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Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy (RESMO)

Primary Purpose

Endometrial Polyps

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hysteroscopic morcellation
Standard hysteroscopic resection
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Polyps focused on measuring Endometrial polyp, Hysteroscopic resection, Morcellation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All major patients with single endometrial polyp,
  • Confirmed by a diagnostic hysteroscopy
  • Greater than or equal to one centimeter in size with no upper size limit
  • Patient giving informed consent
  • Subject belonging to a social security organisme

Exclusion Criteria:

  • Ongoing pregnancy or breastfeeding
  • Progressive malignant gynecological pathology
  • Evolutionary Genital infection
  • Suspected malignancy before surgery
  • Multiple Polyps
  • Polypoid hyperplasia
  • Associated submucosal myoma
  • Person under guardianship
  • Patient with contraindication to general anesthesia or spinal anesthesia
  • Person in an exclusion period (determined by a previous or ongoing study)
  • Inability to give the eprosn informed information (comprehension difficulties ...)

Sites / Locations

  • University Hospital, Strasbourg, france

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

morcellation

standard resection

Arm Description

Outcomes

Primary Outcome Measures

Morcellation or resection time (minutes)

Secondary Outcome Measures

The completeness of resection or not,
The total operating time (in minutes):
The amount of serum used (mL)
Perioperative complications,
The quality of vision defined by the operator on a scale of 0 to 5,
Persistence or not of the disease
evaluated by hysteroscopy
The occurrence of secondary adhesions

Full Information

First Posted
June 5, 2015
Last Updated
August 24, 2018
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02472197
Brief Title
Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy
Acronym
RESMO
Official Title
Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical procedure, the intrauterine pathology is resected by a transcervical approach in several fragments using a mono or bipolar cove after distension of the uterine cavity and by endoscopic control. The main risks of this surgery are: uterine perforation and OHIA (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are new intrauterine devices, recently appeared on the French market. In comparison to classical resectors, morcellators have several theoretical advantages: A smaller instrument diameter with potentially a lower risk of uterine perforation and cervical laceration during the dilatation procedure, The use of physiological serum, eliminating the risk of neurological toxicity of glycine, The risk of electrical accident is canceled (internal or external burns due to leakage current), A decreased risk of air embolism, due to the absence of bubbles' production, The instrument is always under visual control, the perforation risk by the active instrument is therefore very limited, The vision is not obscured by the fragments or by the bubbles, The treatment of pre-ostial pathologies, not always easy in classical resections, could be facilitated, the absence of thermal effect, and therefore a potentially lower endometrial aggression, is interesting in women with reproductive desire, Absence of chips management, limiting the entry and exit movements in the uterine cavity, improving the vision, reducing the infectious and traumatic risks, specially uterine perforation and air embolism, Morcellation could preserve tissues for histological analysis of possible malignancy (compared to techniques using heat, coagulation, vaporization), Easy learning in comparison to the time-consuming learning of classical hysteroscopic resection, Generated additional cost could be partly amortized by reducing operating time and complications. It seemed useful to study this new technology. The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated Bigatti Shaver IBS), Storz®, and a conventional resectoscope. The secondary purposes were to compare the efficiency, complications and comfort of these techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Polyps
Keywords
Endometrial polyp, Hysteroscopic resection, Morcellation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morcellation
Arm Type
Experimental
Arm Title
standard resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic morcellation
Intervention Description
The endometrial polyp is resected by a transcervical approach. During the procedure, the polyp is placed by suction against the window of the device, then cut by mechanical energy, in chips which are directly aspirated by the device.
Intervention Type
Procedure
Intervention Name(s)
Standard hysteroscopic resection
Intervention Description
The endometrial polyp is resected by a transcervical approach in several chips using a mono or bipolar cove after distension of the uterine cavity under endoscopic control.
Primary Outcome Measure Information:
Title
Morcellation or resection time (minutes)
Time Frame
From the cervical dilatation just before introducing the operative device until removal of the operative device assessed up to 25 minutes
Secondary Outcome Measure Information:
Title
The completeness of resection or not,
Time Frame
10 weeks after surgery
Title
The total operating time (in minutes):
Time Frame
from the beginning of diagnostic hysteroscopy to the end of operative hysteroscopy resection and removal of the operative device, assessed up to 25 minutes
Title
The amount of serum used (mL)
Time Frame
At the end of surgery
Title
Perioperative complications,
Time Frame
10 weeks after surgery
Title
The quality of vision defined by the operator on a scale of 0 to 5,
Time Frame
At the end of surgery
Title
Persistence or not of the disease
Description
evaluated by hysteroscopy
Time Frame
10 weeks after surgery
Title
The occurrence of secondary adhesions
Time Frame
10 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All major patients with single endometrial polyp, Confirmed by a diagnostic hysteroscopy Greater than or equal to one centimeter in size with no upper size limit Patient giving informed consent Subject belonging to a social security organisme Exclusion Criteria: Ongoing pregnancy or breastfeeding Progressive malignant gynecological pathology Evolutionary Genital infection Suspected malignancy before surgery Multiple Polyps Polypoid hyperplasia Associated submucosal myoma Person under guardianship Patient with contraindication to general anesthesia or spinal anesthesia Person in an exclusion period (determined by a previous or ongoing study) Inability to give the eprosn informed information (comprehension difficulties ...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GARBIN, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

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Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy

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