Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/18/2019 |
| Start Date: | January 2016 |
| End Date: | May 2019 |
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.
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.
Hysterectomy is the most commonly performed non-obstetric procedure in women in the United
States, with approximately 400,000 hysterectomies performed each year. Minimally invasive
techniques have all been shown to have advantages over laparotomy. These include decreased
blood loss, faster recovery time, improved postoperative pain and decreased postoperative
complications including wound infections, thromboembolism, iatrogenic injuries and incisional
hernias. Due to all of these benefits, the volume of minimally invasive procedures has
increased significantly over the last ten years making tissue extraction a widely debated
topic.
Morcellation is a technique that allows large pieces of tissue to be removed through small
incisions and was originally performed either with a scalpel or manual device until the first
power/electric morcellators were introduced in 1993. Since then, power morcellation has made
50,000 to 150,000 minimally invasive hysterectomies possible annually. While the former has
been an integral part in the treatment of women with large uteri and uterine fibroids, it has
recently come under scrutiny due to multiple concerns including dissemination of undetected
malignancy, development of iatrogenic myomas as well as increased number of reported
complications and death. This has led the US Food and drug administration in April 2014 to
issue a statement discouraging the use of laparoscopic power morcellation.
In the face of the growing bias against electronic mechanical morcellators, other approaches
must be investigated and promulgated so that patients may still benefit from minimally
invasive gynecologic surgeries. The two commonly used methods for tissue extraction are
manual morcellation through mini-laparotomy and vaginal morcellation. In the former, a trocar
site enlargement or a new up to 1 inch incision is created through which the specimen is
brought to the abdominal surface and morcellated with scalpel.In the latter, tissues are
removed in the same fashion but via a colpotomy. The investigators intent is to compare
manual morcellation methods (vaginal vs abdominal mini-laparotomy) in order to help surgeons
choose the best approach for their patient.
States, with approximately 400,000 hysterectomies performed each year. Minimally invasive
techniques have all been shown to have advantages over laparotomy. These include decreased
blood loss, faster recovery time, improved postoperative pain and decreased postoperative
complications including wound infections, thromboembolism, iatrogenic injuries and incisional
hernias. Due to all of these benefits, the volume of minimally invasive procedures has
increased significantly over the last ten years making tissue extraction a widely debated
topic.
Morcellation is a technique that allows large pieces of tissue to be removed through small
incisions and was originally performed either with a scalpel or manual device until the first
power/electric morcellators were introduced in 1993. Since then, power morcellation has made
50,000 to 150,000 minimally invasive hysterectomies possible annually. While the former has
been an integral part in the treatment of women with large uteri and uterine fibroids, it has
recently come under scrutiny due to multiple concerns including dissemination of undetected
malignancy, development of iatrogenic myomas as well as increased number of reported
complications and death. This has led the US Food and drug administration in April 2014 to
issue a statement discouraging the use of laparoscopic power morcellation.
In the face of the growing bias against electronic mechanical morcellators, other approaches
must be investigated and promulgated so that patients may still benefit from minimally
invasive gynecologic surgeries. The two commonly used methods for tissue extraction are
manual morcellation through mini-laparotomy and vaginal morcellation. In the former, a trocar
site enlargement or a new up to 1 inch incision is created through which the specimen is
brought to the abdominal surface and morcellated with scalpel.In the latter, tissues are
removed in the same fashion but via a colpotomy. The investigators intent is to compare
manual morcellation methods (vaginal vs abdominal mini-laparotomy) in order to help surgeons
choose the best approach for their patient.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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