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Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03159637
Enrollment
60
Registered
2017-05-19
Start date
2017-05-30
Completion date
2018-12-01
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopy

Keywords

Pneumoperitoneum, Trendelenburg position, intra-abdominal pressure

Brief 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.

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.

Interventions

PROCEDURELaparoscopic 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years

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

Design outcomes

Primary

MeasureTime frameDescription
mean arterial blood pressurewithin the duration of the operationmean arterial blood pressure will be monitored at different times
Pulmonary function testswithin the first 24 hoursforced expiratory volume at one second

Secondary

MeasureTime frameDescription
Intra-abdominal pressurewithin the first 24 hoursIntra-abdominal pressure by direct measurement and indirect by Foley´s catheter will be monitored at different times (Cm water)
PaO2within the first 24 hoursPaO2 will be monitored at different times
Analgesic requirementwithin the first 24 hoursAnalgesic requirement will be monitored at different times by special scale (VAS)
Postoperative nausea and vomitingwithin the first 24 hoursPostoperative nausea and vomiting will be monitored at different times by special scale
Arterial to end-tidal PaCO2- differencewithin the first 24 hoursArterial to end-tidal PaCO2- difference will be monitored at different times

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026