LaPAroscopic Low pRessure cOlorectal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2020-06-26

Brief Summary

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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.

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Detailed Description

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This research focuses on a medical device that allows the surgeon to perform the surgical procedure at a lower pressure than usual.

The main objective of this study is to compare the duration of hospitalization of patients with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg) It is a prospective randomized monocentric double blind study

Conditions

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Malignant or Benign Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Arm A: Low Pressure (5-7 mmHg)

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

Group Type EXPERIMENTAL

Airseal®

Intervention Type DEVICE

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

Arm B: Standard pressure (12-15 mmHg)

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

Group Type ACTIVE_COMPARATOR

Standard Insufflation

Intervention Type DEVICE

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

Interventions

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Airseal®

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

Intervention Type DEVICE

Standard Insufflation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No