Waist circumference as an estimator of abdominal wall depth
| ISRCTN | ISRCTN33200631 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33200631 |
| IRAS number | 321171 |
| Secondary identifying numbers | IRAS 321171, CPMS 55619 |
- Submission date
- 08/01/2023
- Registration date
- 02/02/2023
- Last edited
- 03/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
This study seeks to assess whether waist circumference can estimate the abdominal wall depth to a reliable degree of accuracy so as to be incorporated in a nomogram that would categorise suggested Veress needle abdominal insertion depth according to waist circumference range. This would be helpful in guiding initial Veress entry into the abdominal cavity during laparoscopic (keyhole) or robotic surgery where entry is achieved blindly without standardised depth advice. The research question is therefore ‘Can waist circumference estimate abdominal wall depth?’ Due to the urgent need for safety mechanisms to be incorporated in the conduct of laparoscopic abdominal wall injury, this study attempts to provide some guidance into how deep the Veress needle should be inserted when a Veress needle is being used as the first entry abdominal device and insufflator. The study aims to improve safety in laparoscopic entry where a Veress needle is used by providing insertion depth guidance. It is aimed to reduce the number of failed entries or complicated entries. The traditional Body Mass Index (BMI) will also be taken to see if it makes a better correlation than abdominal girth.
Who can participate
Any adult patient undergoing non-urgent scheduled CT or MRI abdominal imaging
What does the study involve?
The abdominal wall depth will be measured directly from CT or MRI scans of the waist, whilst patient abdominal circumference, weight and height measurements will be physically obtained.
What are the possible benefits and risks of participating?
The possible benefits of participating are that the research team will assess the validity of the relationship between waist circumference and abdominal wall depth for the first time so this can be taken into account whenever patients are subjected to minimally invasive surgery where entry is likely to be initially accomplished through the use of the Veress needle. There is minimal risk to participation, if any, there may be an inconvenience in taking the physical measurements. Weight and height are routinely taken, however, additionally taking the waist circumference is not envisaged to create significant delay.
Where is the study run from?
University Hospitals Bristol and Weston NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2022 to July 2024
Who is funding the study?
This study is part of a PhD project funded by UK Research and Innovation (UKRI) ESPRC Centres for Doctoral Training Digital Health & Care (UK)
Who is the main contact?
Chimwemwe Miti (Principal researcher and PhD student), c.miti@bristol.ac.uk (UK)
Contact information
Principal Investigator
EPSRC Centre for Doctoral Training (CDT) in Digital Health & Care
School of Computer Science
Electrical and Electronic Engineering and Engineering Maths
1 Cathedral Square
Trinity Street
Bristol
BS1 5DD
United Kingdom
 ORCID ID |
0000-0001-8309-269X |
|---|---|
| Phone | +44 (0)1782730733 |
| zb20006@bristol.ac.uk |
Scientific
Ada Lovelace Building
Department of Engineering Mathematics
University Walk
Bristol
BS8 1TW
United Kingdom
| ORCID ID |
0000-0001-8053-9249 |
|---|---|
| Phone | +44 (0)117 4282489 |
| hermes.gadelha@bristol.ac.uk |
Public
St Michael’s Hospital
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol
BS2 8EG
United Kingdom
| Phone | None provided |
|---|---|
| lynne.armstrong@uhbw.nhs.uk |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 43007 PIS v1.6 02July2021.pdf |
| Scientific title | Investigating whether the abdominal waist circumference or abdominal girth can be employed as an accurate estimate of abdominal wall depth as measured from the base of the umbilicus |
| Study hypothesis | Measured waist circumference is a better estimator than Body Mass Index (BMI) of the abdominal wall depth |
| Ethics approval(s) | Approved 21/07/2023, London - Harrow Research Ethics Committee (Health Research Authority Bristol HRA Centre, Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 (0)2071048289; harrow.rec@hra.nhs.uk), ref: 23/PR/0600 |
| Condition | Assessing the correlation between waist circumference and abdominal wall depth |
| Intervention | For eligible participants undergoing cross-sectional imaging (CT or MRI scans) as part of their routine diagnostic workup, their waist circumference (additional to height and weight which are already routinely collected before any CT or MRI scan) will be measured. The principal investigator who is a PhD student and a medical doctor trained in taking patient physical parameters will measure the waist circumference, height and weight. The measurements of physical parameters are undertaken face-to-face in the imaging department where the patient will be attending their scheduled scan. These data will be analysed mathematically against the abdominal wall depth taken from the base of the umbilicus to the peritoneum and which will be measured directly from an appropriate slice of the cross-sectional image series. |
| Intervention type | Other |
| Primary outcome measure | 1. Abdominal wall depth from the centre of the umbilicus to the peritoneal edge in millimetres (mm) measured using cross-sectional imaging (CT or MRI scans) at one timepoint 2. Waist circumference measured in a complete circle passing through the centre of the umbilicus in millimetres (mm) using a measuring tape at one timepoint 3. Height and weight measured using routine procedures in centimetres (cm) and kilograms (kg), respectively, at one timepoint |
| Secondary outcome measures | Performance of the relationship between waist circumference measurements and abdominal wall depth and measured BMI to estimate abdominal wall depth at a single time point |
| Overall study start date | 01/04/2022 |
| Overall study end date | 21/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 385 |
| Total final enrolment | 386 |
| Participant inclusion criteria | 1. Adult patients aged 18 years old and over 2. Undergoing routine scheduled cross-sectional imaging that includes their abdomen 3. Mobile patients 4. Able to consent and volunteer their participation in the study |
| Participant exclusion criteria | 1. Patients with uncorrected abdominal wall hernias or abdominal wall defects 2. Patients undergoing emergency CT scans requested from the emergency department |
| Recruitment start date | 31/07/2023 |
| Recruitment end date | 24/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
C/o: Secretary to Dr Lynne Armstrong
Consultant Radiologist
Department of Radiology, Diagnostic & Therapy Division
Bristol Royal Infirmary
Marlborough Street
Bristol
BS1 3NU
England
United Kingdom
| Phone | +44 (0)117 342 9383 |
|---|---|
| ruth.smith2@uhbw.nhs.uk |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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 will be stored in a publicly available repository. The Research Data Storage Facility, Digital Health Doc (digitaldoc.info) will be the most robust long-term storage facility for my project data so that the data is accessible by designated researchers should I not be present and when the project ends and I leave the University. The type of data stored will be metric measurements of abdominal wall depth, height, weight, waist circumference, and Body Mass Index. Consent from participants was required and obtained. Data anonymization was as per protocol. There are no ethical or legal restrictions foreseen because only measurements being taken will be stored, the scan images will not be stored. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.6 | 02/07/2021 | 16/01/2023 | No | Yes |
| Protocol file | version 1.0 | 31/12/2022 | 16/01/2023 | No | No |
Additional files
Editorial Notes
03/12/2024: The intention to publish date was changed from 21/11/2024 to 31/01/2025.
30/08/2024: The intention to publish date was changed from 21/08/2024 to 21/11/2024.
10/07/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2023 to 24/06/2024.
2. The overall study end date was changed from 01/11/2023 to 21/07/2024.
3. The intention to publish date was changed from 01/08/2024 to 21/08/2024.
4. Total final enrolment added.
08/07/2024: Ethics approval details added.
15/06/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2023 to 31/07/2023.
2. The recruitment end date was changed from 02/08/2023 to 31/08/2023.
17/03/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2023 to 01/06/2023.
2. The recruitment end date was changed from 02/05/2023 to 02/08/2023.
3. The overall trial end date was changed from 01/08/2023 to 01/11/2023.
01/03/2023: Internal review.
30/01/2023: Trial's existence confirmed by University Hospitals Bristol and Weston NHS Foundation Trust (UK).
