NCT03813797

Brief Summary

Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of Airseal, working at 7mmHg was not possible because the space of work was not stable. Moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

January 8, 2019

Last Update Submit

October 6, 2020

Conditions

Malignant or Benign Pathology

Keywords

Low PressureLaparoscopyColectomyPneumoperitoneumAirSeal

Outcome Measures

Primary Outcomes (1)

  • Length of postoperative hospital stay

    To determine the length of hospitalization

    From surgery to the end of the hospitalization (max 30 days)

Secondary Outcomes (18)

  • Surgery time

    During surgery

  • Appreciation of visual quality by surgeon

    During surgery

  • Impact of the use of microlaparoscopic instruments

    During surgery

  • Rates of conversion

    During surgery

  • Blood pressure (mmHg)

    During surgery

  • +13 more secondary outcomes

Study Arms (2)

Arm A: Low Pressure (5-7 mmHg)

EXPERIMENTAL

Laparoscopic colectomy surgery with low pressure (5-7mmHg)

Device: Airseal®

Arm B: Standard pressure (12-15 mmHg)

ACTIVE COMPARATOR

Laparoscopic colectomy surgery with standard pressure (12-15mmHg)

Device: Standard Insufflation

Interventions

Airseal®DEVICE

Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg

Arm A: Low Pressure (5-7 mmHg)
Standard InsufflationDEVICE

Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg

Arm B: Standard pressure (12-15 mmHg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Colonic resection (right or left) performed for benign or malignant pathology
  • Laparoscopic procedure
  • Informed consent signed
  • Social Insurance

You may not qualify if:

  • Laparotomy procedure
  • Associated resection (except appendectomy or liver biopsy
  • Emergency procedure
  • Pelvic sepsis
  • Pregnant or breast-feeding woman.
  • Persons deprived of liberty or under guardianship
  • Impossibility for compliance to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Bordeaux

Bordeaux, France

Location

Related Publications (1)

  • Celarier S, Monziols S, Celerier B, Assenat V, Carles P, Napolitano G, Laclau-Lacrouts M, Rullier E, Ouattara A, Denost Q. Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial. Br J Surg. 2021 Aug 19;108(8):998-1005. doi: 10.1093/bjs/znab069.

    PMID: 33755088DERIVED

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Quentin DENOST

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The study will be carried out: * Blind patient: The patient will not know the group he belongs to, in order to minimize the bias related to the self-evaluation of postoperative pain * Blind for the outpatient evaluator: the surgeon will blindly evaluate the primary endpoint: patient's discharge criteria. This "evaluator" surgeon will be different from the "operator" surgeon The blind will minimize the measurement bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 23, 2019

Study Start

January 7, 2019

Primary Completion

May 25, 2020

Study Completion

June 26, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)