Clinical trial NCT03128281: Pneumoperitoneum Management With Low vs. Higher Pressure
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Malignant Neoplasms of Female Genital Organs
Keywords: Malignant Neoplasms of Female Genital Organs
Laparoscopic gynecologic surgery
Robotic gynecologic surgery
AirSeal® Insufflation System
AIS
Conventional Insufflation System
CIS
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: CONMED Corporation
First posted: 2017-04-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). "Insufflation" is the creation of a pressure barrier of air/gas within the abdomen that allows the surgeon more space to work in.

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.

Eligibility criteria: Inclusion Criteria:

1. All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
2. 18-80 years of age
3. Capable and willing to provide Informed consent
4. Acceptable candidate for laparoscopic/robotic GYN surgery as per discretion of the surgeon
5. 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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery
timeFrame: Post-operative day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Pedro T. Ramirez, MD
role: PRINCIPAL_INVESTIGATOR
References: