Abnormal Uterine BleedingNCT04434066
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
A study testing Total Laparoscopic Hysterectomy in people with Abnormal Uterine Bleeding and Uterine Bleeding, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus
- What is being tested?
- Total Laparoscopic Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to 5 Nov 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
- Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
- Age >18 years old
- Uterus >12 weeks, or >250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
- English and Spanish speaking
Who cannot join
- Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
- Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
- Appendectomy for endometriosis is not excluded
- No chronic pain disorders requiring medical management (endometriosis can be included)
- Planned abdominal hysterectomy or vaginal hysterectomy candidates
- Conversion to laparotomy or inability to complete morcellation
- Contraindications to laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial
The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.
Read the detailed description
The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial.
Objectives:
- To evaluate differences in total operating time between subjects undergoing AM compared to VM.
- To evaluate differences in morcellation time between AM and VM.
- To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
- To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
- To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
- To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
- To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
- To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.
- Conditions
- Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus, Surgery
- Being tested
- Total Laparoscopic Hysterectomy
- Keywords
- hysterectomy, abnormal uterine bleeding, morcellation, abdominal, vaginal, surgery, laparoscopic, laparoscopy, total hysterectomy, pelvic pain, endometriosis
- Medical subject headings
- Metrorrhagia, Uterine Hemorrhage, Leiomyoma, Pelvic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Laparoscopic HysterectomyProcedure or surgery
Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Morcellation | Experimental | Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation. Receives: Procedure: Total Laparoscopic Hysterectomy |
| Vaginal Morcellation | Experimental | Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation. Receives: Procedure: Total Laparoscopic Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in total operating room time
Total operating room time is defined as skin incision to skin closure
Measured: intraoperative
Secondary outcomes (7)
Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
Body Image Scale will be collected at baseline, and 6-weeks post-operatively. Body Image Scale will be scored from 10 to 40 points maximum, with higher scores referring to being "very dissatisfied" with overall body image
Measured: through study completion up to 6-weeks post-operatively
Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively
Pain Visual Analogue Scale will be collected at baseline, and 6-weeks post-operatively. VAS scale will be measured from 0 to 10mm, with higher scores referring to more pain experienced
Measured: through study completion up to 6-weeks post-operatively
Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
Quality of Recovery will be collected at baseline, 24-hours, and 2-weeks post-operatively. Quality of Recovery will be scored from 10 to 100, with higher scores referring to better quality of recovery
Measured: through study completion up to 6-weeks post-operatively
Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
Quality of Life Scores will be collected at baseline, and 6-weeks post-operatively. The Quality of Life Score will be scored from 11 to 44, with higher scores referring to better quality of life
Measured: through study completion up to 6-weeks post-operatively
Morcellation Time
Defined as specimen bag introduction to specimen bag removal
Measured: intraoperative
Rates of Post-Operative Complications
Post-operative complications will be collected including: readmission to the hospital or emergency room, number of visits seen in the clinic, diagnoses of infection, bleeding, blood transfusions, surgery-related injuries, reoperations, and overall mortality
Measured: through study completion up to 6-weeks post-operatively
Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively
Measured: after surgery to 2-weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start8 Jan 2020
- Primary completion19 Jul 2022
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Kho, University of Texas Southwestern Medical Center
- Investigators
- Kimberly A Kho, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434066
- Sponsor's protocol ID
- STU-2019-1402
- Status last verified
- Nov 2024
- First submitted
- 12 Jun 2020
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
Siedhoff MT, Cohen SL. Tissue Extraction Techniques for Leiomyomas and Uteri During Minimally Invasive Surgery. Obstet Gynecol. 2017 Dec;130(6):1251-1260. doi: 10.1097/AOG.0000000000002334.
PubMed 29112659Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.
PubMed 25162248Solima E, Scagnelli G, Austoni V, Natale A, Bertulessi C, Busacca M, Vignali M. Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1244-6. doi: 10.1016/j.jmig.2015.07.007. Epub 2015 Jul 20.
PubMed 26205578Moawad GN, Abi KhalIL ED, Opoku-Anane J, Marfori CQ, Harman AC, Fisher S, Levy M, Robinson JK. Comparison of methods of morcellation: manual versus power. Acta Obstet Gynecol Scand. 2016 Jan;95(1):52-4. doi: 10.1111/aogs.12783. Epub 2015 Oct 19.
PubMed 26400045Meurs EAIM, Brito LG, Ajao MO, Goggins ER, Vitonis AF, Einarsson JI, Cohen SL. Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy. J Minim Invasive Gynecol. 2017 Jul-Aug;24(5):843-849. doi: 10.1016/j.jmig.2017.04.023. Epub 2017 May 5.
PubMed 28483536Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
PubMed 26801067Frasca C, Degli Esposti E, Arena A, Tuzzato G, Moro E, Martelli V, Seracchioli R. Can In-Bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial. Gynecol Obstet Invest. 2018;83(1):52-56. doi: 10.1159/000477171. Epub 2017 Jun 7.
PubMed 28586771Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.
PubMed 22704765Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019 May-Jun;26(4):702-708. doi: 10.1016/j.jmig.2018.07.020. Epub 2018 Aug 1.
PubMed 30075302
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT04434066
- Acronym / sponsor ID
- STU-2019-1402
- Conditions
- Abnormal Uterine Bleeding, Uterine Bleeding, Fibroid Uterus, Surgery
- Keywords
- hysterectomy, abnormal uterine bleeding, morcellation, abdominal, vaginal, surgery, laparoscopic, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.
Detailed description
The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial.
Objectives:
- To evaluate differences in total operating time between subjects undergoing AM compared to VM.
- To evaluate differences in morcellation time between AM and VM.
- To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
- To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
- To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
- To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
- To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
- To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Morcellation | Experimental | Procedure: Total Laparoscopic HysterectomyAbdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation. |
| Vaginal Morcellation | Experimental | Procedure: Total Laparoscopic HysterectomyVaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
- Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
- Age >18 years old
- Uterus >12 weeks, or >250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
- English and Spanish speaking
Key exclusion criteria (7 listed)
- Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
- Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
- Appendectomy for endometriosis is not excluded
- No chronic pain disorders requiring medical management (endometriosis can be included)
- Planned abdominal hysterectomy or vaginal hysterectomy candidates
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 |
|---|---|---|
| Total Laparoscopic HysterectomyParticipants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy | Procedure or surgery | Abdominal Morcellation, Vaginal Morcellation |
Primary outcome
Mean difference in total operating room time
Time frame: intraoperative
Total operating room time is defined as skin incision to skin closure
7 secondary outcomes
Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
Time frame: through study completion up to 6-weeks post-operatively
Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively
Time frame: through study completion up to 6-weeks post-operatively
Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
Time frame: through study completion up to 6-weeks post-operatively
Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
Time frame: through study completion up to 6-weeks post-operatively
Morcellation Time
Time frame: intraoperative
Rates of Post-Operative Complications
Time frame: through study completion up to 6-weeks post-operatively
Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
Time frame: after surgery to 2-weeks post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- BackgroundUS Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
- BackgroundUS Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
- Background: PubMed 29112659Siedhoff MT, Cohen SL. Tissue Extraction Techniques for Leiomyomas and Uteri During Minimally Invasive Surgery. Obstet Gynecol. 2017 Dec;130(6):1251-1260. doi: 10.1097/AOG.0000000000002334.
- Background: PubMed 25162248Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.
- Background: PubMed 26205578Solima E, Scagnelli G, Austoni V, Natale A, Bertulessi C, Busacca M, Vignali M. Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1244-6. doi: 10.1016/j.jmig.2015.07.007. Epub 2015 Jul 20.
- Background: PubMed 26400045Moawad GN, Abi KhalIL ED, Opoku-Anane J, Marfori CQ, Harman AC, Fisher S, Levy M, Robinson JK. Comparison of methods of morcellation: manual versus power. Acta Obstet Gynecol Scand. 2016 Jan;95(1):52-4. doi: 10.1111/aogs.12783. Epub 2015 Oct 19.
- Background: PubMed 28483536Meurs EAIM, Brito LG, Ajao MO, Goggins ER, Vitonis AF, Einarsson JI, Cohen SL. Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy. J Minim Invasive Gynecol. 2017 Jul-Aug;24(5):843-849. doi: 10.1016/j.jmig.2017.04.023. Epub 2017 May 5.
- Background: PubMed 26801067Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
- Background: PubMed 28586771Frasca C, Degli Esposti E, Arena A, Tuzzato G, Moro E, Martelli V, Seracchioli R. Can In-Bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial. Gynecol Obstet Invest. 2018;83(1):52-56. doi: 10.1159/000477171. Epub 2017 Jun 7.
- Background: PubMed 22704765Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.
- Background: PubMed 30075302Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019 May-Jun;26(4):702-708. doi: 10.1016/j.jmig.2018.07.020. Epub 2018 Aug 1.
- 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.
Kimberly A Kho, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Laparoscopic Hysterectomy in people with Abnormal Uterine Bleeding and Uterine Bleeding, run by University of Texas Southwestern Medical Center 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 5 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: finished, as of the sponsor's last update on 8 Nov 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean difference in total operating room time (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434066, which also lists 11 linked publications.
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 8 Nov 2024.