HysterectomyNCT03101098
Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus
A study testing Retroperitoneal liagation of uterine artery and Classical ligation of uterine artery in people with Hysterectomy, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Retroperitoneal liagation of uterine artery and Classical ligation of uterine artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2017to 1 Mar 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 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- absence of pregnancy at the time of presentation
- uterine volume between 12 and 18 weeks of gestation by pelvic examination
- appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Who cannot join
- any suggestion of malignant uterine or adnexal diseases
- any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
- an inability to understand and provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial
This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.
Read the detailed description
Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called "retroperitoneal TLH") is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.
- Conditions
- Hysterectomy
- Being tested
- Retroperitoneal liagation of uterine artery, Classical ligation of uterine artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroperitoneal liagation of uterine arteryProcedure or surgery
the site of ligation of uterine artery is the area that it originates from the internal iliac artery during TLH
Classical ligation of uterine arteryProcedure or surgery
the site of ligation of uterine artery is the area alongside the cervix
| Study group | Role | What they receive |
|---|---|---|
| Retroperitoneal hysterectomy | Experimental | In subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery, Receives: Procedure: Retroperitoneal liagation of uterine artery |
| Classical hysterectomy | Active comparator | The operative technique of classical total laparoscopic hysterectomy (TLH) performed in the control group was comparable to that of retroperitoneal TLH, except for one that coagulation and transection of uterine artery was achieved using an energy device alongside the cervix Receives: Procedure: Classical ligation of uterine artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative blood loss
Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.
Measured: Operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start10 Apr 2017
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: IRB did not approve this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD PhD, Study chair, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101098
- Sponsor's protocol ID
- 2017-02-001
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2017
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03101098
- Acronym / sponsor ID
- 2017-02-001
- Conditions
- Hysterectomy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: IRB did not approve this study.
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 4 Apr 2017 (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.
This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.
Detailed description
Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called "retroperitoneal TLH") is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retroperitoneal hysterectomy | Experimental | Procedure: Retroperitoneal liagation of uterine arteryIn subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery, |
| Classical hysterectomy | Active comparator | Procedure: Classical ligation of uterine arteryThe operative technique of classical total laparoscopic hysterectomy (TLH) performed in the control group was comparable to that of retroperitoneal TLH, except for one that coagulation and transection of uterine artery was achieved using an energy device alongside the cervix |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- absence of pregnancy at the time of presentation
- uterine volume between 12 and 18 weeks of gestation by pelvic examination
- appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Key exclusion criteria (3 listed)
- any suggestion of malignant uterine or adnexal diseases
- any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
- an inability to understand and provide written informed consent.
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 |
|---|---|---|
| Retroperitoneal liagation of uterine arterythe site of ligation of uterine artery is the area that it originates from the internal iliac artery during TLH | Procedure or surgery | Retroperitoneal hysterectomy |
| Classical ligation of uterine arterythe site of ligation of uterine artery is the area alongside the cervix | Procedure or surgery | Classical hysterectomy |
Primary outcome
Operative blood loss
Time frame: Operation day
Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Hysterectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Active, not recruitingPhase 2
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
Post Operative Analgesia
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Active, not recruiting
Clinical Assessment - HominisTM Surgical System
Hysterectomy
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.
Taejong Song, MD PhD study chair
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retroperitoneal liagation of uterine artery and Classical ligation of uterine artery in people with Hysterectomy, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 3 inclusion and 3 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: paused, as of the sponsor's last update on 3 Apr 2019. 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 South Korea. 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?
Results are not available in the source record.
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?
Operative blood loss (time frame: Operation day). 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 3 Apr 2019.