Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes

NCT02703246 | Withdrawn

• 1 other identifier: 091553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will perform a randomized trial to compare the surgical outcomes of vaginal versus abdominal morcellation of the uterus during hysterectomy. In minimally invasive gynecologic surgery small incisions are made in the abdomen and pelvis so that a hysterectomy can be performed by laparoscopy. The challenge is then to remove the uterus, which may be quite large, through these small incisions. One option is to morcellate the uterus and remove the tissue through either a small abdominal incision or an incision in the vagina. When an organ is morcellated it is cut into smaller pieces so that it can be removed, section by section, through a small incision. The investigators will compare these two methods of tissue removal to see whether one results in better surgical outcomes or increased intra-operative or post-operative complications. The primary outcome will be the time it takes to perform the surgery (operative time). Secondary surgical outcomes that will be studied include the amount of blood lost during surgery, post-operative complications, and readmission to the hospital.

Conditions

Fibroids

Keywords

Hysterectomy, Vaginal; Hysterectomy, Abdominal

Outcome Measures

Primary Outcomes (1)

• Total operative time

  Time (in minutes) from when first cut is made until last suture is made.

  Perioperative

Secondary Outcomes (3)

• Blood Loss

  perioperative

• Intraoperative complications

  perioperative

• Post-operative complications

  as recorded between end of operation and 4 weeks post operation

Study Arms (2)

abdominal morcellation

ACTIVE COMPARATOR

Women randomized to this group will undergo abdominal morcellation.

Procedure: abdominal morcellation

vaginal morcellation

ACTIVE COMPARATOR

Women randomized to this group will undergo vaginal morcellation.

Procedure: vaginal morcellation

Interventions

abdominal morcellation PROCEDURE

patients will be randomized to receive abdominal morcellation

abdominal morcellation

vaginal morcellation PROCEDURE

patients will be randomized to receive vaginal morcellation

vaginal morcellation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hysterectomy planned for a benign gynecologic reason
• Patient is scheduled to have surgery with one of the minimally invasive gynecologic surgeons at George Washington University Hospital. (Dr. Moawad, Dr. Marfori, or Dr. Vargas)
• Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH)
• Patient is capable of informed consent
• Patient must be between 18 and 65 years of age
• Uterus greater than 12 centimeters in height and 4 centimeters in width or 12 weeks in size

You may not qualify if:

• Hysterectomy is indicated for malignancy
• Procedure is anything other than RA-TLH or TLH
• Surgeon is not one of hte minimally invasive surgeons at GWUH
• Surgery is scheduled for a hospital other than GWUH
• Patient does not meet the age requirements.
• Patient is not capable of informed consent
• Uterus is less than 12 cm in heightand 4 cm in width

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Gaby Moawad, MD

  George Washington University Medical Faculty Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)