5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy

NCT06526962 | Recruiting

• 1 other identifier: HYSTOP
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting.

Conditions

Endometrial Polyp

Keywords

Hysteroscopy; Outpatient; Endometrial Polyp; Polypectomy; Dual Wave-Lenght Diode Laser

Outcome Measures

Primary Outcomes (1)

• Time required to perform the operative hysteroscopic procedure.

  The time required to perform the operative hysteroscopic procedure, which will be measured in seconds from the entry into the uterine cavity until the completion of the procedure, defined as the complete resection of the lesion (excluding the time related to the extraction of the resected material).

  End of procedure

Secondary Outcomes (8)

• Need for supplementary instrumentation

  End of procedure

• Effectiveness in removing the lesions

  60 days

• Adverse events

  30 minutes

• Quantity of resected tissue

  40 days

• Instrument Suitability

  End of procedure

Study Arms (2)

Group A

Patients who undergo outpatient hysteroscopic polypectomy using 5Fr bipolar electrode

Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser

Group B

Patients who undergo outpatient hysteroscopic polypectomy using a conical optical 5Fr fibers for dual wave-length diode laser

Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser

Interventions

5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser DEVICE

Outpatient hysteroscopic polypectomy

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy

You may qualify if:

• age ≥18 years and \< 60 years;
• suspicion of a single endometrial polyp, documented by ultrasound, with dimensions less than 20 mm;
• presence of abnormal uterine bleeding or history of infertility (defined as absence of conception after 12 months of regular unprotected intercourse aimed at conception);
• consent to participate in the study.

You may not qualify if:

• presence of multiple endometrial polyps;
• presence of a single endometrial polyp with dimensions greater than 20 mm;
• concurrent presence of intrauterine fibroids, focal or diffuse endometrial thickening, and/or intrauterine adhesions (synechiae);
• current or recent use (\< 3 months) of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
• presence of another known cause of vaginal/cervical bleeding;
• suspected adnexal pathology;
• confirmed diagnosis of endometrial cancer;
• suspected acute pelvic inflammation or recent history of pelvic inflammation (\< 6 months);
• presence of tight cervical canal stenosis;
• requirement for any type of anesthesia to perform the hysteroscopic procedure.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Cagliari

Cagliari, 09042, Italy

RECRUITING

Related Publications (15)

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• Lasmar RB, Barrozo PR, Dias R, Oliveira MA. Submucous myomas: a new presurgical classification to evaluate the viability of hysteroscopic surgical treatment--preliminary report. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):308-11. doi: 10.1016/j.jmig.2005.05.014.

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• Lasmar RB, Xinmei Z, Indman PD, Celeste RK, Di Spiezio Sardo A. Feasibility of a new system of classification of submucous myomas: a multicenter study. Fertil Steril. 2011 May;95(6):2073-7. doi: 10.1016/j.fertnstert.2011.01.147. Epub 2011 Feb 21.

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  PMID: 22588767 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial Polyp

Central Study Contacts

Salvatore Giovanni Vitale, PhD

CONTACT

3479354575; salvatoreg.vitale@unica.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 30, 2024
• Study Start: May 7, 2024
• Primary Completion: November 7, 2024
• Study Completion: May 7, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

IT (1)