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

NCT ID: NCT05337046

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-09-27

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).

Conditions

Endometrial Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tissue removal system

Endometrial polyp removed by hysteroscopic tissue removal system in a previous study.

No interventions assigned to this group

Bipolar resectoscopy

Endometrial polyp removed by hysteroscopic bipolar resectoscopy in a previous study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• participation in earlier study

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tjalina Hamerlynck, Md, Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Catharina ziekenhuis

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

References

Hamerlynck TW, Blikkendaal MD, Schoot BC, Hanstede MM, Jansen FW. An alternative approach for removal of placental remnants: hysteroscopic morcellation. J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):796-802. doi: 10.1016/j.jmig.2013.04.024.

Reference Type: RESULT

PMID: 24183271 (View on PubMed)

Other Identifiers

BC-11629 BC-11630 BC-11631

Identifier Type: -

Identifier Source: org_study_id