Colorectal DisordersAirSealNCT01740011
Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
A study testing Laparoscopic surgery in people with Colorectal Disorders and Hernia, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial summary
The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Disorders, Hernia, Incidence for Cholecystectomy
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Mar 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients recruited for laparoscopic surgery i.e. cholecystectomy, colorectal surgery, hernia repair
- Written informed consent
- ≥ 18 years of age
Who cannot join
- Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction
- ≤18 years of age
- Pregnancy and lactation
- Previous extensive abdominal surgery
- Acute surgical intervention
Trial locations and contacts
1 site in 1 country.
Austria1 site
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Upper Austria, 4010
About this study
Official title: A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems.
It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.
- Conditions
- Colorectal Disorders, Hernia, Incidence for Cholecystectomy
- Being tested
- Laparoscopic surgery
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Laparoscopic surgery with AirSeal CO2 pressure insufflation Receives: Procedure: Laparoscopic surgery |
| Group S | Active comparator | Laparoscopic surgery with standard CO2 pressure insufflation Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of surgery
Time of surgery, expressed in minutes from the time of incising to suturing the skin.
Measured: one year
shoulder pain
Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).
Measured: one year
Secondary outcomes (2)
Immunological aspects
Examine changes in the concentration of certain cytokines and angiogenic factors serum levels in the early postoperative period after laparoscopic surgery procedures performed with AirSeal® versus standard- pressure CO2 pneumoperitoneum.
Measured: one year
postoperative complications
Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruzica-Rosalia Luketina, MD, Principal investigator, Krankenhaus Barmherzige Schwestern Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740011
- Sponsor's protocol ID
- AT-1112-RL
- Acronym
- AirSeal
- Status last verified
- Jan 2014
- First submitted
- 23 Nov 2012
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gallioli A, De Lorenzis E, Lievore E, Boeri L, Colombo L, Fontana M, Breda A, Montanari E, Albo G. The Effect of CO2 Pressure and Flow Variation on Carbon Particles Spread During Pneumoperitoneum: An Experimental Study. J Endourol. 2022 Jun;36(6):807-813. doi: 10.1089/end.2021.0336. Epub 2022 May 17.
PubMed 34779236Luketina R, Luketina TLH, Antoniou SA, Kohler G, Konneker S, Manzenreiter L, Wundsam H, Koch OO, Knauer M, Emmanuel K. Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal(R). Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.
PubMed 32767145Luketina RR, Knauer M, Kohler G, Koch OO, Strasser K, Egger M, Emmanuel K. Comparison of a standard CO(2) pressure pneumoperitoneum insufflator versus AirSeal: study protocol of a randomized controlled trial. Trials. 2014 Jun 20;15:239. doi: 10.1186/1745-6215-15-239.
PubMed 24950720
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
- ClinicalTrials.gov ID
- NCT01740011
- Acronym / sponsor ID
- AirSeal / AT-1112-RL
- Conditions
- Colorectal Disorders, Hernia, Incidence for Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Dec 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.
The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems.
It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Laparoscopic surgeryLaparoscopic surgery with AirSeal CO2 pressure insufflation |
| Group S | Active comparator | Procedure: Laparoscopic surgeryLaparoscopic surgery with standard CO2 pressure insufflation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients recruited for laparoscopic surgery i.e. cholecystectomy, colorectal surgery, hernia repair
- Written informed consent
- ≥ 18 years of age
Key exclusion criteria (5 listed)
- Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction
- ≤18 years of age
- Pregnancy and lactation
- Previous extensive abdominal surgery
- Acute surgical intervention
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 surgery | Procedure or surgery | Group A, Group S |
Primary outcome
time of surgery
Time frame: one year
Time of surgery, expressed in minutes from the time of incising to suturing the skin.
shoulder pain
Time frame: one year
Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).
2 secondary outcomes
Immunological aspects
Time frame: one year
postoperative complications
Time frame: one year
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 8 Sep 2014.
- Derived from this study: PubMed 34779236Gallioli A, De Lorenzis E, Lievore E, Boeri L, Colombo L, Fontana M, Breda A, Montanari E, Albo G. The Effect of CO2 Pressure and Flow Variation on Carbon Particles Spread During Pneumoperitoneum: An Experimental Study. J Endourol. 2022 Jun;36(6):807-813. doi: 10.1089/end.2021.0336. Epub 2022 May 17.
- Derived from this study: PubMed 32767145Luketina R, Luketina TLH, Antoniou SA, Kohler G, Konneker S, Manzenreiter L, Wundsam H, Koch OO, Knauer M, Emmanuel K. Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal(R). Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.
- Derived from this study: PubMed 24950720Luketina RR, Knauer M, Kohler G, Koch OO, Strasser K, Egger M, Emmanuel K. Comparison of a standard CO(2) pressure pneumoperitoneum insufflator versus AirSeal: study protocol of a randomized controlled trial. Trials. 2014 Jun 20;15:239. doi: 10.1186/1745-6215-15-239.
- Investigator related informationsLink provided by the sponsor.
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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.
Ruzica-Rosalia Luketina, MD principal investigator
Krankenhaus Barmherzige Schwestern Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery in people with Colorectal Disorders and Hernia, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
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 5 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 8 Sep 2014. 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 Austria. 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?
time of surgery (time frame: one year). 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?
On the ClinicalTrials.gov record for NCT01740011, which also lists 3 linked publications.
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 8 Sep 2014.