Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery (DRAIN-EXSU)

Centre Oscar Lambret

Status: Completed

Conditions: Gynaecologic Cancer

Treatments: Procedure: Manual exsufflation; Procedure: Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT04974125

DRAIN-EXSU-1907

Details and patient eligibility

About

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.

Full 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)

Enrollment: 202 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

202 participants in 2 patient groups

Arm A :Aspiration of peritoneal gas through a drain

Experimental group

Description:

Patients in experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out by a drain. Then, patients will be followed-up during 7 days after surgery.

Treatment:

Procedure: Drain

Arm B : Manual evacuation of the peritoneal gas, via the trocar

Active Comparator group

Description:

Laparoscopic or robotised laparoscopic surgery + Trocar Patient in this experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out carried out manually using the trocar (standard of care).Then, patient will be followed-up during 7 days after surgery.

Treatment:

Procedure: Manual exsufflation