Ultralow Versus Standard Pneumoperitoneum Pressure

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2021-02-10

Brief Summary

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The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.

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Detailed Description

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The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pressure 6 mmHg

Pneumoperitoneum Pressure 6 mmHg

Group Type EXPERIMENTAL

Pneumoperitoneum Pressure 6 mmHg

Intervention Type OTHER

A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Pressure 15 mmHg

Pneumoperitoneum Pressure 15 mmHg

Group Type ACTIVE_COMPARATOR

Pneumoperitoneum Pressure 15 mmHg

Intervention Type OTHER

A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Interventions

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Pneumoperitoneum Pressure 6 mmHg

A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Intervention Type OTHER

Pneumoperitoneum Pressure 15 mmHg

A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older
2. Diagnosed with prostate cancer
3. Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)

Exclusion Criteria

1. Age \< 18
2. Emergency surgery
3. Patients with a significant preoperative dependence on narcotic medications
4. Unable to give informed consent
5. Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
6. Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)
7. Non-English-speaking or reading

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No