Hysterectomy, Benign Uterine DiseasesNCT03146299
Comparison of TLH and LAVH With Over Than 500g
A study testing TLH vs LAVH in people with Hysterectomy, Benign Uterine Diseases, run by Hanyang University Seoul Hospital.
Trial summary
Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer complications and shorter hospitalization compared to total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hysterectomy, Benign Uterine Diseases
- What is being tested?
- TLH vs LAVH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to Sep 2015
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Have the indication for hysterectomy for a supposed benign uterine disease
- Have a giant uterus of 500g or more
- Estimation of uterine weight more than 500g
- Uterine myoma size at 4 months or more after pregnancy due to pelvic examination
- The length of the long axis of one uterine myoma is more than 8cm or the length of the long axis for over 2 uterine myomas is more than 6cm
- Have been not pregnant at the time of presentation
- Have been appropriated medical status for laparoscopic surgery (surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Who cannot join
- Have a suspicion of malignancy or malignant tumors (cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, Endometrial cancer)
About this study
Official title: Comparison of Total Laparoscopic Hysterectomy and Laparoscopic Assisted Vaginal Hysterectomy With Over Giant Uterus of Than 500g: A Randomized Controlled Trial
Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer complications and shorter hospitalization compared to total abdominal hysterectomy.
However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show the postoperative complications were less frequent (3) and the postoperative recovery (4) and return to daily life were faster than total abdominal hysterectomy (3) even if it took longer operation time.
Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and indications are increasing. However, there has not yet been a direct comparison between TLH and VALH for large uterine surgery. In this study, we compared the results including the complications, hospitalization period and so on., in undergoing operation and post-operation between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Being tested
- TLH vs LAVH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLH vs LAVHProcedure or surgery
Also called TLH: Total Laparoscopic Hysterectomy, LAVH: Laparoscopic Assisted Vaginal Hysterectomy
TLH: The subjects undergoing laparoscopic hysterectomy with a giant uterus of 500 g or more
LAVH: The subjects undergoing Laparoscopic Assisted Vaginal Hysterectomy with a giant uterus of 500 g or more
| Study group | Role | What they receive |
|---|---|---|
| Group A: TLH | Active comparator | Not described Receives: Procedure: TLH vs LAVH |
| Group B: LAVH | Active comparator | Not described Receives: Procedure: TLH vs LAVH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Incidence of postoperative complications
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Apr 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hysterectomy, Benign Uterine DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joong Sub Choi, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146299
- Sponsor's protocol ID
- HYGY 4004
- Status last verified
- May 2017
- First submitted
- 6 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally MJ, Peterson HB, DeStefano F, Rubin GL, Ory HW. Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. The Collaborative Review of Sterilization. Am J Obstet Gynecol. 1982 Dec 1;144(7):841-8. doi: 10.1016/0002-9378(82)90362-3.
PubMed 7148906Carter JE, Ryoo J, Katz A. Laparoscopic-assisted vaginal hysterectomy: a case control comparative study with total abdominal hysterectomy. J Am Assoc Gynecol Laparosc. 1994 Feb;1(2):116-21. doi: 10.1016/s1074-3804(05)80773-x.
PubMed 9050472Hwang JL, Seow KM, Tsai YL, Huang LW, Hsieh BC, Lee C. Comparative study of vaginal, laparoscopically assisted vaginal and abdominal hysterectomies for uterine myoma larger than 6 cm in diameter or uterus weighing at least 450 g: a prospective randomized study. Acta Obstet Gynecol Scand. 2002 Dec;81(12):1132-8. doi: 10.1034/j.1600-0412.2002.811206.x.
PubMed 12519109
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Laparoscopic Hysterectomy and Laparoscopic Assisted Vaginal Hysterectomy With Over Giant Uterus of Than 500g: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03146299
- Acronym / sponsor ID
- HYGY 4004
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 May 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.
Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer complications and shorter hospitalization compared to total abdominal hysterectomy.
However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show the postoperative complications were less frequent (3) and the postoperative recovery (4) and return to daily life were faster than total abdominal hysterectomy (3) even if it took longer operation time.
Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and indications are increasing. However, there has not yet been a direct comparison between TLH and VALH for large uterine surgery. In this study, we compared the results including the complications, hospitalization period and so on., in undergoing operation and post-operation between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: TLH | Active comparator | Procedure: TLH vs LAVH |
| Group B: LAVH | Active comparator | Procedure: TLH vs LAVH |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have the indication for hysterectomy for a supposed benign uterine disease
- Have a giant uterus of 500g or more
- Estimation of uterine weight more than 500g
- Uterine myoma size at 4 months or more after pregnancy due to pelvic examination
- The length of the long axis of one uterine myoma is more than 8cm or the length of the long axis for over 2 uterine myomas is more than 6cm
Key exclusion criteria (1 listed)
- Have a suspicion of malignancy or malignant tumors (cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, Endometrial cancer)
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 |
|---|---|---|
| TLH vs LAVHAlso: TLH: Total Laparoscopic Hysterectomy, LAVH: Laparoscopic Assisted Vaginal HysterectomyTLH: The subjects undergoing laparoscopic hysterectomy with a giant uterus of 500 g or more LAVH: The subjects undergoing Laparoscopic Assisted Vaginal Hysterectomy with a giant uterus of 500 g or more | Procedure or surgery | Group A: TLH, Group B: LAVH |
Primary outcome
Postoperative complications
Time frame: 1 month after surgery
Incidence of postoperative complications
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 9 May 2017.
- Background: PubMed 7148906Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally MJ, Peterson HB, DeStefano F, Rubin GL, Ory HW. Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. The Collaborative Review of Sterilization. Am J Obstet Gynecol. 1982 Dec 1;144(7):841-8. doi: 10.1016/0002-9378(82)90362-3.
- Background: PubMed 9050472Carter JE, Ryoo J, Katz A. Laparoscopic-assisted vaginal hysterectomy: a case control comparative study with total abdominal hysterectomy. J Am Assoc Gynecol Laparosc. 1994 Feb;1(2):116-21. doi: 10.1016/s1074-3804(05)80773-x.
- Background: PubMed 12519109Hwang JL, Seow KM, Tsai YL, Huang LW, Hsieh BC, Lee C. Comparative study of vaginal, laparoscopically assisted vaginal and abdominal hysterectomies for uterine myoma larger than 6 cm in diameter or uterus weighing at least 450 g: a prospective randomized study. Acta Obstet Gynecol Scand. 2002 Dec;81(12):1132-8. doi: 10.1034/j.1600-0412.2002.811206.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TLH vs LAVH in people with Hysterectomy, Benign Uterine Diseases, run by Hanyang University Seoul Hospital.
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 7 inclusion and 1 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative complications (time frame: 1 month after surgery). 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 NCT03146299, which also lists 3 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 9 May 2017.