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Completed

NCT Number: NCT05337046

Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results

In this study, a comparison is made between two types of polyp resection methods (hysteroscopic tissue removal and bipolar resectoscopy). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps. The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.

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Key information

Conditions

Endometrial Polyp

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Catharina ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

  • Rationale: Several techniques for hysteroscopic removal of intrauterine polyps exist today. Up until the first decade of this century, larger polyps were usually removed via bipolar resectoscopy. Later, the hysteroscopic tissue removal system (morcellation) was introduced in which the abnormal tissue is mechanically removed, which is then immediately aspirated. Previous studies comparing bipolar resection and morcellation show that this is an effective, fast, and safe method without major complications. However, the long-term results are still largely unknown.
  • Research question/goal: To investigate the long-term results of the effectiveness of hysteroscopic removal of intrauterine polyps. Bipolar resection and morcellation are compared here.
  • Study design: This is a prospective cohort study. The patients previously participated in a randomized study (2011-2014) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.
  • Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in a previous study.
  • Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participation in earlier study

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire (yes/no, specify)

Secondary outcomes

  1. Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire (yes/no, specify)

  2. Recurrence interval (time to recurrence of endometrial polyp)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire (when did blood loss occur / when was polyp identified)

  3. Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire

  4. Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire (yes/no, specify)

  5. Rate of occurrence of new polyps (+ cause, treatment)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire (yes/no, specify)

  6. Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)

  7. General satisfaction score in regard to initial treatment

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)

  8. Rate of need for additional treatment

    Time frame: 8 to 10 years

    Patient reported outcome by means of a questionnaire (yes/no, specify)

  9. Chance of pregnancy after treatment

    Time frame: 8 to 10 years

    Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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