Clinical trial NCT04974125: Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery
Official title: Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynaecologic Cancer
Keywords: Postoperative pain
Peritoneal gas drainage
Laparoscopic gynaecological surgery
Robotised laparoscopic gynaecological surgery
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be pre-selected before medical operation. During the surgery, if the surgeon performs only the laparoscopy, the patient will be randomized. Then, the allocated procedure (with or without drain) will be carried out.
Primary purpose: OTHER

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Specific pain (shoulders and/or subcostal areas) related to the laparoscopic surgery (Day 0), measured with a numerical pain assessment scale (score from 0 to 10)
timeFrame: During the 24 hours after surgery
Secondary outcomes:
measure: Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10)
timeFrame: 24 hours after surgery
measure: Assess pain at trocar holes comparatively in the two groups
timeFrame: 24 hours after surgery
measure: Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10)
timeFrame: 7 days after surgery
measure: Antalgics consumption
timeFrame: 24 hours and 7 days after surgery
measure: Antalgics consumption
timeFrame: 24 hours and 7 days after surgery
measure: Adverse events (AE) (grade ≥III Clavien-Dindo classification)
timeFrame: 30 days after surgery
measure: Evaluate the impact of the evaluated procedure on the hospitalisation duration
timeFrame: Through the study patient participation, an average of 2 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Fabrice NARDUCCI
Study officials:
affiliation: Centre Oscar Lambret
name: Fabrice NARDUCCI, PhD
role: STUDY_DIRECTOR
References: