Low Impact Laparoscopy Concept Versus Conventional Laparoscopy

Not Applicable

Terminated

• Conditions: Ambulatory Laparoscopic Hysterectomy
• Interventions: Device: Low Impact Laparoscopy; Device: conventional laparoscopy; Other: Visual Analog Scale (VAS) for Pain; Other: Saint-Antoine Pain Questionnaire (QDSA); Other: post-operative questionnaire

• Registration Number: NCT04165148
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Study Start: 2020-06-03
• Primary Completion: 2023-01-03
• Study Completion: 2023-09-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• women over 18 years
• planned surgery procedure : ambulatory laparoscopic hysterectomy
• effective contraception if women of childbearing age
• patients with free, informed and signed consent

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional laparoscopy	post-operative questionnaire	conventional laparoscopy
Low Impact Laparoscopy	post-operative questionnaire	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	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	Visual Analog Scale (VAS) for Pain	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	Saint-Antoine Pain Questionnaire (QDSA)	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).
conventional laparoscopy	Visual Analog Scale (VAS) for Pain	conventional laparoscopy
conventional laparoscopy	Saint-Antoine Pain Questionnaire (QDSA)	conventional laparoscopy
conventional laparoscopy	conventional laparoscopy	conventional laparoscopy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
number of days of work stoppage	1 month after surgery	duration of work stoppage of the patient in number of days
pain score (VAS)	1 month after surgery	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
number of patients who needed an analgesic	1 month after surgery	number of patients who needed an analgesic supplement in post-interventional monitoring room
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
total administered dose	1 month after surgery	total administered dose of analgesic supplement (mg) in post-interventional monitoring room
duration of analgesic treatment	1 month after surgery	duration of analgesic treatment (days) during the hospital stay
types of per and postoperative complications	1 month after surgery	description of per and postoperative complications
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 (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.
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
number of days of hospital stay	on leaving the hospital	length of hospital stay (if non ambulatory care) in number of days
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
patient management costs	1 month after surgery	Patient management costs according to the two surgical strategies

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France