RANDOLIL: Low Impact Laparoscopy Concept Versus Conventional Laparoscopy
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Device: 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).
Other: 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.
Other: 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: 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.
|
| Active Comparator: conventional laparoscopy conventional laparoscopy |
Device: conventional laparoscopy
conventional laparoscopy
Other: 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.
Other: 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: 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.
|
Outcome Measures
Primary Outcome Measures
- success rate of ambulatory care [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
Secondary Outcome Measures
- pain score (Visual analogic scale (VAS) for pain) [arrival in the post-interventional surveillance room]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [30 minutes after exit of operating room]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [2 hours after exit of operating room]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [4 hours after exit of operating room]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [6 hours after exit of operating room]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [at the exit of a post-interventional surveillance room, an average of 2 hours after arrival]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [on leaving the hospital, an average of 8 hours after surgery]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [the day after surgery]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (VAS) [1 month after surgery]
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
- pain score (Saint-Antoine Pain Questionnaire (QDSA questionnaire)) [6 hours after exit of operating room]
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64.
- pain score (Saint-Antoine Pain Questionnaire (QDSA)) [the day after surgery]
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64
- dose of morphine [at the exit of a post-interventional surveillance room, an average of 2 hours after arrival]
total dose of morphine (miligramme (mg)) administered in the post-interventional surveillance room
- number of patients who needed an analgesic [at the exit of a post-interventional surveillance room, an average of 2 hours after arrival]
number of patients who needed an analgesic supplement in post-interventional monitoring room
- number of patients who needed an analgesic [on leaving the hospital, an average of 8 hours after surgery]
number of patients who needed an analgesic supplement in post-interventional monitoring room
- number of patients who needed an analgesic [1 month after surgery]
number of patients who needed an analgesic supplement in post-interventional monitoring room
- total administered dose [at the exit of a post-interventional surveillance room, an average of 2 hours after arrival]
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
- total administered dose [on leaving the hospital, an average of 8 hours after surgery]
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
- total administered dose [1 month after surgery]
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
- duration of analgesic treatment [on leaving the hospital]
duration of analgesic treatment (days) during the hospital stay
- duration of analgesic treatment [1 month after surgery]
duration of analgesic treatment (days) during the hospital stay
- operating time [at the exit of the operating room, an average of 30 minutes after surgery]
operative time (between incision and closure) in minutes
- number of per and postoperative complications [1 month after surgery]
number of per and postoperative complications
- types of per and postoperative complications [1 month after surgery]
description of per and postoperative complications
- hours total of stay in the post-intervention monitoring room [at the exit of a post-interventional surveillance room]
length of stay in the post-interventional surveillance room in hours
- number of days of hospital stay [on leaving the hospital]
length of hospital stay (if non ambulatory care) in number of days
- number of days of work stoppage [1 month after surgery]
duration of work stoppage of the patient in number of days
- patient management costs [1 month after surgery]
Patient management costs according to the two surgical strategies
Eligibility Criteria
Criteria
Inclusion Criteria:
-
women over 18 years
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planned surgery procedure : ambulatory laparoscopic hysterectomy
-
effective contraception if women of childbearing age
-
patients with free, informed and signed consent
Exclusion Criteria:
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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 ....)
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pregnancy or wish for subsequent pregnancy
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lactating women
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contraindication to laparoscopy
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contraindication to minimally invasive endoscopic techniques
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not eligible for outpatient care
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inability to understand the information given
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a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Femme Mère Enfant | Bron | France | 69677 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL19_0335
- 2019-A01863-54