Low Impact Laparoscopy Concept Versus Conventional Laparoscopy
NCT ID: NCT04165148
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2020-06-03
2023-09-03
Brief Summary
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The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain.
The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased.
The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy.
The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the Intelligent Flow System (iFS) AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the iFS AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
Visual Analog Scale (VAS) for Pain
The patient evaluates her pain using an VAS scale on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with VAS scale) will be collected.
During the usual consultation at 1 month, the patient must evaluate her pain by means of an VAS.
Saint-Antoine Pain Questionnaire (QDSA)
The patient evaluates her pain using an QDSA questionnaire on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with QDSA questionnaire) will be collected.
During the usual consultation at 1 month, the patient must evaluate her pain by means of an QDSA questionnaire.
post-operative questionnaire
The patient will fill in the antalgic intake record and the patient booklet for the collection of medical consumptions from her discharge from the hospital and during the month following the surgery.
conventional laparoscopy
conventional laparoscopy
conventional laparoscopy
conventional laparoscopy
Visual Analog Scale (VAS) for Pain
The patient evaluates her pain using an VAS scale on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with VAS scale) will be collected.
During the usual consultation at 1 month, the patient must evaluate her pain by means of an VAS.
Saint-Antoine Pain Questionnaire (QDSA)
The patient evaluates her pain using an QDSA questionnaire on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with QDSA questionnaire) will be collected.
During the usual consultation at 1 month, the patient must evaluate her pain by means of an QDSA questionnaire.
post-operative questionnaire
The patient will fill in the antalgic intake record and the patient booklet for the collection of medical consumptions from her discharge from the hospital and during the month following the surgery.
Interventions
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Low Impact Laparoscopy
Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the iFS AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
conventional laparoscopy
conventional laparoscopy
Visual Analog Scale (VAS) for Pain
The patient evaluates her pain using an VAS scale on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with VAS scale) will be collected.
During the usual consultation at 1 month, the patient must evaluate her pain by means of an VAS.
Saint-Antoine Pain Questionnaire (QDSA)
The patient evaluates her pain using an QDSA questionnaire on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with QDSA questionnaire) will be collected.
During the usual consultation at 1 month, the patient must evaluate her pain by means of an QDSA questionnaire.
post-operative questionnaire
The patient will fill in the antalgic intake record and the patient booklet for the collection of medical consumptions from her discharge from the hospital and during the month following the surgery.
Eligibility Criteria
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Inclusion Criteria
* planned surgery procedure : ambulatory laparoscopic hysterectomy
* effective contraception if women of childbearing age
* patients with free, informed and signed consent
Exclusion Criteria
* pregnancy or wish for subsequent pregnancy
* lactating women
* contraindication to laparoscopy
* contraindication to minimally invasive endoscopic techniques
* not eligible for outpatient care
* inability to understand the information given
* a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Femme Mère Enfant
Bron, , France
Countries
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Other Identifiers
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2019-A01863-54
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL19_0335
Identifier Type: -
Identifier Source: org_study_id
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