Trials Sponsors Conditions Drugs Pricing

Conditions

Hysterectomy

Keywords

HysterectomyPelvic washingsMyometrial cell spillageFibroids

Outcome Measures

Primary Outcomes (1)

Detection of myometrial cell spillage in peritoneal washing
To evaluate potential cell spillage from morcellated tissue, the 3 peritoneal washings collected will be sent to cytology lab to be examined for the presence of smooth muscle cells
Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.

Secondary Outcomes (1)

Timing of myometrial cell spillage during hysterectomy
Pelvic washing samples will be sent the pathology lab to be examined within 2 days of the surgery.

Study Arms (1)

Pelvic washings

Three Samples of peritoneal washings will be collected and send to pathology. looking for myometrial cell spillage at three designated points in surgery. 1st before hysterectomy, 2nd after hysterectomy, and 3rd after morcellation and extraction of the uterus out of the abdominal cavity.

Diagnostic Test: Peritoneal washings

Interventions

Peritoneal washingsDiagnostic test

Peritoneal washing will be done at designated point in the surgical procedure. one hundred cc of normal saline, will be used to irrigate the peritoneal cavity. Samples of the fluid will be collected, with the goal to collect as much fluid as possible for the study, with minimum of 60 cc should be collected. Samples will be sent to the pathology lab. 1. First washing will be collected after obtaining entry into the peritoneal cavity with placement of the first laparoscopic trocar, before any manipulation of the uterus. 2. Second washing will be done after the hysterectomy and containment of the uterus in the bag. 3. Third washing will be collected after scalpel morcellation of the uterus in the containment bag, extraction and closure of the vaginal cuff.

Pelvic washings

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Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Women needing minimally invasive hysterectomy for benign conditions, 18 years and older.

You may qualify if:

Women undergoing minimally invasive Laparoscopic / Robotic hysterectomy for presumably benign conditions such as (fibroids, adenomyosis, endometriosis, pelvic organ prolapse, abnormal uterine bleeding)

Sponsors & Collaborators

The University of Texas Medical Branch, Galveston
Otherlead

Study Sites (1)

University of Texas Medical branch

Galveston, Texas, 77555, United States

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

August 1, 2023

Actual (reported)

Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Pelvic washings

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Pelvic washings

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations