Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159637
• Other study ID #: IRB000087698
• Status: Completed
• Start date: May 30, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2018
• Est. primary completion date: November 12, 2018
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy
• Pneumoperitoneum

Intervention

Procedure:
• Laparoscopic Surgery
Insufflation of a gas (carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum will be done. The positioning of the patients in Trendelenburg position will be done. intraoperative and postoperative outcomes will be assesed

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean arterial blood pressure	mean arterial blood pressure will be monitored at different times	within the duration of the operation
Primary	Pulmonary function tests	forced expiratory volume at one second	within the first 24 hours
Secondary	PaO2	PaO2 will be monitored at different times	within the first 24 hours
Secondary	Arterial to end-tidal PaCO2- difference	Arterial to end-tidal PaCO2- difference will be monitored at different times	within the first 24 hours
Secondary	Intra-abdominal pressure	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
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting will be monitored at different times by special scale	within the first 24 hours
Secondary	Analgesic requirement	Analgesic requirement will be monitored at different times by special scale (VAS)	within the first 24 hours