NCT04974125

Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery

Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. This study aim is to assess the efficacy of active gas extraction with a drain (arm A) in comparison to manual evacuation (arm B,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.

Detailed description

The primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain. Secondary objectives of this study include : * Comparing the evolution of specific pains after laparoscopic surgery, between study groups * Description of postoperative antalgics consumption in each group * Evaluating the safety of the evaluated procedure * Evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)

Conditions

• Gynaecologic Cancer

Interventions

Type	Name	Description
PROCEDURE	Drain	A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
PROCEDURE	Manual exsufflation	Exsufflation through the trocar opening.

Timeline

• Start date: 2022-01-07
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2021-07-23
• Last updated: 2026-03-18

Locations

1 site across 1 country: France