Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy

NCT ID: NCT05421156

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2028-07-31

Brief Summary

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Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.

Detailed Description

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Conditions

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Hysterectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subtotal Laparoscopic Hysterectomy

Women who underwent subtotal laparoscopic hysterectomy

Subtotal Laparoscopic Hysterectomy

Intervention Type PROCEDURE

Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.

Total Laparoscopic Hysterectomy

Women who underwent total laparoscopic hysterectomy

Total Laparoscopic Hysterectomy

Intervention Type PROCEDURE

Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy

Interventions

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Subtotal Laparoscopic Hysterectomy

Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.

Intervention Type PROCEDURE

Total Laparoscopic Hysterectomy

Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.

Exclusion Criteria

* Women with gynecological and non-gynecological cancers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Antonio Simone Laganà

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Simone Laganà, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Central Contacts

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Antonio Simone Laganà, M.D., Ph.D.

Role: CONTACT

3296279579

Other Identifiers

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LAST-1

Identifier Type: -

Identifier Source: org_study_id

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