Laparoscopic HysterectomyAIRSEALNCT03418402
Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System
A study testing Airseal® and Standard insufflator in people with Laparoscopic Hysterectomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Airseal® is an insufflation management system for laparoscopic surgery which provides stable pneumoperitoneum, continuous smoke evacuation and valve-free access to the abdominal cavity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Airseal® and Standard insufflator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to 8 Jul 2020
- 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
- Patients at least 18 years old.
- Patients who agreed to participate in the study and signed informed consent.
- Surgical indication by laparoscopy of total interadnexal hysterectomy or associated with unilateral or bilateral adnexectomy, for benign pathology, without any other associated surgical procedure.
- Absence of contraindications to the taking of analgesics provided for in the standardized protocols of analgesia per and post-operative.
Who cannot join
- Patients at least 18 years old.
- Patients who agreed to participate in the study and signed informed consent.
- Surgical indication by laparoscopy of total interadnexal hysterectomy or associated with unilateral or bilateral adnexectomy, for benign pathology, without any other associated surgical procedure.
- Absence of contraindications to the taking of analgesics provided for in the standardized protocols of analgesia per and post-operative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System: A Randomized Prospective Study
Airseal® is an insufflation management system for laparoscopic surgery which provides stable pneumoperitoneum, continuous smoke evacuation and valve-free access to the abdominal cavity. It allows an optimal exposure with a low-pression pneumoperitoneum, which is rarely possible with our standard insufflation system under a pneumoperitoneum of 12 millimetres of mercury(mmHg).
The objective of this study is to compare the use of Airseal® system with a low pression pneumoperitoneum and our standard insufflation system usually used in our center in term of postoperative abdominal pain after laparoscopic hysterectomy for benign disease.
Read more
This superiority prospective randomized trial is designed to include all patients > 18 years old referred for laparoscopic total hysterectomy for benign disease (with or without uni or bilateral annexectomy). Each patient would be randomized to one of this two following groups :
- " Airseal® " group : use of AIRSEAL® to obtain stable low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum.
- " Standard laparoscopy " group : laparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum.
The primary end point is mean intensity of abdominal pain six hours after the end of surgery (H6), measured by simple numerical scale (ENS).
The secondary end points are:
- peroperative endpoints : operative time, blood loss, use of additional ways of increasing exposure, peroperative complications, conversion to laparotomy, feeling of the surgeon regarding the difficulty of the surgery (measured by a simple numerical scale)
- early postoperative endpoints : intensity of abdominal pain at the entry in recovery room (H0), at twelve hours after the end of surgery (H12), twenty four hours (H24) and forty eight hours (H48) ; intensity of scapular pain at the same times (H0, H6, H12, H24 and H48), need for analgesic administration (regarding to the standardized analgesic protocol), difference in the hemoglobin level before surgery and the first day after, early postoperative complications, necessity of a second surgery and the reason, length of hospital stay.
- late postoperative end points : estimated time to return to optimal quality of life, global satisfaction of patients evaluated by the Quality Of Life Questionnaire Short Form 12.
It will be estimate that the use of Airseal® will reduce the mean abdominal pain at H6 post operative of 1 point on the simple numerical scale compared to our standard insufflation system, with a standard deviation of 1,5. Type 1 and 2 errors were set to the usual levels of 0,05 and 0,20 respectively (power of 80%). Assuming a 10% withdrawal rate, the sample size would be 80 patients (40 patients in each group).
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Airseal®, Standard insufflator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airseal®Device
Total laparoscopic hysterectomy: Approach according to the Open-Laparoscopy technique and use of the insufflation system.
Standard insufflatorDevice
Standard insufflator
| Study group | Role | What they receive |
|---|---|---|
| Airseal® | Experimental | Low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum. Receives: Device: Airseal® |
| Standard insufflator | Active comparator | laparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum. Receives: Device: Standard insufflator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain by simple numerical scale
The primary end point is mean intensity of abdominal pain measured by simple numerical scale. a score of 0 to 10 best describes the importance of the patient's pain. The score 0 corresponds to "no pain". Note 10 is the maximum "pain" imaginable
Measured: six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start8 Feb 2018
- Primary completion11 Jun 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418402
- Sponsor's protocol ID
- 2017-27
- Other IDs
- 2017-A01640-53
- Acronym
- AIRSEAL
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2018
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delecourt C, Tourette C, Crochet P, Pivano A, Hamouda I, Agostini A. Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2022 Aug;29(8):1003-1010. doi: 10.1016/j.jmig.2022.05.005. Epub 2022 May 13.
PubMed 35569811
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03418402
- Acronym / sponsor ID
- AIRSEAL / 2017-27
- Conditions
- Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 1 Feb 2018 (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.
Airseal® is an insufflation management system for laparoscopic surgery which provides stable pneumoperitoneum, continuous smoke evacuation and valve-free access to the abdominal cavity. It allows an optimal exposure with a low-pression pneumoperitoneum, which is rarely possible with our standard insufflation system under a pneumoperitoneum of 12 millimetres of mercury(mmHg).
The objective of this study is to compare the use of Airseal® system with a low pression pneumoperitoneum and our standard insufflation system usually used in our center in term of postoperative abdominal pain after laparoscopic hysterectomy for benign disease.
This superiority prospective randomized trial is designed to include all patients > 18 years old referred for laparoscopic total hysterectomy for benign disease (with or without uni or bilateral annexectomy). Each patient would be randomized to one of this two following groups :
- " Airseal® " group : use of AIRSEAL® to obtain stable low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum.
- " Standard laparoscopy " group : laparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum.
The primary end point is mean intensity of abdominal pain six hours after the end of surgery (H6), measured by simple numerical scale (ENS).
The secondary end points are:
- peroperative endpoints : operative time, blood loss, use of additional ways of increasing exposure, peroperative complications, conversion to laparotomy, feeling of the surgeon regarding the difficulty of the surgery (measured by a simple numerical scale)
- early postoperative endpoints : intensity of abdominal pain at the entry in recovery room (H0), at twelve hours after the end of surgery (H12), twenty four hours (H24) and forty eight hours (H48) ; intensity of scapular pain at the same times (H0, H6, H12, H24 and H48), need for analgesic administration (regarding to the standardized analgesic protocol), difference in the hemoglobin level before surgery and the first day after, early postoperative complications, necessity of a second surgery and the reason, length of hospital stay.
- late postoperative end points : estimated time to return to optimal quality of life, global satisfaction of patients evaluated by the Quality Of Life Questionnaire Short Form 12.
It will be estimate that the use of Airseal® will reduce the mean abdominal pain at H6 post operative of 1 point on the simple numerical scale compared to our standard insufflation system, with a standard deviation of 1,5. Type 1 and 2 errors were set to the usual levels of 0,05 and 0,20 respectively (power of 80%). Assuming a 10% withdrawal rate, the sample size would be 80 patients (40 patients in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airseal® | Experimental | Device: Airseal®Low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum. |
| Standard insufflator | Active comparator | Device: Standard insufflatorlaparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 18 years old.
- Patients who agreed to participate in the study and signed informed consent.
- Surgical indication by laparoscopy of total interadnexal hysterectomy or associated with unilateral or bilateral adnexectomy, for benign pathology, without any other associated surgical procedure.
- Absence of contraindications to the taking of analgesics provided for in the standardized protocols of analgesia per and post-operative.
Key exclusion criteria (4 listed)
- Patients at least 18 years old.
- Patients who agreed to participate in the study and signed informed consent.
- Surgical indication by laparoscopy of total interadnexal hysterectomy or associated with unilateral or bilateral adnexectomy, for benign pathology, without any other associated surgical procedure.
- Absence of contraindications to the taking of analgesics provided for in the standardized protocols of analgesia per and post-operative.
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 |
|---|---|---|
| Airseal®Total laparoscopic hysterectomy: Approach according to the Open-Laparoscopy technique and use of the insufflation system. | Device | Airseal® |
| Standard insufflatorStandard insufflator | Device | Standard insufflator |
Primary outcome
Assessment of pain by simple numerical scale
Time frame: six hours
The primary end point is mean intensity of abdominal pain measured by simple numerical scale. a score of 0 to 10 best describes the importance of the patient's pain. The score 0 corresponds to "no pain". Note 10 is the maximum "pain" imaginable
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 8 May 2026.
- Results publication: PubMed 35569811Delecourt C, Tourette C, Crochet P, Pivano A, Hamouda I, Agostini A. Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2022 Aug;29(8):1003-1010. doi: 10.1016/j.jmig.2022.05.005. Epub 2022 May 13.
Related trials for Laparoscopic Hysterectomy
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Not yet recruiting
27-Inch Versus 55-Inch Monitors in Women Undergoing Endometrial Cancer Surgery
Endometrial Cancer
RecruitingPhase 4
Preoperative Acetazolamide
Post Operative Pain, Laparoscopic Hysterectomy
Not yet recruiting
LapBox® Manual Containment System
Surgery
Recruiting
Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
Hysterectomy, Vaginal
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.
Jean-Olivier ARNAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airseal® and Standard insufflator in people with Laparoscopic Hysterectomy, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 4 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 8 May 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?
Assessment of pain by simple numerical scale (time frame: six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418402, which also lists 1 linked publication.
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 8 May 2026.