Pneumoperitoneum Management With Low vs. Higher Pressure

Phase 2

Withdrawn

• Conditions: Malignant Neoplasms of Female Genital Organs
• Interventions: Behavioral: Questionnaires; Device: ConMed AirSeal Insufflation System (AIS) at Low Pressure; Device: Conventional Insufflation System (CIS); Device: ConMed AirSeal Insufflation System (AIS) at Higher Pressure

• Registration Number: NCT03128281
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-25
• Study Start: 2018-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-30
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ConMed AirSeal Insufflation System (AIS) at Low Pressure	Questionnaires	Questionnaires 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.
ConMed AirSeal Insufflation System (AIS) at Low Pressure	ConMed AirSeal Insufflation System (AIS) at Low Pressure	Questionnaires 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.
ConMed AirSeal Insufflation System (AIS) at Higher Pressure	Questionnaires	Questionnaires 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.
Conventional Insufflation System (CIS)	Questionnaires	Questionnaires 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.
Conventional Insufflation System (CIS)	Conventional Insufflation System (CIS)	Questionnaires 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.
ConMed AirSeal Insufflation System (AIS) at Higher Pressure	ConMed AirSeal Insufflation System (AIS) at Higher Pressure	Questionnaires 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.

Primary Outcome Measures

Name	Time	Method
Incidence of Shoulder Pain After Laparoscopic/Robotic Surgery	Post-operative day 1	Incidence of shoulder pain defined by a positive (\>0) score for an 11-point pain intensity numeric rating scale (PI-NRS).