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NCT04515485 Clinical Trial

A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume

Laparoscopy Clinical Trial

Official title:
A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04515485
Other study ID # 2019/01152
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2020
Est. completion date June 2022

Study information
Verified date August 2020
Source National University Hospital, Singapore
Contact Carrie S. Y. Wan
Phone 67795555
Email obgwsyc@nus.edu.sg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective study to collect a nomogram of intra-abdominal volume correlated with height and weight for O&G patients undergoing minimally invasive surgery.

Description:

This is a prospective study from the date of approval of the study for a period of 24 months.

The potential participants are from O&G department who will be undergoing laparoscopy

The participant's height, weight, and total volume of carbon dioxide gas infused into the abdomen are collected from CPSS to create a standard operative pneumoperitoneum of 18mmHg for all patients undergoing laparoscopic procedures.

Patients with an abdomino-pelvic mass, or pelvic masses larger than 12 weeks size, or assessed to have an abdominal mass are excluded. Pregnant and/or breast feeding women are also excluded.

Specific patient identifiers will not be collected into the data collection and are not necessary to the study or to achieving to the objective of the study. Therefore data will not contain any identifiers.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date June 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 99 Years
Eligibility Inclusion Criteria:

- O&G patients that are undergoing laparoscopic surgery.

Exclusion Criteria:

- Patients with an abdomino-pelvic mass

- Patients with pelvic masses larger than 12 weeks size

- Patients assessed to have an abdominal mass

- Pregnant and/or breast feeding women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National University Hospital, Singapore

Outcome
Type Measure Description Time frame Safety issue
Primary Creation of a nomogram The study aims to generate a nomogram. 2 years
Primary Recording height in cm 2 years
Primary Recording weight In kg 2 years
Primary Recording intra-abdominal volume during surgery In ml 2 years
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