NCT02853591

Brief Summary

This study seeks to evaluate post-operative patient pain and quality of life, and intra-operative hemodynamic status and changes in inflammatory markers, with use of a pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum pressure settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

5.2 years

First QC Date

July 26, 2016

Last Update Submit

March 6, 2023

Conditions

PainPneumoperitoneumInflammationQuality of Life

Keywords

laparoscopyhysterectomy

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Numerical rating scale

    2 hours post-surgery

Secondary Outcomes (26)

  • Pain score on a NRS

    1 day post-surgery

  • Narcotic usage

    2 hours and 1 day post-surgery

  • Heart rate

    Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release

  • Mean arterial pressure

    Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release

  • Total peripheral resistance

    Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release

  • +21 more secondary outcomes

Study Arms (4)

Standard High Pressure (15mmHg)

ACTIVE COMPARATOR

Pneumoinsufflator mode and setting: standard at 15mmHg

Procedure: Pneumoinsufflator mode and setting

AirSeal High Pressure (15mmHg)

EXPERIMENTAL

Pneumoinsufflator mode and setting: pressure-barrier at 15mmHg

Procedure: Pneumoinsufflator mode and setting

Standard Low Pressure (9mmHg)

EXPERIMENTAL

Pneumoinsufflator mode and setting: standard at 9mmHg

Procedure: Pneumoinsufflator mode and setting

AirSeal Low Pressure (9mmHg)

EXPERIMENTAL

Pneumoinsufflator mode and setting: pressure-barrier at 9 mmHg

Procedure: Pneumoinsufflator mode and setting

Interventions

Pneumoinsufflator mode and settingPROCEDURE

Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.

Also known as: Intra-abdominal pressure
AirSeal High Pressure (15mmHg)AirSeal Low Pressure (9mmHg)Standard High Pressure (15mmHg)Standard Low Pressure (9mmHg)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and voluntarily sign an informed consent form.
  • Female gender ages 18-65
  • Scheduled for total laparoscopic hysterectomy for benign indications with or without oophorectomy (standard of care involves bilateral salpingectomy).

You may not qualify if:

  • Anticipated removal of uterus through any route except vagina (transvaginal morcellation is acceptable)
  • Planned concomitant procedures including but not limited to resection of deep endometriosis, plastic surgery procedures, or bowel resection.
  • Daily narcotic pain medication use for greater than 30 days leading into surgery
  • Use of da Vinci® robot surgical assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

PainPneumoperitoneumInflammation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeritoneal DiseasesDigestive System DiseasesPathologic Processes

Study Officials

  • Stephen Zimberg, MD

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

  • Pamela Frazzini Padilla, MD

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 3, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)