Condition category
Surgery
Date applied
21/03/2017
Date assigned
29/03/2017
Last edited
29/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Elena Arabadzhieva

ORCID ID

Contact details

Medical University of Sofia
1 Georgi Sofiiski Street
Sofia
1431
Bulgaria

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 measures

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

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

Sponsor information

Organisation

University Hospital "Alexandrovska"

Sponsor details

1 Georgi Sofiiski Street
Sofia
1431
Bulgaria

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes