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NCT Number: NCT05421156

Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy

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.

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Key information

Conditions

Hysterectomy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Women with gynecological and non-gynecological cancers.

Treatment and study plan

Subtotal Laparoscopic Hysterectomy

Procedure

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

Total laparoscopic hysterectomy

Procedure

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

Primary outcomes

  1. Sexual Dysfunctions

    Time frame: 5 years after surgery

    Female Sexual Function Index

Secondary outcomes

  1. Urinary Dysfunctions

    Time frame: 5 years after surgery

    Pelvic Floor Distress Inventory short form

  2. Pelvic Organ Prolapse

    Time frame: 5 years after surgery

    Pelvic Organ Prolapse (POP-Q) evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Simone Laganà, M.D., Ph.D.

CONTACT

[email protected]

3296279579

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions

Acronym: LAST-1

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 16, 2022
Registry last updated
Nov 2, 2022

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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