the validated IBS-36 questionnaire.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Quality of life is measured using the validated questionnaire IBS-36 at baseline (one month after surgery) and month four.
Secondary outcome measures
Safety is measured using validated questionnaire IBS-36 at baseline (one month after surgery) and month four.
Overall trial start date
05/12/2011
Overall trial end date
03/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients requiring emergency right hemicolectomy
2. Aged 21 and 84
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Malignant diseases
2. Patients who decline to participate
Recruitment start date
01/02/2012
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Bulgaria
Trial participating centre
University Hospital "Alexandrovska"
1 Georgi Sofiiski Street
Sofia
1431
Bulgaria
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Elena Arabadzhieva, elena_arabadjieva@mail.bg or elena_arabadjieva@abv.bg
Intention to publish date
03/03/2018
Participant level data
Available on request
Basic results (scientific)
Publication list