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

NCT02703246 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-05

No results posted yet for this study

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

Interventions

PROCEDURE

abdominal morcellation

patients will be randomized to receive abdominal morcellation

PROCEDURE

vaginal morcellation

patients will be randomized to receive vaginal morcellation

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Gaby Moawad, MD · George Washington University Medical Faculty Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703246 on ClinicalTrials.gov