Ultralow Versus Standard Pneumoperitoneum Pressure

NCT03630393 | Terminated Results

• 1 other identifier: 1306218
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostatectomy; Robotic; Urology

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Medication Use

  The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.

  Through 1 week postoperatively

Secondary Outcomes (3)

• Post Operative Pain Scores

  Through discharge (post-operative day 0 or post-operative day 1)

• Operative Ventilation

  Intraoperatively

• Discharge Day (Post-operative Day 0 or 1)

  Through discharge (post-operative day 0 or 1)

Study Arms (2)

Pressure 6 mmHg

EXPERIMENTAL

Pneumoperitoneum Pressure 6 mmHg

Other: Pneumoperitoneum Pressure 6 mmHg

Pressure 15 mmHg

ACTIVE COMPARATOR

Pneumoperitoneum Pressure 15 mmHg

Other: Pneumoperitoneum Pressure 15 mmHg

Interventions

Pneumoperitoneum Pressure 6 mmHg OTHER

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

Pressure 6 mmHg

Pneumoperitoneum Pressure 15 mmHg OTHER

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

Pressure 15 mmHg

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with prostate cancer who are eligible and electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Diagnosed with prostate cancer
• Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)

You may not qualify if:

• Age \< 18
• Emergency surgery
• Patients with a significant preoperative dependence on narcotic medications
• Unable to give informed consent
• Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
• 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)
• Non-English-speaking or reading

Sponsors & Collaborators

• OhioHealth: lead
• CONMED Corporation: collaborator

Study Sites (1)

Dublin Methodist Hospital

Columbus, Ohio, 43016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ryan Hedgepeth
• Organization: OhioHealth

ryan.hedgepeth@ohiohealth.com

614-788-2870

Study Officials

• Ronney Abaza, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 14, 2018
• Study Start: May 9, 2019
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: February 18, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)