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Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery

NCT05102032 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-11-01

No results posted yet for this study

Summary

Background Managing perioperative stress, including endocrino-metabolic changes and, inflammatory and pain responses, is a major challenge to improve patient's recovery. Currently, minimally invasive surgical procedures combined with multimodal analgesia are commonly used to increase the quality of postoperative period.

Purpose To demonstrate that a minimally invasive approach including low insufflation pressure and minitrocars in laparoscopic hysterectomy improves postoperative recovery and reduces pain stimulation and opioid consumption in comparison with a conventional approach.

Methods After informed consent, all patients scheduled for a laparoscopic hysterectomy including those with carcinologic disease will be part of this monocentric prospective randomized double-blinded study.

At admission in our outpatient unit, patients will have to fill the Post-operative Quality of Recovery Scale assessment form, before to be randomized into one of the following two groups:

* Conventional approach: laparoscopic procedure including standard trocars (3 trocars of 5 mm and a 10 mm-optic trocar) with insufflation pressures between 10 and 12 mmHg.
* Mini-invasive approach : laparoscopic surgery using mini-trocars (3 trocars of 3 mm and a 5 mm-optic trocar) with insufflation pressures of less than 8 mmHg.

Both groups will have general anesthesia with a deep neuromuscular blockade (TOF = 0 at the thumb adductor) and will benefit of our enhanced recovery program. Patients and evaluators will be blind regarding the allocated group.

The primary outcome is a comparison of the postoperative recovery between the two groups through the Post-operative Quality of Recovery Scale.This evaluation will include pain data, nausea/vomiting evaluation and cognitive function 6 hours after surgery.

Secondary outcomes are morphine consumption surgical comfort and patient satisfaction.

Conditions

  • Uterus Disease

Interventions

PROCEDURE

mini invasive approach

using mini-trocars (3 trocars of 3 mm and a 5 mm-optic trocar) with insufflation pressures of less than 8 mmHg.

PROCEDURE

Conventional approach

laparoscopic procedure including standard trocars (3 trocars of 5 mm and a 10 mm-optic trocar) with insufflation pressures between 10 and 12 mmHg.

Sponsors & Collaborators

  • Institut Mutualiste Montsouris

    lead OTHER

Principal Investigators

  • Karim BOUATTOUR, Doctor · Institut Mutualiste Montsouris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102032 on ClinicalTrials.gov