NCT04112654

Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.

Conditions

• Colonic Disease

Interventions

Type	Name	Description
PROCEDURE	Conventional pressure laparoscopy	Conventional pressure laparoscopy using conventional insufflator AirSeal®
PROCEDURE	Low pressure laparoscopy	Low pressure laparoscopy using pressure-controlled insufflator AirSeal®

Timeline

• Start date: 2020-06-29
• Primary completion: 2023-06-07
• Completion: 2023-10-18
• First posted: 2019-10-02
• Last updated: 2024-04-09

Locations

1 site across 1 country: France