AnatomyNCT04156932
Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial
A study testing uterine artery closure in people with Anatomy and Laparoscopy, run by Ospedale degli Infermi di Biella at 1 site in Italy.
Trial summary
One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the closure of the uterine artery, this vessel provides the greatest blood supply to the uterus. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Anatomy, Laparoscopy, Uterine Artery
- What is being tested?
- uterine artery closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 31 Aug 2020
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- benign disease
- elective laparoscopic hysterectomy
Who cannot join
- malignant disease
- emergency laparoscopic hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closure at the Origin of the Uterine Artery vs. Closure at the Cervico-isthmic Level in Laparoscopic Hysterectomy: a Randomized Clinical Trial
One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the closure of the uterine artery, this vessel provides the greatest blood supply to the uterus.
This step can be done in two ways: the surgeon can choose to interrupt the blood flow by closing the uterine artery in its last part, close to the uterus, or the surgeon can develop the anatomical spaces around the uterus into the deep pelvis, closing it to its origin, maintaining a minimally invasive approach in both cases.
Read more
Scientific research has tried to establish whether one of the two modalities is the best in reducing intraoperative blood loss and possible complications, but currently there is not enough evidence to recommend an approach rather than another.
The investigator has therefore decided to evaluate the results at the end of a laparoscopic hysterectomy in a scientifically rigorous manner.
- Conditions
- Anatomy, Laparoscopy, Uterine Artery, Hysterectomy
- Being tested
- uterine artery closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery closureProcedure or surgery
Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.
| Study group | Role | What they receive |
|---|---|---|
| OUC | Active comparator | Origin uterine artery closure Receives: Procedure: uterine artery closure |
| IUC | Active comparator | Cervical-isthmic uterine artery closure Receives: Procedure: uterine artery closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated blood loss
ml
Measured: End of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Dec 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnatomyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale degli Infermi di Biella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156932
- Sponsor's protocol ID
- 440/CE
- Status last verified
- Feb 2021
- First submitted
- 6 Nov 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
PubMed 26264829Aust T, Reyftmann L, Rosen D, Cario G, Chou D. Anterior approach to laparoscopic uterine artery ligation. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):792-5. doi: 10.1016/j.jmig.2011.07.008.
PubMed 22024265Simpson NA, Nimrod C, De Vermette R, Leblanc C, Fournier J. Sonographic evaluation of intervillous flow in early pregnancy: use of echo-enhancement agents. Ultrasound Obstet Gynecol. 1998 Mar;11(3):204-8. doi: 10.1046/j.1469-0705.1998.11030204.x.
PubMed 9589145Uccella S, Cromi A, Casarin J, Bogani G, Serati M, Gisone B, Pinelli C, Fasola M, Ghezzi F. Minilaparoscopic versus standard laparoscopic hysterectomy for uteri >/= 16 weeks of gestation: surgical outcomes, postoperative quality of life, and cosmesis. J Laparoendosc Adv Surg Tech A. 2015 May;25(5):386-91. doi: 10.1089/lap.2014.0478. Epub 2015 Apr 3.
PubMed 25839384Uccella S, Cromi A, Serati M, Casarin J, Sturla D, Ghezzi F. Laparoscopic hysterectomy in case of uteri weighing >/=1 kilogram: a series of 71 cases and review of the literature. J Minim Invasive Gynecol. 2014 May-Jun;21(3):460-5. doi: 10.1016/j.jmig.2013.08.706. Epub 2013 Sep 4.
PubMed 24012921
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure at the Origin of the Uterine Artery vs. Closure at the Cervico-isthmic Level in Laparoscopic Hysterectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04156932
- Acronym / sponsor ID
- 440/CE
- Conditions
- Anatomy, Laparoscopy, Uterine Artery, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ospedale degli Infermi di BiellaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 8 Nov 2019 (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.
One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the closure of the uterine artery, this vessel provides the greatest blood supply to the uterus.
This step can be done in two ways: the surgeon can choose to interrupt the blood flow by closing the uterine artery in its last part, close to the uterus, or the surgeon can develop the anatomical spaces around the uterus into the deep pelvis, closing it to its origin, maintaining a minimally invasive approach in both cases.
Scientific research has tried to establish whether one of the two modalities is the best in reducing intraoperative blood loss and possible complications, but currently there is not enough evidence to recommend an approach rather than another.
The investigator has therefore decided to evaluate the results at the end of a laparoscopic hysterectomy in a scientifically rigorous manner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OUC | Active comparator | Procedure: uterine artery closureOrigin uterine artery closure |
| IUC | Active comparator | Procedure: uterine artery closureCervical-isthmic uterine artery closure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- benign disease
- elective laparoscopic hysterectomy
Key exclusion criteria (2 listed)
- malignant disease
- emergency laparoscopic hysterectomy
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 |
|---|---|---|
| uterine artery closureInterruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin. | Procedure or surgery | IUC, OUC |
Primary outcome
estimated blood loss
Time frame: End of surgical procedure
ml
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 Feb 2021.
- Results publication: PubMed 26264829Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
- Results publication: PubMed 22024265Aust T, Reyftmann L, Rosen D, Cario G, Chou D. Anterior approach to laparoscopic uterine artery ligation. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):792-5. doi: 10.1016/j.jmig.2011.07.008.
- Results publication: PubMed 9589145Simpson NA, Nimrod C, De Vermette R, Leblanc C, Fournier J. Sonographic evaluation of intervillous flow in early pregnancy: use of echo-enhancement agents. Ultrasound Obstet Gynecol. 1998 Mar;11(3):204-8. doi: 10.1046/j.1469-0705.1998.11030204.x.
- Results publication: PubMed 25839384Uccella S, Cromi A, Casarin J, Bogani G, Serati M, Gisone B, Pinelli C, Fasola M, Ghezzi F. Minilaparoscopic versus standard laparoscopic hysterectomy for uteri >/= 16 weeks of gestation: surgical outcomes, postoperative quality of life, and cosmesis. J Laparoendosc Adv Surg Tech A. 2015 May;25(5):386-91. doi: 10.1089/lap.2014.0478. Epub 2015 Apr 3.
- Results publication: PubMed 24012921Uccella S, Cromi A, Serati M, Casarin J, Sturla D, Ghezzi F. Laparoscopic hysterectomy in case of uteri weighing >/=1 kilogram: a series of 71 cases and review of the literature. J Minim Invasive Gynecol. 2014 May-Jun;21(3):460-5. doi: 10.1016/j.jmig.2013.08.706. Epub 2013 Sep 4.
- Individual participant dataSharing planned: No
Related trials for Anatomy
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
Not yet recruitingObservational study
Anatomical Probability Model for Tibial and Peroneal Motor Entry Points
Lower Extremity Anatomy, Peripheral Nerve Anatomy
RecruitingObservational study
Systematic Anatomical Description of the Female Pelvic Retroperitoneum in Cadavers
Pelvic Anatomy, Retroperitoneum
Enrolling by invitation
Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access
Anatomy of the GSV for Rescue Peripheral IV Access
Recruiting
Serpentine vs Traditional Hydrophilic Guidewire Tracking in Complex Radial Anatomy
Transradial Access(TRA), Coronary Angiography (CAG)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterine artery closure in people with Anatomy and Laparoscopy, run by Ospedale degli Infermi di Biella at 1 site in Italy.
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 2 inclusion and 2 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 Feb 2021. 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 Italy. 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?
estimated blood loss (time frame: End of surgical procedure). 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 NCT04156932, which also lists 5 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 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.