NCT03813797

LaPAroscopic Low pRessure cOlorectal Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Malignant or Benign Pathology

Interventions

Type	Name	Description
DEVICE	Airseal®	Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
DEVICE	Standard Insufflation	Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg

Timeline

• Start date: 2019-01-07
• Primary completion: 2020-05-25
• Completion: 2020-06-26
• First posted: 2019-01-23
• Last updated: 2020-10-08

Locations

1 site across 1 country: France