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

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.

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)

Inclusion Criteria:

• Age ≥ 18 ans ;
• Woman who underwent laparoscopic or robotised laparoscopic surgery in peritoneal cavity (benign or malignant gynaecological affection) ;
• Planned ambulatory surgery
• Patient willing and able to be treated and followed according the protocol during the trial ;
• Patient covered by the French "Social Security" regime ;
• Effective contraception for reproductive age patients ;
• Signed written informed consent before surgery

Per-operatory eligibility criterion :

• No conversion from laparoscopic surgery to laparotomy surgery

Exclusion Criteria:

• Extra-peritoneal surgery scheduled ( example : aortic dissection) ;
• Upper-abdomen surgery (example : liver, gall bladder) ;
• History of shoulders pains prior to surgery (the assessment must be carried out within a period of 30 days before the surgery) ;
• Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
• Person under guardianship
• Pregnant or breastfeeding woman

Non eligibility criterion known during the operation :

• Conversion from laparoscopic surgery to laparotomy surgery