LaparoscopyNCT03159637
Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study
An observational study of Laparoscopy, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Laparoscopy
- What is being tested?
- Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: female patients only
Who may be able to join
- Age range 18-50
- ASA 1
- Elective gynecological laparoscopic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Laparoscopy
- Being tested
- Laparoscopic Surgery
- Keywords
- Pneumoperitoneum, Trendelenburg position, intra-abdominal pressure
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic SurgeryProcedure or 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
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure
mean arterial blood pressure will be monitored at different times
Measured: within the duration of the operation
Pulmonary function tests
forced expiratory volume at one second
Measured: within the first 24 hours
Secondary outcomes (5)
PaO2
PaO2 will be monitored at different times
Measured: within the first 24 hours
Arterial to end-tidal PaCO2- difference
Arterial to end-tidal PaCO2- difference will be monitored at different times
Measured: within the first 24 hours
Intra-abdominal pressure
Intra-abdominal pressure by direct measurement and indirect by Foley´s catheter will be monitored at different times (Cm water)
Measured: within the first 24 hours
Postoperative nausea and vomiting
Postoperative nausea and vomiting will be monitored at different times by special scale
Measured: within the first 24 hours
Analgesic requirement
Analgesic requirement will be monitored at different times by special scale (VAS)
Measured: within the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start30 May 2017
- Primary completion12 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed K Abd-Elshafy, M.D, Principal investigator, Associate Profossor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159637
- Sponsor's protocol ID
- IRB000087698
- Status last verified
- Dec 2018
- First submitted
- 17 May 2017
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Posture and Prolonged Pneumoperitoneum on Intra-Operative and Postoperative Outcomes During Gynecological Laparoscopic Surgery: An Observational Clinical Study
- ClinicalTrials.gov ID
- NCT03159637
- Acronym / sponsor ID
- IRB000087698
- Conditions
- Laparoscopy
- Keywords
- Pneumoperitoneum, Trendelenburg position, intra-abdominal pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- female patients only
Key inclusion criteria (3 listed)
- Age range 18-50
- ASA 1
- Elective gynecological laparoscopic surgery
Key exclusion criteria (6 listed)
- Severe ischemic or valvular heart disease
- Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury)
- Hepatic or renal impairment
- Emergency surgery
- Open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic SurgeryInsufflation 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 | Procedure or surgery | – |
Primary outcome
mean arterial blood pressure
Time frame: within the duration of the operation
mean arterial blood pressure will be monitored at different times
Pulmonary function tests
Time frame: within the first 24 hours
forced expiratory volume at one second
5 secondary outcomes
PaO2
Time frame: within the first 24 hours
Arterial to end-tidal PaCO2- difference
Time frame: within the first 24 hours
Intra-abdominal pressure
Time frame: within the first 24 hours
Postoperative nausea and vomiting
Time frame: within the first 24 hours
Analgesic requirement
Time frame: within the first 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayed K Abd-Elshafy, M.D principal investigator
Associate Profossor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean arterial blood pressure (time frame: within the duration of the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.