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

NCT05102032 | Unknown

• 1 other identifier: ANEST-01-2019
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

post operative recovery; laparoscopic hysterectomy; mini invasive surgery; low pressure laparoscopy

Outcome Measures

Primary Outcomes (1)

• immediate postoperative recovery

  determined by the Post Operative Quality of recovery scale PQRS (pain score, PONV and cognitive recovery)

  6th post-operative hour

Secondary Outcomes (11)

• intraoperative intensity of nociceptive stimulation

  4th induction hour

• postoperative pain intensity: Verbal Numeric Scale (VNS)

  2nd, 6th and 24th post-operatives hours

• Patient satisfaction: EVAN G score

  24th post-operative hour

• rate of return after discharge

  Day 7 after discharge

• Bowel movement

  Day 1 after discharge

Study Arms (2)

Conventional approach

ACTIVE COMPARATOR

Conventional approach to laparoscopic hysterectomy

Procedure: Conventional approach

Mini-invasive approach

EXPERIMENTAL

Mini-invasive approach to laparoscopic hysterectomy

Procedure: mini invasive approach

Interventions

mini invasive approach PROCEDURE

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

Mini-invasive approach

Conventional approach PROCEDURE

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

Conventional approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• programmed to laparoscopic hysterectomy
• stable ASA score \<3
• no contraindication to take nonsteroidal anti-inflammatory drugs
• absence of chronic pain
• perfect understanding of post-operative psycho-motor assessment
• presence of an attendant
• distance between home and hospital allowing a possible quick readmission
• acceptance to respect all the given medical instructions.

You may not qualify if:

• laparo-conversion and surgical or anesthetic complication.

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Insitut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Karim BOUATTOUR, Doctor

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Responsable of Clinical Research Unit

CONTACT

+ 33 156616705; isabelle.sauret@imm.fr

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: October 3, 2019
• First Posted: November 1, 2021
• Study Start: December 2, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

FR (1)