LaPAroscopic Low pRessure cOlorectal Surgery (PAROS)

University Hospital of Bordeaux

Status: Completed

Conditions: Malignant or Benign Pathology

Treatments: Device: Airseal®; Device: Standard Insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT03813797

CHUBX 2018/42

Details and patient eligibility

About

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.

Full description

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

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Arm A: Low Pressure (5-7 mmHg)

Experimental group

Description:

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

Treatment:

Device: Airseal®

Arm B: Standard pressure (12-15 mmHg)

Active Comparator group

Description:

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

Treatment:

Device: Standard Insufflation