FibroidsNCT02703246
Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes
A study testing abdominal morcellation and vaginal morcellation in people with Fibroids, run by George Washington University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibroids
- What is being tested?
- abdominal morcellation and vaginal morcellation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
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.
Read the detailed description
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.
- Conditions
- Fibroids
- Being tested
- abdominal morcellation, vaginal morcellation
- Keywords
- Hysterectomy, Vaginal, Hysterectomy, Abdominal
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal morcellationProcedure or surgery
patients will be randomized to receive abdominal morcellation
vaginal morcellationProcedure or surgery
patients will be randomized to receive vaginal morcellation
| Study group | Role | What they receive |
|---|---|---|
| abdominal morcellation | Active comparator | Women randomized to this group will undergo abdominal morcellation. Receives: Procedure: abdominal morcellation |
| vaginal morcellation | Active comparator | Women randomized to this group will undergo vaginal morcellation. Receives: Procedure: vaginal morcellation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operative time
Time (in minutes) from when first cut is made until last suture is made.
Measured: Perioperative
Secondary outcomes (3)
Blood Loss
as measured in cubic centimeters (cc)
Measured: perioperative
Intraoperative complications
Intraoperative complications include: Organ injury (bladder, bowel, vaginal laceration), Estimated Blood Loss>1000cc, and conversion to laparotomy
Measured: perioperative
Post-operative complications
Post-operative complications include: Reoperation, Intensive Care Unit (ICU) admission, Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE), transfusion, Readmission, Bowel obstruction/ileus, Incision seroma/cellulitis/hematoma/separation/hernia, and cuff cellulitis/abcess/dehiscence/granulation tissue
Measured: as recorded between end of operation and 4 weeks post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: investigator left the institution- no plan on having another PI take over
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidsStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaby Moawad, MD, Principal investigator, George Washington University Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703246
- Sponsor's protocol ID
- 091553
- Status last verified
- Jun 2023
- First submitted
- 8 Feb 2016
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes
- ClinicalTrials.gov ID
- NCT02703246
- Acronym / sponsor ID
- 091553
- Conditions
- Fibroids
- Keywords
- Hysterectomy, Vaginal, Hysterectomy, Abdominal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigator left the institution- no plan on having another PI take over
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abdominal morcellation | Active comparator | Procedure: abdominal morcellationWomen randomized to this group will undergo abdominal morcellation. |
| vaginal morcellation | Active comparator | Procedure: vaginal morcellationWomen randomized to this group will undergo vaginal morcellation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal morcellationpatients will be randomized to receive abdominal morcellation | Procedure or surgery | abdominal morcellation |
| vaginal morcellationpatients will be randomized to receive vaginal morcellation | Procedure or surgery | vaginal morcellation |
Primary outcome
Total operative time
Time frame: Perioperative
Time (in minutes) from when first cut is made until last suture is made.
3 secondary outcomes
Blood Loss
Time frame: perioperative
Intraoperative complications
Time frame: perioperative
Post-operative complications
Time frame: as recorded between end of operation and 4 weeks post operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaby Moawad, MD principal investigator
George Washington University Medical Faculty Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal morcellation and vaginal morcellation in people with Fibroids, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operative time (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.