Gynaecologic CancerDRAIN-EXSUNCT04974125
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery
A study testing Drain and Manual exsufflation in people with Gynaecologic Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecologic Cancer
- What is being tested?
- Drain and Manual exsufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2022to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
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- Signed written informed consent before surgery
- Per-operatory eligibility criterion :
- No conversion from laparoscopic surgery to laparotomy surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
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.
Read the 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)
- Conditions
- Gynaecologic Cancer
- Being tested
- Drain, Manual exsufflation
- Keywords
- Postoperative pain, Peritoneal gas drainage, Laparoscopic gynaecological surgery, Robotised laparoscopic gynaecological surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainProcedure or surgery
A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
Manual exsufflationProcedure or surgery
Exsufflation through the trocar opening.
| Study group | Role | What they receive |
|---|---|---|
| Arm A :Aspiration of peritoneal gas through a drain | Experimental | 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. Receives: Procedure: Drain |
| Arm B : Manual evacuation of the peritoneal gas, via the trocar | Active comparator | 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. Receives: Procedure: Manual exsufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the 24 hours after surgery
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 7 days after surgery
Antalgics consumption
Qualitative description through patient notebook.
Measured: 24 hours and 7 days after surgery
Antalgics consumption
Quantitative description through patient notebook.
Measured: 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).
Measured: 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.
Measured: Through the study patient participation, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start7 Jan 2022
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice NARDUCCI, PhD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974125
- Sponsor's protocol ID
- DRAIN-EXSU-1907
- Other IDs
- 2021-A00602-39
- Acronym
- DRAIN-EXSU
- Status last verified
- Mar 2026
- First submitted
- 6 May 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT04974125
- Acronym / sponsor ID
- DRAIN-EXSU / DRAIN-EXSU-1907
- Conditions
- Gynaecologic Cancer
- Keywords
- Postoperative pain, Peritoneal gas drainage, Laparoscopic gynaecological surgery, Robotised laparoscopic gynaecological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A :Aspiration of peritoneal gas through a drain | Experimental | Procedure: DrainPatients 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 B : Manual evacuation of the peritoneal gas, via the trocar | Active comparator | Procedure: Manual exsufflationLaparoscopic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 ;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrainA 10 mm suction drain is placed through a trocar in the right hypochondrium (liver). | Procedure or surgery | Arm A :Aspiration of peritoneal gas through a drain |
| Manual exsufflationExsufflation through the trocar opening. | Procedure or surgery | Arm B : Manual evacuation of the peritoneal gas, via the trocar |
Primary outcome
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)
Time frame: During the 24 hours after surgery
Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).
7 secondary outcomes
Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10)
Time frame: 24 hours after surgery
Assess pain at trocar holes comparatively in the two groups
Time frame: 24 hours after surgery
Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10)
Time frame: 7 days after surgery
Antalgics consumption
Time frame: 24 hours and 7 days after surgery
Antalgics consumption
Time frame: 24 hours and 7 days after surgery
Adverse events (AE) (grade ≥III Clavien-Dindo classification)
Time frame: 30 days after surgery
Evaluate the impact of the evaluated procedure on the hospitalisation duration
Time frame: Through the study patient participation, an average of 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice NARDUCCI, PhD study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain and Manual exsufflation in people with Gynaecologic Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: During the 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.