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

Completed

• Conditions: Endometrial Polyp

• Registration Number: NCT05337046
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

* 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).

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Primary Completion: 2022-09-27
• Study Completion: 2022-09-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• participation in earlier study

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)	8 to 10 years	Patient reported outcome by means of a questionnaire (yes/no, specify)

Secondary Outcome Measures

Name	Time	Method
Recurrence interval (time to recurrence of endometrial polyp)	8 to 10 years	Patient reported outcome by means of a questionnaire (when did blood loss occur / when was polyp identified)
General satisfaction score in regard to initial treatment	8 to 10 years	Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)
Rate of need for additional treatment	8 to 10 years	Patient reported outcome by means of a questionnaire (yes/no, specify)
Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)	8 to 10 years	Patient reported outcome by means of a questionnaire (yes/no, specify)
Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)	8 to 10 years	Patient reported outcome by means of a questionnaire (yes/no, specify)
Chance of pregnancy after treatment	8 to 10 years	Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.
Rate of occurrence of new polyps (+ cause, treatment)	8 to 10 years	Patient reported outcome by means of a questionnaire (yes/no, specify)
Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)	8 to 10 years	Patient reported outcome by means of a questionnaire
Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)	8 to 10 years	Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)

Trial Locations

Locations (1)

Catharina ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands