Other Surgical ProceduresNCT01726231
Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
An observational study of Other Surgical Procedures, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Other Surgical Procedures
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2012to Dec 2013
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: the patiens undergoing laparoscopic surgery for various indications
Who may be able to join
- the patients who performed laparoscopic surgery
Who cannot join
- the patients who suspected pregnancy
- large scale intrabdominal mass
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul
About this study
In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.
Read the detailed description
40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.
- Conditions
- Other Surgical Procedures
- Keywords
- Laparoscopic access, Abdominal wall lifting, Direct trocar insertion, Safety endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Surgical ProceduresStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- TANER A USTA, M.D., Principal investigator, Bagcilar Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726231
- Sponsor's protocol ID
- BEH GynObs-2
- Status last verified
- Dec 2013
- First submitted
- 9 Nov 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
- ClinicalTrials.gov ID
- NCT01726231
- Acronym / sponsor ID
- BEH GynObs-2
- Conditions
- Other Surgical Procedures
- Keywords
- Laparoscopic access, Abdominal wall lifting, Direct trocar insertion, Safety endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Nov 2012 (estimated)
- 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.
In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.
Detailed description
40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the patiens undergoing laparoscopic surgery for various indications
Key inclusion criteria (1 listed)
- the patients who performed laparoscopic surgery
Key exclusion criteria (2 listed)
- the patients who suspected pregnancy
- large scale intrabdominal mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry.
Time frame: 2-3 months
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 25 Dec 2013.
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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.
TANER A USTA, M.D. principal investigator
Bagcilar Training and Research Hospital, Istanbul, Turkey
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 Other Surgical Procedures, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 25 Dec 2013. 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 Turkey (Türkiye). 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?
The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry. (time frame: 2-3 months). 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 25 Dec 2013.