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NCT Number: NCT03159637

Pneumoperitoneum and 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.

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Key information

Conditions

Laparoscopy Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range 18-50
  • ASA 1
  • Elective gynecological laparoscopic surgery

Exclusion criteria

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

Treatment and study plan

Laparoscopic surgery

Procedure

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

Primary outcomes

  1. mean arterial blood pressure

    Time frame: within the duration of the operation

    mean arterial blood pressure will be monitored at different times

  2. Pulmonary function tests

    Time frame: within the first 24 hours

    forced expiratory volume at one second

Secondary outcomes

  1. PaO2

    Time frame: within the first 24 hours

    PaO2 will be monitored at different times

  2. 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

  3. 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)

  4. Postoperative nausea and vomiting

    Time frame: within the first 24 hours

    Postoperative nausea and vomiting will be monitored at different times by special scale

  5. Analgesic requirement

    Time frame: within the first 24 hours

    Analgesic requirement will be monitored at different times by special scale (VAS)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 19, 2017
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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