Back to resultsImpact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery (DRAIN-EXSU)
Primary Purpose
Gynaecologic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Drain
Manual exsufflation
Sponsored by
About this trial
This is an interventional other trial for Gynaecologic Cancer focused on measuring Postoperative pain, Peritoneal gas drainage, Laparoscopic gynaecological surgery, Robotised laparoscopic gynaecological surgery
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
Sites / Locations
- Fabrice NARDUCCIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A :Aspiration of peritoneal gas through a drain
Arm B : Manual evacuation of the peritoneal gas, via the trocar
Arm 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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Antalgics consumption
Qualitative description through patient notebook.
Antalgics consumption
Quantitative description through patient notebook.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974125
Brief Title
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery
Acronym
DRAIN-EXSU
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynaecologic Cancer
Keywords
Postoperative pain, Peritoneal gas drainage, Laparoscopic gynaecological surgery, Robotised laparoscopic gynaecological surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A :Aspiration of peritoneal gas through a drain
Arm Type
Experimental
Arm 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.
Arm Title
Arm B : Manual evacuation of the peritoneal gas, via the trocar
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Drain
Intervention Description
A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
Intervention Type
Procedure
Intervention Name(s)
Manual exsufflation
Intervention Description
Exsufflation through the trocar opening.
Primary Outcome Measure Information:
Title
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)
Description
Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).
Time Frame
During the 24 hours after surgery
Secondary Outcome Measure Information:
Title
Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10)
Description
The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests).
Time Frame
24 hours after surgery
Title
Assess pain at trocar holes comparatively in the two groups
Description
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).
Time Frame
24 hours after surgery
Title
Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10)
Description
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).
Time Frame
7 days after surgery
Title
Antalgics consumption
Description
Qualitative description through patient notebook.
Time Frame
24 hours and 7 days after surgery
Title
Antalgics consumption
Description
Quantitative description through patient notebook.
Time Frame
24 hours and 7 days after surgery
Title
Adverse events (AE) (grade ≥III Clavien-Dindo classification)
Description
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).
Time Frame
30 days after surgery
Title
Evaluate the impact of the evaluated procedure on the hospitalisation duration
Description
Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery.
Time Frame
Through the study patient participation, an average of 2 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gynaecological cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny BEN OUNE
Phone
+33320295918
Email
promotion@o-lambret.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice MULOT
Phone
+33320295918
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice NARDUCCI, PhD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
Facility Information:
Facility Name
Fabrice NARDUCCI
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice NARDUCCI, PhD
Email
f-narducci@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Fabrice NARDUCCI, PhD
12. IPD Sharing Statement
Learn more about this trial
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery
We'll reach out to this number within 24 hrs