Ambulatory Laparoscopic HysterectomyRANDOLILNCT04165148
Low Impact Laparoscopy Concept Versus Conventional Laparoscopy
A study testing Low Impact Laparoscopy, conventional laparoscopy and Visual Analog Scale (VAS) for Pain in people with Ambulatory Laparoscopic Hysterectomy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ambulatory Laparoscopic Hysterectomy
- What is being tested?
- Low Impact Laparoscopy, conventional laparoscopy and Visual Analog Scale (VAS) for Pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2020to 3 Sep 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
- women over 18 years
- planned surgery procedure : ambulatory laparoscopic hysterectomy
- effective contraception if women of childbearing age
- patients with free, informed and signed consent
Who cannot join
- disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.
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.
Read more
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.
- Conditions
- Ambulatory Laparoscopic Hysterectomy
- Being tested
- Low Impact Laparoscopy, conventional laparoscopy, Visual Analog Scale (VAS) for Pain, Saint-Antoine Pain Questionnaire (QDSA), post-operative questionnaire
- Keywords
- Low Impact Laparoscopy, laparoscopy, hysterectomy, ambulatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Impact LaparoscopyDevice
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 laparoscopyDevice
conventional laparoscopy
Visual Analog Scale (VAS) for PainOther
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)Other
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 questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Impact Laparoscopy | Experimental | 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). Receives: Device: Low Impact Laparoscopy; Other: Visual Analog Scale (VAS) for Pain; Other: Saint-Antoine Pain Questionnaire (QDSA); Other: post-operative questionnaire |
| conventional laparoscopy | Active comparator | conventional laparoscopy Receives: Device: conventional laparoscopy; Other: Visual Analog Scale (VAS) for Pain; Other: Saint-Antoine Pain Questionnaire (QDSA); Other: post-operative questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of ambulatory care
rate of patients actually managed on an outpatient setting (discharged from hospital the same day of the intervention) and who presented no complication or rehospitalization in the month following the intervention
Measured: 1 month after surgery
Secondary outcomes (27)
pain score (Visual analogic scale (VAS) for pain)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: arrival in the post-interventional surveillance room
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: 30 minutes after exit of operating room
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: 2 hours after exit of operating room
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: 4 hours after exit of operating room
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: 6 hours after exit of operating room
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: on leaving the hospital, an average of 8 hours after surgery
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: the day after surgery
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: 1 month after surgery
pain score (Saint-Antoine Pain Questionnaire (QDSA questionnaire))
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64.
Measured: 6 hours after exit of operating room
pain score (Saint-Antoine Pain Questionnaire (QDSA))
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64
Measured: the day after surgery
dose of morphine
total dose of morphine (miligramme (mg)) administered in the post-interventional surveillance room
Measured: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
number of patients who needed an analgesic
number of patients who needed an analgesic supplement in post-interventional monitoring room
Measured: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
number of patients who needed an analgesic
number of patients who needed an analgesic supplement in post-interventional monitoring room
Measured: on leaving the hospital, an average of 8 hours after surgery
number of patients who needed an analgesic
number of patients who needed an analgesic supplement in post-interventional monitoring room
Measured: 1 month after surgery
total administered dose
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
Measured: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
total administered dose
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
Measured: on leaving the hospital, an average of 8 hours after surgery
total administered dose
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
Measured: 1 month after surgery
duration of analgesic treatment
duration of analgesic treatment (days) during the hospital stay
Measured: on leaving the hospital
duration of analgesic treatment
duration of analgesic treatment (days) during the hospital stay
Measured: 1 month after surgery
operating time
operative time (between incision and closure) in minutes
Measured: at the exit of the operating room, an average of 30 minutes after surgery
number of per and postoperative complications
number of per and postoperative complications
Measured: 1 month after surgery
types of per and postoperative complications
description of per and postoperative complications
Measured: 1 month after surgery
hours total of stay in the post-intervention monitoring room
length of stay in the post-interventional surveillance room in hours
Measured: at the exit of a post-interventional surveillance room
number of days of hospital stay
length of hospital stay (if non ambulatory care) in number of days
Measured: on leaving the hospital
number of days of work stoppage
duration of work stoppage of the patient in number of days
Measured: 1 month after surgery
patient management costs
Patient management costs according to the two surgical strategies
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start3 Jun 2020
- Primary completion3 Jan 2023
- Study completion3 Sep 2023
Why it stopped: There is no more material
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165148
- Sponsor's protocol ID
- 69HCL19_0335
- Other IDs
- 2019-A01863-54
- Acronym
- RANDOLIL
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2019
- Last updated
- 18 Apr 2024
- 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 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care
- ClinicalTrials.gov ID
- NCT04165148
- Acronym / sponsor ID
- RANDOLIL / 69HCL19_0335
- Conditions
- Ambulatory Laparoscopic Hysterectomy
- Keywords
- Low Impact Laparoscopy, laparoscopy, hysterectomy, ambulatory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is no more material
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 15 Nov 2019 (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.
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Impact Laparoscopy | Experimental | Device: Low Impact Laparoscopy, Other: Visual Analog Scale (VAS) for Pain, Other: Saint-Antoine Pain Questionnaire (QDSA), Other: post-operative questionnaireLow 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). |
| conventional laparoscopy | Active comparator | Device: conventional laparoscopy, Other: Visual Analog Scale (VAS) for Pain, Other: Saint-Antoine Pain Questionnaire (QDSA), Other: post-operative questionnaireconventional laparoscopy |
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)
- women over 18 years
- planned surgery procedure : ambulatory laparoscopic hysterectomy
- effective contraception if women of childbearing age
- patients with free, informed and signed consent
Key exclusion criteria (8 listed)
- disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- pregnancy or wish for subsequent pregnancy
- lactating women
- contraindication to laparoscopy
- contraindication to minimally invasive endoscopic techniques
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 |
|---|---|---|
| Low Impact LaparoscopyLow 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). | Device | Low Impact Laparoscopy |
| conventional laparoscopyconventional laparoscopy | Device | conventional laparoscopy |
| Visual Analog Scale (VAS) for PainThe 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. | Other | Low Impact Laparoscopy, conventional laparoscopy |
| 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. | Other | Low Impact Laparoscopy, conventional laparoscopy |
| post-operative questionnaireThe 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. | Other | Low Impact Laparoscopy, conventional laparoscopy |
Primary outcome
success rate of ambulatory care
Time frame: 1 month after surgery
rate of patients actually managed on an outpatient setting (discharged from hospital the same day of the intervention) and who presented no complication or rehospitalization in the month following the intervention
27 secondary outcomes
pain score (Visual analogic scale (VAS) for pain)
Time frame: arrival in the post-interventional surveillance room
pain score (VAS)
Time frame: 30 minutes after exit of operating room
pain score (VAS)
Time frame: 2 hours after exit of operating room
pain score (VAS)
Time frame: 4 hours after exit of operating room
pain score (VAS)
Time frame: 6 hours after exit of operating room
pain score (VAS)
Time frame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
pain score (VAS)
Time frame: on leaving the hospital, an average of 8 hours after surgery
pain score (VAS)
Time frame: the day after surgery
pain score (VAS)
Time frame: 1 month after surgery
pain score (Saint-Antoine Pain Questionnaire (QDSA questionnaire))
Time frame: 6 hours after exit of operating room
pain score (Saint-Antoine Pain Questionnaire (QDSA))
Time frame: the day after surgery
dose of morphine
Time frame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
number of patients who needed an analgesic
Time frame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
number of patients who needed an analgesic
Time frame: on leaving the hospital, an average of 8 hours after surgery
number of patients who needed an analgesic
Time frame: 1 month after surgery
total administered dose
Time frame: at the exit of a post-interventional surveillance room, an average of 2 hours after arrival
total administered dose
Time frame: on leaving the hospital, an average of 8 hours after surgery
total administered dose
Time frame: 1 month after surgery
duration of analgesic treatment
Time frame: on leaving the hospital
duration of analgesic treatment
Time frame: 1 month after surgery
operating time
Time frame: at the exit of the operating room, an average of 30 minutes after surgery
number of per and postoperative complications
Time frame: 1 month after surgery
types of per and postoperative complications
Time frame: 1 month after surgery
hours total of stay in the post-intervention monitoring room
Time frame: at the exit of a post-interventional surveillance room
number of days of hospital stay
Time frame: on leaving the hospital
number of days of work stoppage
Time frame: 1 month after surgery
patient management costs
Time frame: 1 month after surgery
Results and safety
The study was stopped early (reason given: There is no more material). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Impact Laparoscopy, conventional laparoscopy and Visual Analog Scale (VAS) for Pain in people with Ambulatory Laparoscopic Hysterectomy, run by Hospices Civils de Lyon 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 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: stopped early, as of the sponsor's last update on 18 Apr 2024. 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 was stopped early (reason given: There is no more material). Results are not available in the source record.
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?
success rate of ambulatory care (time frame: 1 month 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 Apr 2024.