Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy

Hysterectomy Clinical Trial

— LAST-1  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05421156
• Other study ID #: LAST-1
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2028

Study information

• Verified date: October 2022
• Source: University of Palermo
• Contact: Antonio Simone Laganà, M.D., Ph.D.
• Phone: 3296279579
• Email: antoniosimone.lagana[@]unipa.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2028
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women with gynecological and non-gynecological cancers.

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Subtotal Laparoscopic Hysterectomy
Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.
• Total Laparoscopic Hysterectomy
Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Dysfunctions	Female Sexual Function Index	5 years after surgery
Secondary	Urinary Dysfunctions	Pelvic Floor Distress Inventory short form	5 years after surgery
Secondary	Pelvic Organ Prolapse	Pelvic Organ Prolapse (POP-Q) evaluation	5 years after surgery