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

NCT ID: NCT04515485

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laparoscopy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing laparoscopy

The participants are patients that have undergone the laparoscopic surgery.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Obstetrics & Gynaecology

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Carrie S. Y. Wan

Role: CONTACT

Other Identifiers

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2019/01152

Identifier Type: -

Identifier Source: org_study_id

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