Adnexal Benign PathologyNCT02625025
Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology
A study testing Low pression pneumoperitoneum, Standard Pression Pneumoperitoneum and Single Port Access Laparoscopy in people with Adnexal Benign Pathology, run by University of Cagliari.
Trial summary
During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adnexal Benign Pathology
- What is being tested?
- Low pression pneumoperitoneum, Standard Pression Pneumoperitoneum and Single Port Access Laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2018
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients 18- 45 years old
- elective laparoscopic operation
- informed consent
Who cannot join
- BMI > 30 kg/cm2
- pregnancy
- converting to laparotomy
- malignant disease
- unable or unwilling to give written consent
About this study
During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic rescue dosage in patients undergoing minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal pathologies.
- Conditions
- Adnexal Benign Pathology
- Being tested
- Low pression pneumoperitoneum, Standard Pression Pneumoperitoneum, Single Port Access Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pression pneumoperitoneumProcedure or surgery
Pneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity.
Intra-abdominal pressure will be maintained at 8 mm Hg during pneumoperitoneum creation and insertion of trocars.
Standard Pression PneumoperitoneumProcedure or surgery
Pneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity.
Intra-abdominal pressure will be maintained at 12 mm Hg during pneumoperitoneum creation and insertion of trocars.
Single Port Access LaparoscopyProcedure or surgery
Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology
| Study group | Role | What they receive |
|---|---|---|
| Low pression pneumoperitoneum | Experimental | Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg) Receives: Procedure: Low pression pneumoperitoneum; Procedure: Single Port Access Laparoscopy |
| Standard pression pneumoperitoneum | Experimental | Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg) Receives: Procedure: Standard Pression Pneumoperitoneum; Procedure: Single Port Access Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured on a VAS scale
Experienced pain over the last six hours measured on a VAS scale
Measured: 6 hours
Secondary outcomes (5)
Operation time
Operating time in minutes.
Measured: 0 hours after the operation
Blood loss in ml
Estimated blood loss in ml.
Measured: 0 hours after the operation
Complications
Complications during surgery and late complications.
Measured: Two months
Shoulder tip pain measured on a VAS scale
Experienced shoulder tip pain over the last 24 hours measured on a VAS scale.
Measured: 24 hours
Postoperative pain measured on a VAS scale
Experienced pain over the last 24 hours measured on a VAS scale.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal Benign PathologyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625025
- Sponsor's protocol ID
- SPALPression
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology
- ClinicalTrials.gov ID
- NCT02625025
- Acronym / sponsor ID
- SPALPression
- Conditions
- Adnexal Benign Pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Dec 2015 (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.
During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic rescue dosage in patients undergoing minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal pathologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pression pneumoperitoneum | Experimental | Procedure: Low pression pneumoperitoneum, Procedure: Single Port Access LaparoscopyPatients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg) |
| Standard pression pneumoperitoneum | Experimental | Procedure: Standard Pression Pneumoperitoneum, Procedure: Single Port Access LaparoscopyPatients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients 18- 45 years old
- elective laparoscopic operation
- informed consent
Key exclusion criteria (5 listed)
- BMI > 30 kg/cm2
- pregnancy
- converting to laparotomy
- malignant disease
- unable or unwilling to give written consent
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 |
|---|---|---|
| Low pression pneumoperitoneumPneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity. Intra-abdominal pressure will be maintained at 8 mm Hg during pneumoperitoneum creation and insertion of trocars. | Procedure or surgery | Low pression pneumoperitoneum |
| Standard Pression PneumoperitoneumPneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity. Intra-abdominal pressure will be maintained at 12 mm Hg during pneumoperitoneum creation and insertion of trocars. | Procedure or surgery | Standard pression pneumoperitoneum |
| Single Port Access LaparoscopyLaparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology | Procedure or surgery | Low pression pneumoperitoneum, Standard pression pneumoperitoneum |
Primary outcome
Postoperative pain measured on a VAS scale
Time frame: 6 hours
Experienced pain over the last six hours measured on a VAS scale
5 secondary outcomes
Operation time
Time frame: 0 hours after the operation
Blood loss in ml
Time frame: 0 hours after the operation
Complications
Time frame: Two months
Shoulder tip pain measured on a VAS scale
Time frame: 24 hours
Postoperative pain measured on a VAS scale
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low pression pneumoperitoneum, Standard Pression Pneumoperitoneum and Single Port Access Laparoscopy in people with Adnexal Benign Pathology, run by University of Cagliari.
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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Postoperative pain measured on a VAS scale (time frame: 6 hours). 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 9 Dec 2015.