Uterine DiseasesNCT04808583
Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy
A study testing TLH with uterine artery ligation at its origin at the beginning of the operation and conventional TLH with uterine artery ligation after the cornual pedicles in people with Uterine Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the current study is to compare between the uterine artery ligation at its origin at the beginning of the operation and the conventional method after cornual pedicle regarding their efficacy to minimize operative time in patients undergoing total laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- TLH with uterine artery ligation at its origin at the beginning of the operation and conventional TLH with uterine artery ligation after the cornual pedicles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2021to 30 Oct 2022
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group (35-70 years old).
- Women consenting to have a total laparoscopic hysterectomy.
Who cannot join
- Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure)(All laparoscopic procedures are done under GA).
- Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction).
- Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood loss measurement)
- Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity affects airway pressure )
- Uncorrected anemic patients (Hemoglobin < 10 gm. /dl).(will affect the outcomes eg :
- Blood transfusion , hospital stay … etc )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of At-origin Uterine Artery Ligation Compared to Conventional Post-cornual Pedicle Ligation in Reducing Operative Time During Total Laparoscopic Hysterectomy
The aim of the current study is to compare between the uterine artery ligation at its origin at the beginning of the operation and the conventional method after cornual pedicle regarding their efficacy to minimize operative time in patients undergoing total laparoscopic hysterectomy.
Read the detailed description
- Approval of the study protocol will be sought from ASUMH ethical committee.
- The patients will be enrolled from the outpatient gynecology clinic of ASUMH.
- History, examination and routine investigations will be done to identify eligible patients.
- Written informed consent will be sought from the patients after proper counseling.
- Randomization: It will be a quasi-randomized clinical trial.
- Allocation: through "Alternation" method. Eligible patients will be randomized into one of the two study groups, where odd numbered patients (ex: patient number 1, 3, 5, etc. …) will be allocated to group (A) and even numbered patients (ex: patient number 2, 4, 6, etc. …) will be allocated to group (B) till full-filing the sample size. Before the operation, the patient will be allocated according to her number.
- Blinding: the patient will not be aware of the method used (either the conventional method or the At-origin ligation method) (single blinded).
- Patients who are randomized to group A will undergo TLH in the conventional method as follows: Positioning:The patient will be positioned in dorsal decubitus, under general anesthesia, with oral tracheal intubation. The legs will be positioned in 30°flexion; the arms along the body, and the buttocks extending slightly over the edge of the surgical table. The bladder will be catheterized. The surgeon will be positioned to the left of the patient, the primary assistant on the right, and the second assistant is responsible for uterine manipulation. Uterine Cannulation: Uterine cannulation will be performed using uterine manipulator. Hysterometry will be performed, the cervix will be dilated using Hegar dilators if needed, and the manipulator will be inserted under direct vision into the cervix. A Veress needle will be inserted at the umbilicus or supraumbilical site depending on the size of the uterus and abdomen will be insufflated with carbon dioxide at initial pressure of 20 mm Hg and maintenance at 15 mm Hg. A 10 mm trocar will be inserted blindly, and 10 mm telescope will be introduced through this port. Uterus and the adnexa will be visualized. Three additional 5mm ports are introduced: one along the left spino-umbilical line at the junction of medial 2/3rd and lateral 1/3rd, second port at right angles to the previous port, and a third 5 mm port placed around 2 cm below and to the right of umbilicus. The entire abdomen is surveyed before starting the procedure. The size of the uterus, presence of myomas, and adnexa and course of ureters are visualized (Poojari et al., 2014). Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014). Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides. Vault will be cut laparoscopically using monopolar hook and the specimen will be detached completely. The uterus with cervix will be delivered vaginally. The vaginal vault will then be sutured with number 0 delayed absorbable suture (vicryl).
- While patients randomized to group B will undergo TLH as follows: After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery. Dissecting the utero-vesical fold and pushing the bladder down will move the ureters laterally and decrease the risk of injuring them. The vasculature of the uterus will thus be secured, and this will be evidenced by the color change in the fundus, which will become pale. The cornual pedicles on one side (including the round ligament and either the utero-ovarian or infundibulopelvic ligments ) will then be desiccated and cut using the ligasure. The coagulated uterine pedicles will be cut. The utero-sacral and cardinal ligaments will be desiccated and cut. Then the opposite side pedicles will be taken care of. (Poojari et al., 2014).
- The operative time will be calculated and the total blood loss will be measured from the suction apparatus keeping in mind the amount of fluid used during irrigation. The urinary catheter will be removed after 6 hours and liquid diet will be started after peristalsis is established as evidenced by audible intestinal sounds. Follow up vital data and postoperative pain by visual analogue score and measuring postoperative hemoglobin, the patient will be discharged the following day and called for follow-up after 7 days.
- Conditions
- Uterine Diseases
- Being tested
- TLH with uterine artery ligation at its origin at the beginning of the operation, conventional TLH with uterine artery ligation after the cornual pedicles
- Keywords
- laparscopic hystrectomy uterine artery operative time
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLH with uterine artery ligation at its origin at the beginning of the operationProcedure or surgery
After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery
conventional TLH with uterine artery ligation after the cornual pediclesProcedure or surgery
Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014).
Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | conventional TLH with uterine artery ligation after the cornual pedicles Receives: Procedure: conventional TLH with uterine artery ligation after the cornual pedicles |
| Group (B) | Experimental | TLH with uterine artery ligation at its origin at the beginning of the operation Receives: Procedure: TLH with uterine artery ligation at its origin at the beginning of the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time in minutes
starting from port insertion till disconnecting the uterus from the vagina
Measured: Intraoperative (once for each patient starting from port insertion till disconnecting the uterus from the vagina .)
Secondary outcomes (4)
Blood loss in millimeters
blood loss in the operation will be measured from the suction apparatus keeping in mind the amount of fluid used during irrigation.
Measured: Intraoperative (once for each patient at the end of the operation .)
postoperative pain measured using visual analogue score.
VAS : visual analogue score where (0): no hurt - (10) : Hurts worst
Measured: 6 hours postoperative - 12 hours postoperative
Hospital stay (in days)
hospital stay in days after the procedure .
Measured: "through study completion, an average of 1 year".
Complications
(visceral , bladder or ureteric injuries).
Measured: during the procedure,immediately after the procedure .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start2 Jul 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Elrefaey, Ain Shams University
- Investigators
- Hazem M Sammour, MD, Study chair, Professor of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808583
- Sponsor's protocol ID
- UALO20
- Status last verified
- Nov 2022
- First submitted
- 22 Feb 2021
- Last updated
- 18 Nov 2022
- 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 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of At-origin Uterine Artery Ligation Compared to Conventional Post-cornual Pedicle Ligation in Reducing Operative Time During Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04808583
- Acronym / sponsor ID
- UALO20
- Conditions
- Uterine Diseases
- Keywords
- laparscopic hystrectomy uterine artery operative time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 22 Mar 2021 (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.
The aim of the current study is to compare between the uterine artery ligation at its origin at the beginning of the operation and the conventional method after cornual pedicle regarding their efficacy to minimize operative time in patients undergoing total laparoscopic hysterectomy.
Detailed description
- Approval of the study protocol will be sought from ASUMH ethical committee.
- The patients will be enrolled from the outpatient gynecology clinic of ASUMH.
- History, examination and routine investigations will be done to identify eligible patients.
- Written informed consent will be sought from the patients after proper counseling.
- Randomization: It will be a quasi-randomized clinical trial.
- Allocation: through "Alternation" method. Eligible patients will be randomized into one of the two study groups, where odd numbered patients (ex: patient number 1, 3, 5, etc. …) will be allocated to group (A) and even numbered patients (ex: patient number 2, 4, 6, etc. …) will be allocated to group (B) till full-filing the sample size. Before the operation, the patient will be allocated according to her number.
- Blinding: the patient will not be aware of the method used (either the conventional method or the At-origin ligation method) (single blinded).
- Patients who are randomized to group A will undergo TLH in the conventional method as follows: Positioning:The patient will be positioned in dorsal decubitus, under general anesthesia, with oral tracheal intubation. The legs will be positioned in 30°flexion; the arms along the body, and the buttocks extending slightly over the edge of the surgical table. The bladder will be catheterized. The surgeon will be positioned to the left of the patient, the primary assistant on the right, and the second assistant is responsible for uterine manipulation. Uterine Cannulation: Uterine cannulation will be performed using uterine manipulator. Hysterometry will be performed, the cervix will be dilated using Hegar dilators if needed, and the manipulator will be inserted under direct vision into the cervix. A Veress needle will be inserted at the umbilicus or supraumbilical site depending on the size of the uterus and abdomen will be insufflated with carbon dioxide at initial pressure of 20 mm Hg and maintenance at 15 mm Hg. A 10 mm trocar will be inserted blindly, and 10 mm telescope will be introduced through this port. Uterus and the adnexa will be visualized. Three additional 5mm ports are introduced: one along the left spino-umbilical line at the junction of medial 2/3rd and lateral 1/3rd, second port at right angles to the previous port, and a third 5 mm port placed around 2 cm below and to the right of umbilicus. The entire abdomen is surveyed before starting the procedure. The size of the uterus, presence of myomas, and adnexa and course of ureters are visualized (Poojari et al., 2014). Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014). Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides. Vault will be cut laparoscopically using monopolar hook and the specimen will be detached completely. The uterus with cervix will be delivered vaginally. The vaginal vault will then be sutured with number 0 delayed absorbable suture (vicryl).
- While patients randomized to group B will undergo TLH as follows: After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery. Dissecting the utero-vesical fold and pushing the bladder down will move the ureters laterally and decrease the risk of injuring them. The vasculature of the uterus will thus be secured, and this will be evidenced by the color change in the fundus, which will become pale. The cornual pedicles on one side (including the round ligament and either the utero-ovarian or infundibulopelvic ligments ) will then be desiccated and cut using the ligasure. The coagulated uterine pedicles will be cut. The utero-sacral and cardinal ligaments will be desiccated and cut. Then the opposite side pedicles will be taken care of. (Poojari et al., 2014).
- The operative time will be calculated and the total blood loss will be measured from the suction apparatus keeping in mind the amount of fluid used during irrigation. The urinary catheter will be removed after 6 hours and liquid diet will be started after peristalsis is established as evidenced by audible intestinal sounds. Follow up vital data and postoperative pain by visual analogue score and measuring postoperative hemoglobin, the patient will be discharged the following day and called for follow-up after 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Procedure: conventional TLH with uterine artery ligation after the cornual pediclesconventional TLH with uterine artery ligation after the cornual pedicles |
| Group (B) | Experimental | Procedure: TLH with uterine artery ligation at its origin at the beginning of the operationTLH with uterine artery ligation at its origin at the beginning of the operation |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age group (35-70 years old).
- Women consenting to have a total laparoscopic hysterectomy.
Key exclusion criteria (6 listed)
- Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure)(All laparoscopic procedures are done under GA).
- Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction).
- Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood loss measurement)
- Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity affects airway pressure )
- Uncorrected anemic patients (Hemoglobin < 10 gm. /dl).(will affect the outcomes eg :
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 with uterine artery ligation at its origin at the beginning of the operationAfter insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery | Procedure or surgery | Group (B) |
| conventional TLH with uterine artery ligation after the cornual pediclesCoagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014). Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides. | Procedure or surgery | Group (A) |
Primary outcome
Operative time in minutes
Time frame: Intraoperative (once for each patient starting from port insertion till disconnecting the uterus from the vagina .)
starting from port insertion till disconnecting the uterus from the vagina
4 secondary outcomes
Blood loss in millimeters
Time frame: Intraoperative (once for each patient at the end of the operation .)
postoperative pain measured using visual analogue score.
Time frame: 6 hours postoperative - 12 hours postoperative
Hospital stay (in days)
Time frame: "through study completion, an average of 1 year".
Complications
Time frame: during the procedure,immediately after the procedure .
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 18 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Uterine Diseases
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
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.
Hazem M Sammour, MD study chair
Professor of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLH with uterine artery ligation at its origin at the beginning of the operation and conventional TLH with uterine artery ligation after the cornual pedicles in people with Uterine Diseases, 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 2 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: finished, as of the sponsor's last update on 18 Nov 2022. 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?
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?
Operative time in minutes (time frame: Intraoperative (once for each patient starting from port insertion till disconnecting the uterus from the vagina .)). 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 18 Nov 2022.