Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System (AIRSEAL)

  • STATUS
    Recruiting
  • End date
    Jan 22, 2023
  • participants needed
    80
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 26 February 2022

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. 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).

Details
Condition Laparoscopic Hysterectomy
Treatment Airseal®, Standard insufflator
Clinical Study IdentifierNCT03418402
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note