Low Impact Laparoscopy Concept Versus Conventional Laparoscopy

NCT04165148 | Terminated

• 2 other identifiers: 69HCL19_03352019-A01863-54
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Ambulatory Laparoscopic Hysterectomy

Keywords

Low Impact Laparoscopy; laparoscopy; hysterectomy; ambulatory

Outcome Measures

Primary Outcomes (1)

• 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

  1 month after surgery

Secondary Outcomes (27)

• pain score (Visual analogic scale (VAS) for pain)

  arrival in the post-interventional surveillance room

• pain score (VAS)

  30 minutes after exit of operating room

• pain score (VAS)

  2 hours after exit of operating room

• pain score (VAS)

  4 hours after exit of operating room

• pain score (VAS)

  6 hours after exit of operating room

Study Arms (2)

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).

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

Device: conventional laparoscopy; Other: Visual Analog Scale (VAS) for Pain; Other: Saint-Antoine Pain Questionnaire (QDSA); Other: post-operative questionnaire

Interventions

Low Impact Laparoscopy DEVICE

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).

Low Impact Laparoscopy

conventional laparoscopy DEVICE

conventional laparoscopy

conventional laparoscopy

Visual Analog Scale (VAS) for Pain OTHER

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.

Low Impact Laparoscopy; conventional laparoscopy

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.

Low Impact Laparoscopy; conventional laparoscopy

post-operative questionnaire OTHER

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.

Low Impact Laparoscopy; conventional laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 15, 2019
• Study Start: June 3, 2020
• Primary Completion: January 3, 2023
• Study Completion: September 3, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

FR (1)