Trial Outcomes & Findings for Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy (NCT NCT04797585)

NCT ID: NCT04797585

Last Updated: 2024-09-19

Results Overview

Completion = time of abdominal incisions closed

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

One day intraoperative

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Laparoscopic Supracervical Hysterectomy Minimally invasive procedure to remove a woman's uterus Laparoscopic supracervical hysterectomy: Laparoscopic supracervical hysterectomy	Vaginal Hysterectomy Surgical procedure to remove the uterus Vaginal hysterectomy: Vaginal hysterectomy
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Supracervical Hysterectomy n=1 Participants Minimally invasive procedure to remove a woman's uterus Laparoscopic supracervical hysterectomy: Laparoscopic supracervical hysterectomy	Vaginal Hysterectomy n=2 Participants Surgical procedure to remove the uterus Vaginal hysterectomy: Vaginal hysterectomy	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	NA Years n=5 Participants	70.5 Years n=7 Participants	69.7 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: One day intraoperative

Completion = time of abdominal incisions closed

Outcome measures

Outcome measures
Measure	Laparoscopic Supracervical Hysterectomy n=1 Participants Minimally invasive procedure to remove a woman's uterus Laparoscopic supracervical hysterectomy: Laparoscopic supracervical hysterectomy	Vaginal Hysterectomy n=2 Participants Surgical procedure to remove the uterus Vaginal hysterectomy: Vaginal hysterectomy
Total Surgical Time - Time of Incision to Time of Sacrocolpopexy Completion	NA Minutes Interval 253.0 to 253.0 Measure of central tendency is n/a as there is only one participant.	387.5 Minutes Interval 379.0 to 396.0

SECONDARY outcome

Timeframe: 24 months

Mean difference between baseline (pre-operative) and 24 months post-procedure. The Pelvic Floor Disability Index (PFDI-20) is a is a short form that gives a comprehensive assessment of the effect of pelvic floor disorders. The scale exists from 0-4 (0=not present, 4=quite a bit)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Mean difference between baseline (pre-operative) and 24 months post-procedure. The Incontinence Severity Index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe. The scale exists from 0-12 (0=none, 12=very severe).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Mean difference between baseline (pre-operative) and 24 months post-procedure. The Patient Global Improvement Indices (PGII) is a seven-item measure which measures symptoms and degree of bother. The scale exists from 0-7 (0=very much better, 7=very much worse).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Mean difference between baseline (pre-operative) and 24 months post-procedure. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. The scale exists from 0-4 (0=never, 4=always).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Subjective recurrence is defined as patients who complain of vaginal bulge sumptoms (Question #3 on the PFDI-20)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Mesh erosion is defined as presence of eroded mesh in the vagina on examination postoperatively up to 24 months after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Objective recurrence is defined by POP-Q: Apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen

Outcome measures

Outcome data not reported

Adverse Events

Laparoscopic Supracervical Hysterectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaginal Hysterectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cecile Ferrando, M.D.

Cleveland Clinic Foundation

Phone: 216-444-0642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place