Minimally Invasive Hysterectomy in Large UteriNCT02826304
Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri
A study testing Vaginal hysterectomy and Laparoscopic assisted vaginal hysterectomy in people with Minimally Invasive Hysterectomy in Large Uteri, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Minimally Invasive Hysterectomy in Large Uteri
- What is being tested?
- Vaginal hysterectomy and Laparoscopic assisted vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Jul 2016
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 70 years.
- Uterine weight more than 280gm. the weight will be estimated sonographically using algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)= 50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the dome of the fundus to the level of the external os and (W) is the maximum width of the uterus at the level of the cornua and (AP) is the anteroposterior diameter of the uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine length.
- Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.
Who cannot join
- Patients medically unfit for laparoscopy as severely compromised cardiac patients.
- Obese patients (BMI>30).
- Presence of endometriosis.
- Previous myomectomy
- Presence of adnexal mass
- Known or suspected gynecological malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes
Read the detailed description
Study setting : Ain Shams University Maternity Hospital Study Design : Pilot prospective randomized clinical trial Study population: The patients will be recruited from women presenting to the outpatient clinic of Ain Shams University Maternity Hospital planned to undergo hysterectomy for benign cause according to inclusion/ exclusion criteria which will be mentioned later.
Study duration : the study will be carried out during the period from August 2014 to August 2016.
Sample size: total of 50 cases will be included in the study to be divided into two groups, the first group will undergo vaginal hysterectomy and the second will undergo Laparoscopic assisted vaginal hysterectomy.
intervention: after approval of the ethical committee, a detailed explanation of the procedure will be informed to the participant and after her approval to involve in the study, an informed written consent will be taken. Detailed medical history will be obtained from all participants recruited in the study along with complete clinical examination and necessary laboratory and radiological investigations. Each patient will have a case record form in which the data regarding history, examination, investigations, operation costs and postoperative events will be recorded
- Being tested
- Vaginal hysterectomy, Laparoscopic assisted vaginal hysterectomy
- Keywords
- Vaginal Hysterectomy, Laparoscopic assisted vaginal hysterectomy, Large uteri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal hysterectomyProcedure or surgery
All the cases were performed by the same surgical team
- Incision is made at the anterior cervical lip below the bladder reflection
- Anterior peritoneal entry .
- Douglas pouch entry.
- The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated .
- Uterine artery clamping division and ligation
- After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy
- Utero-ovarian and round clamping-division and ligation ( in cases where oophorectomy was performed this part was done at the level of the infundibulo-pelvic ligament).
- Hemostasis
- The vaginal vault is closed after insertion of intraperitoneal drain and
Laparoscopic assisted vaginal hysterectomyProcedure or surgery
- Uterine manipulator was inserted through the cervix to mobilize the uterus
- Veress needle was inserted through the base of the umbilicus
- creation of pneumoperitoneum
- Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars
- The round and the utero-ovarian ligament are coagulated and divided.
- Dissection through the vesico-uterine space to displace bladder away from the cervix.
- Uterine artery was coagulated and divided laparoscopically
- anterior colpotomy over the cup of the uterine elevator.
- Vaginal part starts with opening of douglas pouch and clamping , division and ligation of uterosacral and cardinal ligaments followed by removal of the uterus and closure of the vault. reinflation to ensure proper hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| VH | Active comparator | Vaginal Hysterectomy for uteri larger than 280gm Receives: Procedure: Vaginal hysterectomy |
| LAVH | Active comparator | Laparoscopic assisted vaginal hysterectomy for uteri larger than 280gm Receives: Procedure: Laparoscopic assisted vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time of the procedure
In case of vaginal hysterectomy, the operative time will be measured from the vaginal incision to closure of the vaginal vault. in cases of Laparoscopic assisted vaginal hysterectomy, the time will be measured from the introduction of the laparoscopic camera port till stitching the laparoscopic incisions after ensuring adequate hemostasis. the time of any concomitant procedures was excluded
Measured: Range from 90 minutes to 210 minutes
Secondary outcomes (6)
Estimated intraoperative blood loss
intraoperative blood loss will be estimated via:
- - amount of blood in suction bottle.
- - Estimation based on number of soaked gauzes by weighing the gauzes used in the procedure before and after surgery ( each 1mg corresponds to 1ml of blood)
- - Drop in postoperative hemoglobin and hematocrit when compared with preoperative values.
Measured: the operative time of the procedure which range from 90 minutes to 210 minutes
Hospital costs
the costs of the following will be calculated:
- - Admission cost which include ward fee, pre and postoperative management costs and extra charges for post surgical complication.
- - anesthesia cost which includes expenses of anesthetics during the procedure. C)- operation cost which include operative material fee.
Measured: within the period of hospital admission which range from 2 to 8 days
intraoperative complications
- - need for blood transfusion
- - need for laparotomy due to either surgical difficulty or any complication
- - Bowel or urinary tract injuries
Measured: the operative time of the procedure which range from 90 minutes to 210 minutes
Postoperative Pain
Postoperative pain will be assessed using the visual analogue scale after the procedure by 6hrs, 12hrs and 24hrs.
Measured: the first 24hrs after the procedure
Postoperative complications
- - Need for blood transfusion
- - Vaginal vault or pelvic hematoma
- - surgical site infection
- - urinary tract infection
- - postoperative bowel or urinary tract complications
Measured: 1 month after the procedure
postoperative hospital stay
the hospital stay will be measured in hours
Measured: range from 24 hours to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive Hysterectomy in Large UteriStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mohamed Ibrahim Ali, Ain Shams Maternity Hospital
- Investigators
- Fekrya A Salama, PhD, Study chair, Ain Shams University Maternity HospitalAhmed A Tharwat, PhD, Study director, Ain Shams University Maternity HospitalWalid E Mohamed, PhD, Study director, Ain Shams University Maternity HospitalIbrahim M Ibrahim, PhD, Study director, Ain Shams University Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826304
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2016
- First submitted
- 28 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cho HY, Park ST, Kim HB, Kang SW, Park SH. Surgical outcome and cost comparison between total vaginal hysterectomy and laparoscopic hysterectomy for uteri weighing >500 g. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):115-9. doi: 10.1016/j.jmig.2013.07.013. Epub 2013 Aug 6.
PubMed 23932973Guvenal T, Ozsoy AZ, Kilcik MA, Yanik A. The availability of vaginal hysterectomy in benign gynecologic diseases: a prospective, non-randomized trial. J Obstet Gynaecol Res. 2010 Aug;36(4):832-7. doi: 10.1111/j.1447-0756.2010.01183.x.
PubMed 20666953Harb TS, Adam RA. Predicting uterine weight before hysterectomy: ultrasound measurements versus clinical assessment. Am J Obstet Gynecol. 2005 Dec;193(6):2122-5. doi: 10.1016/j.ajog.2005.07.014.
PubMed 16325627Harmanli OH, Gentzler CK, Byun S, Dandolu MH, Grody T. A comparison of abdominal and vaginal hysterectomy for the large uterus. Int J Gynaecol Obstet. 2004 Oct;87(1):19-23. doi: 10.1016/j.ijgo.2004.06.018.
PubMed 15464771Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
PubMed 11129939Johns DA, Carrera B, Jones J, DeLeon F, Vincent R, Safely C. The medical and economic impact of laparoscopically assisted vaginal hysterectomy in a large, metropolitan, not-for-profit hospital. Am J Obstet Gynecol. 1995 Jun;172(6):1709-15; discussion 1715-9. doi: 10.1016/0002-9378(95)91402-1.
PubMed 7778623Kim HB, Song JE, Kim GH, Cho HY, Lee KY. Comparison of clinical effects between total vaginal hysterectomy and total laparoscopic hysterectomy on large uteruses over 300 grams. J Obstet Gynaecol Res. 2010 Jun;36(3):656-60. doi: 10.1111/j.1447-0756.2010.01185.x.
PubMed 20598052Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.
PubMed 16934269Nazah I, Robin F, Jais JP, Jeffry L, Lelievre L, Camatte S, Taurelle R, Lecuru F. Comparison between bisection/morcellation and myometrial coring for reducing large uteri during vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy: results of a randomized prospective study. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1037-42. doi: 10.1034/j.1600-0412.2003.00278.x.
PubMed 14616278Sahin Y. Vaginal hysterectomy and oophorectomy in women with 12-20 weeks' size uterus. Acta Obstet Gynecol Scand. 2007;86(11):1359-69. doi: 10.1080/00016340701657258.
PubMed 17963064Seracchioli R, Venturoli S, Vianello F, Govoni F, Cantarelli M, Gualerzi B, Colombo FM. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002 Aug;9(3):333-8. doi: 10.1016/s1074-3804(05)60413-6.
PubMed 12101331Shiota M, Kotani Y, Umemoto M, Tobiume T, Shimaoka M, Hoshiai H. Total abdominal hysterectomy versus laparoscopically-assisted vaginal hysterectomy versus total vaginal hysterectomy. Asian J Endosc Surg. 2011 Nov;4(4):161-5. doi: 10.1111/j.1758-5910.2011.00104.x. Epub 2011 Sep 8.
PubMed 22776300Teoh TG. Vaginal hysterectomy for the large uterus. Med J Malaysia. 2001 Dec;56(4):460-2.
PubMed 12014766Wang CJ, Yen CF, Lee CL, Tashi T, Soong YK. Laparoscopically assisted vaginal hysterectomy for large uterus: a comparative study. Eur J Obstet Gynecol Reprod Biol. 2004 Aug 10;115(2):219-23. doi: 10.1016/j.ejogrb.2003.12.021.
PubMed 15262360Wang CJ, Yuen LT, Yen CF, Lee CL, Soong YK. A simplified method to decrease operative blood loss in laparoscopic-assisted vaginal hysterectomy for the large uterus. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):370-3. doi: 10.1016/s1074-3804(05)60053-9.
PubMed 15559351
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT02826304
- Acronym / sponsor ID
- 1
- Keywords
- Vaginal Hysterectomy, Laparoscopic assisted vaginal hysterectomy, Large uteri
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 7 Jul 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.
The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes
Detailed description
Study setting : Ain Shams University Maternity Hospital Study Design : Pilot prospective randomized clinical trial Study population: The patients will be recruited from women presenting to the outpatient clinic of Ain Shams University Maternity Hospital planned to undergo hysterectomy for benign cause according to inclusion/ exclusion criteria which will be mentioned later.
Study duration : the study will be carried out during the period from August 2014 to August 2016.
Sample size: total of 50 cases will be included in the study to be divided into two groups, the first group will undergo vaginal hysterectomy and the second will undergo Laparoscopic assisted vaginal hysterectomy.
intervention: after approval of the ethical committee, a detailed explanation of the procedure will be informed to the participant and after her approval to involve in the study, an informed written consent will be taken. Detailed medical history will be obtained from all participants recruited in the study along with complete clinical examination and necessary laboratory and radiological investigations. Each patient will have a case record form in which the data regarding history, examination, investigations, operation costs and postoperative events will be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VH | Active comparator | Procedure: Vaginal hysterectomyVaginal Hysterectomy for uteri larger than 280gm |
| LAVH | Active comparator | Procedure: Laparoscopic assisted vaginal hysterectomyLaparoscopic assisted vaginal hysterectomy for uteri larger than 280gm |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40 and 70 years.
- Uterine weight more than 280gm. the weight will be estimated sonographically using algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)= 50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the dome of the fundus to the level of the external os and (W) is the maximum width of the uterus at the level of the cornua and (AP) is the anteroposterior diameter of the uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine length.
- Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.
Key exclusion criteria (6 listed)
- Patients medically unfit for laparoscopy as severely compromised cardiac patients.
- Obese patients (BMI>30).
- Presence of endometriosis.
- Previous myomectomy
- Presence of adnexal mass
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 |
|---|---|---|
| Vaginal hysterectomyAll the cases were performed by the same surgical team 1. Incision is made at the anterior cervical lip below the bladder reflection 2. Anterior peritoneal entry . 3. Douglas pouch entry. 4. The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated . 5. Uterine artery clamping division and ligation 6. After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy 7. Utero-ovarian and round clamping-division and ligation ( in cases where oophorectomy was performed this part was done at the level of the infundibulo-pelvic ligament). 8. Hemostasis 9. The vaginal vault is closed after insertion of intraperitoneal drain and | Procedure or surgery | VH |
| Laparoscopic assisted vaginal hysterectomy1. Uterine manipulator was inserted through the cervix to mobilize the uterus 2. Veress needle was inserted through the base of the umbilicus 3. creation of pneumoperitoneum 4. Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars 5. The round and the utero-ovarian ligament are coagulated and divided. 6. Dissection through the vesico-uterine space to displace bladder away from the cervix. 7. Uterine artery was coagulated and divided laparoscopically 8. anterior colpotomy over the cup of the uterine elevator. 9. Vaginal part starts with opening of douglas pouch and clamping , division and ligation of uterosacral and cardinal ligaments followed by removal of the uterus and closure of the vault. reinflation to ensure proper hemostasis. | Procedure or surgery | LAVH |
Primary outcome
Operative time of the procedure
Time frame: Range from 90 minutes to 210 minutes
In case of vaginal hysterectomy, the operative time will be measured from the vaginal incision to closure of the vaginal vault. in cases of Laparoscopic assisted vaginal hysterectomy, the time will be measured from the introduction of the laparoscopic camera port till stitching the laparoscopic incisions after ensuring adequate hemostasis. the time of any concomitant procedures was excluded
6 secondary outcomes
Estimated intraoperative blood loss
Time frame: the operative time of the procedure which range from 90 minutes to 210 minutes
Hospital costs
Time frame: within the period of hospital admission which range from 2 to 8 days
intraoperative complications
Time frame: the operative time of the procedure which range from 90 minutes to 210 minutes
Postoperative Pain
Time frame: the first 24hrs after the procedure
Postoperative complications
Time frame: 1 month after the procedure
postoperative hospital stay
Time frame: range from 24 hours to 168 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Background: PubMed 23932973Cho HY, Park ST, Kim HB, Kang SW, Park SH. Surgical outcome and cost comparison between total vaginal hysterectomy and laparoscopic hysterectomy for uteri weighing >500 g. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):115-9. doi: 10.1016/j.jmig.2013.07.013. Epub 2013 Aug 6.
- Background: PubMed 20666953Guvenal T, Ozsoy AZ, Kilcik MA, Yanik A. The availability of vaginal hysterectomy in benign gynecologic diseases: a prospective, non-randomized trial. J Obstet Gynaecol Res. 2010 Aug;36(4):832-7. doi: 10.1111/j.1447-0756.2010.01183.x.
- Background: PubMed 16325627Harb TS, Adam RA. Predicting uterine weight before hysterectomy: ultrasound measurements versus clinical assessment. Am J Obstet Gynecol. 2005 Dec;193(6):2122-5. doi: 10.1016/j.ajog.2005.07.014.
- Background: PubMed 15464771Harmanli OH, Gentzler CK, Byun S, Dandolu MH, Grody T. A comparison of abdominal and vaginal hysterectomy for the large uterus. Int J Gynaecol Obstet. 2004 Oct;87(1):19-23. doi: 10.1016/j.ijgo.2004.06.018.
- Background: PubMed 11129939Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
- Background: PubMed 7778623Johns DA, Carrera B, Jones J, DeLeon F, Vincent R, Safely C. The medical and economic impact of laparoscopically assisted vaginal hysterectomy in a large, metropolitan, not-for-profit hospital. Am J Obstet Gynecol. 1995 Jun;172(6):1709-15; discussion 1715-9. doi: 10.1016/0002-9378(95)91402-1.
- Background: PubMed 20598052Kim HB, Song JE, Kim GH, Cho HY, Lee KY. Comparison of clinical effects between total vaginal hysterectomy and total laparoscopic hysterectomy on large uteruses over 300 grams. J Obstet Gynaecol Res. 2010 Jun;36(3):656-60. doi: 10.1111/j.1447-0756.2010.01185.x.
- Background: PubMed 16934269Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.
- Background: PubMed 14616278Nazah I, Robin F, Jais JP, Jeffry L, Lelievre L, Camatte S, Taurelle R, Lecuru F. Comparison between bisection/morcellation and myometrial coring for reducing large uteri during vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy: results of a randomized prospective study. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1037-42. doi: 10.1034/j.1600-0412.2003.00278.x.
- Background: PubMed 17963064Sahin Y. Vaginal hysterectomy and oophorectomy in women with 12-20 weeks' size uterus. Acta Obstet Gynecol Scand. 2007;86(11):1359-69. doi: 10.1080/00016340701657258.
- Background: PubMed 12101331Seracchioli R, Venturoli S, Vianello F, Govoni F, Cantarelli M, Gualerzi B, Colombo FM. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002 Aug;9(3):333-8. doi: 10.1016/s1074-3804(05)60413-6.
- Background: PubMed 22776300Shiota M, Kotani Y, Umemoto M, Tobiume T, Shimaoka M, Hoshiai H. Total abdominal hysterectomy versus laparoscopically-assisted vaginal hysterectomy versus total vaginal hysterectomy. Asian J Endosc Surg. 2011 Nov;4(4):161-5. doi: 10.1111/j.1758-5910.2011.00104.x. Epub 2011 Sep 8.
- Individual participant dataSharing planned: No
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.
Fekrya A Salama, PhD study chair
Ain Shams University Maternity Hospital
Ahmed A Tharwat, PhD study director
Ain Shams University Maternity Hospital
Walid E Mohamed, PhD study director
Ain Shams University Maternity 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 Vaginal hysterectomy and Laparoscopic assisted vaginal hysterectomy in people with Minimally Invasive Hysterectomy in Large Uteri, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2016. 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 Egypt. 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 time of the procedure (time frame: Range from 90 minutes to 210 minutes). 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 NCT02826304, which also lists 17 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 11 Jul 2016.