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

Study Overview
=================
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)

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

Conditions
-----------------
Gynaecologic Cancer

Intervention / Treatment
-----------------
* Procedure: Drain
* Procedure: Manual exsufflation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A :Aspiration of peritoneal gas through a drain<br>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. | Procedure: Drain<br>* A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).<br>|
| Active Comparator: Arm B : Manual evacuation of the peritoneal gas, via the trocar<br>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. | Procedure: Manual exsufflation<br>* Exsufflation through the trocar opening.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests). | During the 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10) | The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests). | 24 hours after surgery | 
| Assess pain at trocar holes comparatively in the two groups | The site of pain will be reported to describe pain overall, but also specifically in the shoulders and/or subcostal areas and pain at trocar holes. Pain will be measured with the numerical pain assessment scale (score from 0 to 10). | 24 hours after surgery | 
| Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10) | A notebook filled in by the patient at home with a daily assessment of pain according to the numerical pain assessment scale, with a phone call from the nurse on day 7 (considering that the day of the surgery is day 0). | 7 days after surgery | 
| Antalgics consumption | Qualitative description through patient notebook. | 24 hours and 7 days after surgery | 
| Antalgics consumption | Quantitative description through patient notebook. | 24 hours and 7 days after surgery | 
| Adverse events (AE) (grade ≥III Clavien-Dindo classification) | Safety procedure will be describe through adverse events notification potentially related to the procedure and their grade (total amount of AE, maximal grade of AE per patient). | 30 days after surgery | 
| Evaluate the impact of the evaluated procedure on the hospitalisation duration | Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery. | Through the study patient participation, an average of 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, Peritoneal gas drainage, Laparoscopic gynaecological surgery, Robotised laparoscopic gynaecological surgery