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

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.

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 Overview

• Status: Completed
• Conditions: Laparoscopic Hysterectomy
• Intervention / Treatment: Device: Airseal®; Device: Standard insufflator

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Airseal®; Low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum.	Device: Airseal®; Total laparoscopic hysterectomy: Approach according to the Open-Laparoscopy technique and use of the insufflation system.
ACTIVE_COMPARATOR: Standard insufflator; laparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum.	Device: Standard insufflator; Standard insufflator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six hours

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2018
• Primary Completion (ACTUAL): June 11, 2020
• Study Completion (ACTUAL): July 8, 2020

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2017-27; 2017-A01640-53 (REGISTRY: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No