Vaginal HysterectomyPhase 4NCT03228654
Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy
A Phase 4 study testing Unipolar Electrocautery sealing of vessels and Purohit technique for vaginal hysterectomy in people with Vaginal Hysterectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof the development of alternative treatments, the incidence of hysterectomy doesn't appear to be declining. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Vaginal Hysterectomy
- What is being tested?
- Unipolar Electrocautery sealing of vessels and Purohit technique for vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2016to 1 Feb 2019
- Phase
- Phase 4
- 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
- uterine size <12 weeks.
- presence of benign cause for the hysterectomy e.g. fibroid uterus, perimenopausal beeding not responding to medical treatment or complex endometrial hyperplasia without atypia.
- Absence of significant scarring in the pelvis from previous surgeries.
Who cannot join
- Suspected or known gynecological malignancy.
- uterine size >12 weeks.
- Endometriosis
- Presence of adnexal mass.
- cervix flushed with the vagina.
- presence of significant scarring in the pelvic area from previous surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)
Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof the development of alternative treatments, the incidence of hysterectomy doesn't appear to be declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be performed in preference to abdominal hysterectomy.
Read the detailed description
A pilot prospective randomized clinical trial will be conducted at Ain shams University Maternity Hospital during the period from August 2016 to August 2018.
A sample size of 50 cases will be recruited from women presenting to the outpatient gynecologic clinic of Ain Shams University Maternity Hospital planned to undergo vaginal hysterectomy for benign cause. selected patients should be in age group from 40 to 70 years. Uterus size should be < 12 weeks with absence of significant scarring in the pelvis from previous surgeries. Endometriosis, Adnexal mass, malignancy, thinned out cervix should be excluded. After approval of the ethical committee , a detailed explanation of the procedure will e informed to the participant \& her approval to be involved in the study, an informed written consent will be taken. After that, included patients will be randomized into 2 groups each one include 25 patients. First group includes women who will undergo vaginal hysterectomy using monopolar electrocautery. Second group includes women who will undergo vaginal hysterectomy using Purohit's technique. Principles of Purohit technique are 1. Vaginal walls are incised by monopolar current(30-50W).2.A right angle forceps is used o elevate, hook, stretch, spread and retract all the lateral attacements of uterus \& vessels from their posterior aspects; tissues are coagulated using bipolar current (45 W) and divided between the prongs of forceps. 3. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.
Meanwhile the principles for vaginal hysterectomy using unipolar electrocautery are 1.Vaginal walls are incised by monopolar current(40 W) 2.A curved Bulldog clamp is applied just 0.5 cm lateral to uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lteral border of the uterus medial to the artery with maximum thickness 1 cm. 3. Uterine vessels are individually secured. 4. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.
- Conditions
- Vaginal Hysterectomy
- Being tested
- Unipolar Electrocautery sealing of vessels, Purohit technique for vaginal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar Electrocautery sealing of vesselsProcedure or surgery
Also called Monopolar Electrocautery sealing of vessels
- Vaginal walls are incised by monoplar current (40 W)
- A curved Bulldog Clamp is applied just 0.5 cm lateral to the uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lateral border of the uterus medial to the artery with maximum thickness 1 cm.
- uterine vessels are individually secured.
- Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space to approach the lateral attachements.
Purohit technique for vaginal hysterectomyProcedure or surgery
Also called Bipolar electrosurgical sealing of vessels during vaginal hysterctomy
using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy
| Study group | Role | What they receive |
|---|---|---|
| Unipolar electrocautery | Experimental | vaginal hysterectomy using Unipolar electrocautery Receives: Procedure: Unipolar Electrocautery sealing of vessels |
| Purohit's technique | Active comparator | Vaginal hysterectomy using Purohit's technique Receives: Procedure: Purohit technique for vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
assessment of blood loss by assessing blood loss amount in suction bottle as well as soaked guzes and towels.
Measured: 5 minutes after end if the procedure
Secondary outcomes (5)
operative time
will be accounted from time of vaginal mucous membrane incision till closure of the vault.
Measured: 5 minutes after end of the procedure
postoperative pain
pain scale will be used to assess pain
Measured: 6 hours postoperative
postoperative pain
pain scale will be used to assess pain
Measured: 12 hours postoperative
postoperative pain
pain scale will be used to assess pain
Measured: 24 hours postoperative
Hospital stay
number of days after the procedure the patient stay at the hospital
Measured: 1 week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Aug 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Why it stopped: No available device in the hospital to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HysterectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abass, Ain Shams University
- Investigators
- Ahmed A Tharwat, Ass. prof, Study director, Ain Shams UniversityAmr H Yehia, Ass.prof, Study chair, Ain Shams UniversityAlaa MA Karim El-din, ass. lect, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228654
- Sponsor's protocol ID
- Obs3514
- Status last verified
- Jan 2021
- First submitted
- 21 Jul 2017
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03228654
- Acronym / sponsor ID
- Obs3514
- Conditions
- Vaginal Hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No available device in the hospital to complete study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 25 Jul 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.
Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof the development of alternative treatments, the incidence of hysterectomy doesn't appear to be declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be performed in preference to abdominal hysterectomy.
Detailed description
A pilot prospective randomized clinical trial will be conducted at Ain shams University Maternity Hospital during the period from August 2016 to August 2018.
A sample size of 50 cases will be recruited from women presenting to the outpatient gynecologic clinic of Ain Shams University Maternity Hospital planned to undergo vaginal hysterectomy for benign cause. selected patients should be in age group from 40 to 70 years. Uterus size should be < 12 weeks with absence of significant scarring in the pelvis from previous surgeries. Endometriosis, Adnexal mass, malignancy, thinned out cervix should be excluded. After approval of the ethical committee , a detailed explanation of the procedure will e informed to the participant \& her approval to be involved in the study, an informed written consent will be taken. After that, included patients will be randomized into 2 groups each one include 25 patients. First group includes women who will undergo vaginal hysterectomy using monopolar electrocautery. Second group includes women who will undergo vaginal hysterectomy using Purohit's technique. Principles of Purohit technique are 1. Vaginal walls are incised by monopolar current(30-50W).2.A right angle forceps is used o elevate, hook, stretch, spread and retract all the lateral attacements of uterus \& vessels from their posterior aspects; tissues are coagulated using bipolar current (45 W) and divided between the prongs of forceps. 3. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.
Meanwhile the principles for vaginal hysterectomy using unipolar electrocautery are 1.Vaginal walls are incised by monopolar current(40 W) 2.A curved Bulldog clamp is applied just 0.5 cm lateral to uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lteral border of the uterus medial to the artery with maximum thickness 1 cm. 3. Uterine vessels are individually secured. 4. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unipolar electrocautery | Experimental | Procedure: Unipolar Electrocautery sealing of vesselsvaginal hysterectomy using Unipolar electrocautery |
| Purohit's technique | Active comparator | Procedure: Purohit technique for vaginal hysterectomyVaginal hysterectomy using Purohit's technique |
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)
- uterine size <12 weeks.
- presence of benign cause for the hysterectomy e.g. fibroid uterus, perimenopausal beeding not responding to medical treatment or complex endometrial hyperplasia without atypia.
- Absence of significant scarring in the pelvis from previous surgeries.
Key exclusion criteria (6 listed)
- Suspected or known gynecological malignancy.
- uterine size >12 weeks.
- Endometriosis
- Presence of adnexal mass.
- cervix flushed with the vagina.
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 |
|---|---|---|
| Unipolar Electrocautery sealing of vesselsAlso: Monopolar Electrocautery sealing of vessels1. Vaginal walls are incised by monoplar current (40 W) 2. A curved Bulldog Clamp is applied just 0.5 cm lateral to the uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lateral border of the uterus medial to the artery with maximum thickness 1 cm. 3. uterine vessels are individually secured. 4. Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space to approach the lateral attachements. | Procedure or surgery | Unipolar electrocautery |
| Purohit technique for vaginal hysterectomyAlso: Bipolar electrosurgical sealing of vessels during vaginal hysterctomyusing Bipolar electrosurgical sealing of vessels during vaginal hysterctomy | Procedure or surgery | Purohit's technique |
Primary outcome
Intraoperative blood loss
Time frame: 5 minutes after end if the procedure
assessment of blood loss by assessing blood loss amount in suction bottle as well as soaked guzes and towels.
5 secondary outcomes
operative time
Time frame: 5 minutes after end of the procedure
postoperative pain
Time frame: 6 hours postoperative
postoperative pain
Time frame: 12 hours postoperative
postoperative pain
Time frame: 24 hours postoperative
Hospital stay
Time frame: 1 week after procedure
Results and safety
The study was stopped early (reason given: No available device in the hospital to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: Yes
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Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Recruiting
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
Prolapse Pelvic, Hysterectomy
Recruiting
Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
Hysterectomy, Vaginal
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Hysterectomy, Benign Uterine Diseases
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.
Ahmed A Tharwat, Ass. prof study director
Ain Shams University
Amr H Yehia, Ass.prof study chair
Ain Shams University
Alaa MA Karim El-din, ass. lect principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unipolar Electrocautery sealing of vessels and Purohit technique for vaginal hysterectomy in people with Vaginal Hysterectomy, run by Ain Shams University 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: stopped early, as of the sponsor's last update on 20 Jan 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No available device in the hospital to complete 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?
Intraoperative blood loss (time frame: 5 minutes after end if the procedure). 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 20 Jan 2021.