Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

December 4, 2018 updated by: Sayed Kaoud Abd-Elshafy, Assiut University

Impact Of Posture and Prolonged Pneumoperitoneum on Intra-Operative and Postoperative Outcomes During Gynecological Laparoscopic Surgery: An Observational Clinical Study

Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position and effects of carbon dioxide absorption cause changes in physiology, especially within the cardiovascular and respiratory systems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out after approval of the ethical committee of Faculty of Medicine, Assiut University. A full preoperative anesthetic assessment will be carried out. Particular attention to the cardiovascular and respiratory systems is essential because of potential effects of the pneumoperitoneum and patient position.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

female patients only

Description

Inclusion Criteria:

  1. Age range 18-50
  2. ASA 1
  3. Elective gynecological laparoscopic surgery

Exclusion Criteria:

  1. Severe ischemic or valvular heart disease
  2. Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury)
  3. Hepatic or renal impairment
  4. Emergency surgery
  5. Open surgery
  6. Previous abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean arterial blood pressure
Time Frame: within the duration of the operation
mean arterial blood pressure will be monitored at different times
within the duration of the operation
Pulmonary function tests
Time Frame: within the first 24 hours
forced expiratory volume at one second
within the first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2
Time Frame: within the first 24 hours
PaO2 will be monitored at different times
within the first 24 hours
Arterial to end-tidal PaCO2- difference
Time Frame: within the first 24 hours
Arterial to end-tidal PaCO2- difference will be monitored at different times
within the first 24 hours
Intra-abdominal pressure
Time Frame: within the first 24 hours
Intra-abdominal pressure by direct measurement and indirect by Foley´s catheter will be monitored at different times (Cm water)
within the first 24 hours
Postoperative nausea and vomiting
Time Frame: within the first 24 hours
Postoperative nausea and vomiting will be monitored at different times by special scale
within the first 24 hours
Analgesic requirement
Time Frame: within the first 24 hours
Analgesic requirement will be monitored at different times by special scale (VAS)
within the first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sayed K Abd-Elshafy, M.D, Associate Profossor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 30, 2017

Primary Completion (ACTUAL)

November 12, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (ACTUAL)

May 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB000087698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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