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Malignant Neoplasms of Female Genital OrgansPhase 2NCT03128281

Pneumoperitoneum Management With Low vs. Higher Pressure

A Phase 2 study testing Questionnaires, Conventional Insufflation System (CIS) and ConMed AirSeal Insufflation System (AIS) at Low Pressure in people with Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this clinical research study is to compare the level of pain 2 hours after surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low pressure setting or the standard insufflator (the conventional insufflation system, or CIS). Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Questionnaires, Conventional Insufflation System (CIS) and ConMed AirSeal Insufflation System (AIS) at Low Pressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2018to Jul 2022
Phase
Phase 2
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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
  • 18-80 years of age
  • Capable and willing to provide Informed consent
  • Acceptable candidate for laparoscopic/robotic GYN surgery as per discretion of the surgeon
  • If patient agrees to participate in the optional patient reported outcomes portion of the study, patient must be English speaking and willing to complete the MD Anderson Symptom Inventory (MDASI) questionnaires

Who cannot join

  • Active cutaneous infection or inflammation
  • Pre-existing active or untreated immunodeficiency disorder and/or chronic use of systemic steroids
  • Uncontrolled diabetes mellitus
  • Severe co-existing morbidities having a life expectancy of less than 30 days
  • Significant anemia with hemoglobin level less than 7 g/dL or a hematocrit less than 21%
  • Females who are pregnant or lactating
Show all 11Show fewer
  • Patients presenting with ascites
  • Patients with Chronic Pain Syndrome or requiring/using chronic pain medications
  • Patients undergoing diagnostic laparoscopy
  • Patients planning to undergo hand-assisted laparoscopy
  • Severe comorbidities (atrial fibrillation, pulmonary hypertension, etc...)

About this study

Official title: A Single Center, Prospective, Randomized, Controlled Study to Evaluate Shoulder Pain, Cardiovascular Changes, Pulmonary Pressures and Perioperative Outcomes Related to the Use of the AirSeal® Insufflation System (AIS) at Low and Higher Pressure Pneumoperitoneum vs. Conventional Insufflation

The goal of this clinical research study is to compare the level of pain 2 hours after surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low pressure setting or the standard insufflator (the conventional insufflation system, or CIS). "Insufflation" is the creation of a pressure barrier of air/gas within the abdomen that allows the surgeon more space to work in.

Read the detailed description

Baseline Visit:

If participant agrees to take part in this study, within 30 days before surgery, participant will be asked to complete a questionnaire about participant's pain level and any drugs participant may be taking for it. It should take about 5 minutes to complete.

Study Groups:

Participant will be randomly assigned to 1 of 3 groups (as in a roll of dice). This is done because no one knows if one study group is better, the same, or worse than the other group. Participant has an equal chance of being placed in each group. Participant will not know which group participant is assigned to.

  • If participant is in Group 1, participant will have the CIS used during surgery.
  • If participant is in Group 2, participant will have the AIS used at a lower pressure during surgery.
  • If participant is in Group 3, participant will have the AIS used at a higher pressure during surgery.

Surgery:

Participant will then have surgery. Participant will sign a separate consent for the surgery that explains the procedure, the risks of the surgery, and the risks of CIS.

Blood (about 3 teaspoons each time) will be collected 1 time before surgery, 2 times during surgery, and 1 time after surgery is completed. Routine tests and tests to learn how participant's body reacts to inflammation will be performed on this blood.

Questionnaires:

After surgery, participant will complete the questionnaire about participant's pain level and any drugs participant is taking. Participant will complete this questionnaire:

  • Two (2) hours after surgery,
  • When participant leaves the post-anesthesia care unit (PACU), and
  • When participant is discharged from the hospital

If participant is discharged the same day as participant's surgery, participant will be called by the study staff to answer the questionnaire the following day.

Length of Study Participation:

Participation in the study will be over after participant completes the questionnaire after participant is discharged, unless participant agrees to complete additional optional questionnaires.

This is an investigational study. Both AirSeal® insufflation system (AIS) and conventional insufflation systems (CIS) are FDA approved and commercially available. It is investigational to compare the effects of high and low pressures using the AIS.

Up to 240 participants will be enrolled in this study. All will take part at MD Anderson.

Being tested
Questionnaires, Conventional Insufflation System (CIS), ConMed AirSeal Insufflation System (AIS) at Low Pressure, ConMed AirSeal Insufflation System (AIS) at Higher Pressure
Keywords
Malignant Neoplasms of Female Genital Organs, Laparoscopic gynecologic surgery, Robotic gynecologic surgery, AirSeal® Insufflation System, AIS, Conventional Insufflation System, CIS, Questionnaires, Surveys

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesBehavioural

    Also called Surveys

    Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge.

    Questionnaires ask about pain level and any drugs taken for it. It should take about 5 minutes to complete.

  • Conventional Insufflation System (CIS)Device

    Also called CIS

    CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

  • ConMed AirSeal Insufflation System (AIS) at Low PressureDevice

    Also called AIS

    AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

  • ConMed AirSeal Insufflation System (AIS) at Higher PressureDevice

    Also called AIS

    AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

Study groups in NCT03128281
Study groupRoleWhat they receive
Conventional Insufflation System (CIS)ExperimentalQuestionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. Conventional Insufflation System (CIS) used for pneumoperitoneum during laparoscopic/robotic surgery.
Receives: Behavioral: Questionnaires; Device: Conventional Insufflation System (CIS)
ConMed AirSeal Insufflation System (AIS) at Low PressureExperimentalQuestionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Low Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.
Receives: Behavioral: Questionnaires; Device: ConMed AirSeal Insufflation System (AIS) at Low Pressure
ConMed AirSeal Insufflation System (AIS) at Higher PressureActive comparatorQuestionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge. ConMed AirSeal Insufflation System (AIS) at Higher Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.
Receives: Behavioral: Questionnaires; Device: ConMed AirSeal Insufflation System (AIS) at Higher Pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery

    Incidence of shoulder pain defined by a positive (>0) score for an 11-point pain intensity numeric rating scale (PI-NRS).

    Measured: Post-operative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study startJul 2018 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2022 (estimated)

Why it stopped: Sponsor issue

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03128281
Sponsor's protocol ID
2015-0973
Other IDs
NCI-2018-01330
Status last verified
May 2019
First submitted
20 Apr 2017
Last updated
30 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Questionnaires, Conventional Insufflation System (CIS) and ConMed AirSeal Insufflation System (AIS) at Low Pressure in people with Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center.

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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 30 May 2019. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery (time frame: Post-operative day 1). 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 NCT03128281.

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 30 May 2019.

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