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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03813797
Study type Interventional
Source University Hospital, Bordeaux
Contact
Status Completed
Phase N/A
Start date January 7, 2019
Completion date June 26, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04742881 - Low Impact Laparoscopic in Colorectal Resection - PAROS2 N/A