Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Mini… (NCT04974125) | Clinical Trial Compass
CompletedNot Applicable
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery
France202 participantsStarted 2022-01-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)