NCT02367703

Brief Summary

Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

February 6, 2015

Last Update Submit

September 18, 2015

Conditions

Benign Uterine Diseases

Keywords

Mini-laparoscopyhysterectomyBenign uterine diseasesOperative time

Outcome Measures

Primary Outcomes (1)

  • operative time

    at day 1 (at the end of the surgery)

Secondary Outcomes (8)

  • quantity of intraoperative bleeding

    at day 1 (at the end of the intervention)

  • hemoglobin

    at day 1

  • Pain Rating Scale (VAS)

    at day 1 (at 6 hours potoperative hours)

  • Pain Rating Scale (VAS)

    at day 1 (at 24 postoperative hours)

  • standard laparoscopy conversion rate

    at day 1

  • +3 more secondary outcomes

Study Arms (2)

standard instrument

EXPERIMENTAL

That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy

Procedure: laparoscopic hysterectomy

less than 3 millimeter diameter's instruments

OTHER

That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy

Procedure: laparoscopic hysterectomy

Interventions

laparoscopic hysterectomyPROCEDURE
less than 3 millimeter diameter's instrumentsstandard instrument

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
  • benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.
  • and
  • affiliation to social security and
  • informed consent

You may not qualify if:

  • ASA III or IV patients,
  • age\> 80 years old,
  • history of major abdominal surgery by laparotomy
  • severe obesity (BMI\> 35kg / m2)
  • pathology of hemostasis and coagulation (liver disease, bleeding disorders)
  • uterine volume estimated on preoperative ultrasonography \> 300 g
  • minor patients,
  • adult lacking legal capacity
  • patients suffering from mental illness incompatible with informed consent, refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Officials

  • Revaz BOTCHORISHVILI

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 20, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

FR(1)