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Total Laparoscopic HysterectomyNCT06111404

Urinary Bladder Dissection During Total Laparoscopic Hysterectomy in Cases With Previous Cesarean Section

A study testing central urinary bladder dissection, Lateral urinary bladder dissection and Wolf laparoscopy tower in people with Total Laparoscopic Hysterectomy, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mobilization of the urinary bladder off of the cervix is an important step in total laparoscopic hysterectomy, and is always performed before dealing with the uterine pedicle. If the uterus is unscarred, bladder mobilization may not be technically difficult. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Total Laparoscopic Hysterectomy
What is being tested?
central urinary bladder dissection, Lateral urinary bladder dissection and Wolf laparoscopy tower
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteEgypt
Study dates
22 Jan 2023to 18 Jan 2025
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • .Patients undergoing total laparoscopic hysterectomy for benign conditions (e.g., dysfunctional uterine bleeding, adenomyosis and uterine fibroids) with presence of previous cesarean section scar.

Who cannot join

  • Patients with prior abdominal surgery other than CS.
  • Patients treated with concomitant surgery, including laparoscopic pelvic lymphadenectomy, posterior vaginal colporrhaphy and tension-free vaginal or obturator tape procedures.
  • Tubo-ovarian abscess.
  • Endometriosis.
  • Pelvic tuberculosis.
  • Pelvic organ prolapses. .Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure.
Show all 9Show fewer
  • .Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction).
  • Bleeding tendency (e.g. anticoagulants, platelets disorders)
  • Body mass index more than 35 Kg/m2

Trial locations and contacts

1 site in 1 country.

Ahmed Elawady, M.Sc contact

01091474582

megivemefromme@yahoo.co.uk

Egypt1 site, 1 recruiting
  • Mansoura University

    Al Mansurah

    Mansoura university, 2202772 050, med.deanoffice@mans.edu.eg

    Ahmed Elawady

    Recruiting

Other trials in Egypt

About this study

Official title: Lateral Versus Central Urinary Bladder Dissection During Total Laparoscopic Hysterectomy in Cases With Previous Cesarean Section: A Randomized Controlled Study

Mobilization of the urinary bladder off of the cervix is an important step in total laparoscopic hysterectomy, and is always performed before dealing with the uterine pedicle. If the uterus is unscarred, bladder mobilization may not be technically difficult. However, if the uterus is scarred, there can be adhesions not only between the uterus and the bladder but also to the anterior abdominal wall, which can make dissection challenging. Studies of the effects of closure or nonclosure of the peritoneum during cesarean delivery on adhesion formation have concluded that insufficient data are available and that adequately powered and designed trials are needed.

As regards the lateral approach, this space was first described by Dr. Shrish Sheth utilizing the utero-cervical broad ligament in post cesarean cases during vaginal hysterectomy. He described that the lateral area; the two leaves of broad ligament remains free and allows easy possibility for entry to dissect whether vaginally or abdominally. While in medial approach, a metal catheter was then inserted in the bladder. The catheter was rotated so the tip was pointing upward, to stretch the bladder pillars. The bladder was dissected with monopolar scissors with the catheter in place.

Read the detailed description

Hysterectomy is one of the most commonly performed gynecological operations. It is carried out because of a variety of indications, such as presence of dysfunctional uterine bleeding, myoma uteri, adenomyosis and adnexal mass. Hysterectomy can be performed using abdominal, vaginal, laparoscopic or robotic methods. According to the results from a study performed in the United States, the incidence rates for hysterectomies using abdominal, vaginal and laparoscopic methods are 66%, 22% and 12%, respectively.

There is still no consensus on which of these approaches is the optimum surgical method for hysterectomy. Abdominal hysterectomy is the most frequently performed approach, but current clinical practice mandates that, when appropriate, the surgical method should be vaginal rather than abdominal, since the former is associated with better outcomes and lower complication rates. Moreover, when vaginal hysterectomy is not feasible or not indicated, the surgical method should be laparoscopic, because total laparoscopic hysterectomy (TLH) provides a faster return to normal activity, shorter hospital stays, lower intraoperative bleeding and fewer wound infections, compared with abdominal hysterectomy. However, longer operating times and higher incidence of urinary system damage are seen in laparoscopic hysterectomies.

Cesarean section (CS) is the most commonly performed surgery on women and has increased significantly in the last 15 years. Various reasons account for the increase in CS, including an increase upon maternal request, changes in maternal demographics (e.g., increasing maternal age), changes in physician practice patterns, more conservative practice guidelines, and mounting legal pressures.

Because of the gradually increasing rates of cesarean sections (CSs) over the last two decades, the number of hysterectomized patients with previous CS has increased. In a recent review article, previously performed CSs were demonstrated to be an important risk factor for lower urinary tract injuries, and the recommendation that abdominal hysterectomy might be preferable for these patients was emphasized. TLH may be technically difficult in patients with previous CSs, due to surgical adhesions, and is associated with a higher risk of perioperative complications.

Mobilization of the urinary bladder off of the cervix is an important step in total laparoscopic hysterectomy, and is always performed before dealing with the uterine pedicle. If the uterus is unscarred, bladder mobilization may not be technically difficult. However, if the uterus is scarred, there can be adhesions not only between the uterus and the bladder but also to the anterior abdominal wall, which can make dissection challenging. Studies of the effects of closure or nonclosure of the peritoneum during cesarean delivery on adhesion formation have concluded that insufficient data are available and that adequately powered and designed trials are needed.

As regards the lateral approach, this space was first described by Dr. Shrish Sheth utilizing the utero-cervical broad ligament in post cesarean cases during vaginal hysterectomy. He described that the lateral area; the two leaves of broad ligament remains free and allows easy possibility for entry to dissect whether vaginally or abdominally.While in medial approach, a metal catheter was then inserted in the bladder. The catheter was rotated so the tip was pointing upward, to stretch the bladder pillars. The bladder was dissected with monopolar scissors with the catheter in place.

Being tested
central urinary bladder dissection, Lateral urinary bladder dissection, Wolf laparoscopy tower
Keywords
urinary bladder dissection, total laparoscopic hysterectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • central urinary bladder dissectionProcedure or surgery

    A metal catheter was then inserted in the bladder. The catheter was rotated so the tip was pointing upward, to stretch the bladder pillars. The bladder was dissected with monopolar scissors with the catheter in place. 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.

  • Lateral urinary bladder dissectionProcedure or surgery

    The broad ligament is dissected down till the uterine bundle is identified. Once the uterine vascular bundle is identified the space can be dissected just above these vessels to reach the lateral margins of cervix. Any fatty tissue should be moved with the bladder. Uterine vessels are then tackled by desiccation or ligation. Similar procedure is done on the opposite side. Once the bladder is completely dissected and lifted off from the cervix below, midline adhesions of the bladder and pillars can be gradually separated using sharp dissection or Ligasure staying near to cervix (Chen et al., 2007).

  • Wolf laparoscopy towerDevice

    set of instruments used for laparoscopic surgery

Study groups in NCT06111404
Study groupRoleWhat they receive
Group A (central group)Active comparatorA metal catheter was then inserted in the bladder. The catheter was rotated so the tip was pointing upward, to stretch the bladder pillars. The bladder was dissected with monopolar scissors with the catheter in place. 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.
Receives: Procedure: central urinary bladder dissection; Device: Wolf laparoscopy tower
Group B (lateral group)Active comparatorThe broad ligament is dissected down till the uterine bundle is identified. Once the uterine vascular bundle is identified the space can be dissected just above these vessels to reach the lateral margins of cervix. Any fatty tissue should be moved with the bladder. Uterine vessels are then tackled by desiccation or ligation. Similar procedure is done on the opposite side. Once the bladder is completely dissected and lifted off from the cervix below, midline adhesions of the bladder and pillars can be gradually separated using sharp dissection or Ligasure staying near to cervix (Chen et al., 2007).
Receives: Procedure: Lateral urinary bladder dissection; Device: Wolf laparoscopy tower

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of the procedure

    rate of urinary bladder injury during dissection

    Measured: during urinary bladder dissection intraoperative

Secondary outcomes (3)
  1. operative time

    time of primary port insertion till vault closure

    Measured: from time of primary port insertion till vault closure

  2. amount of blood loss

    total blood loss in vacuum during surgery

    Measured: during whole procedure

  3. late urological complications

    genitourinary fistula and ureteric injury

    Measured: intraoperative up to 2 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start22 Jan 2023
  3. Primary completion18 Jan 2025 (estimated)
  4. Study completion18 Jan 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111404
Sponsor's protocol ID
MD.22.11.720
Status last verified
Oct 2023
First submitted
3 Oct 2023
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: arms.inclusion and exclusion criteria

Questions about this trial

What is this clinical trial studying?

A study testing central urinary bladder dissection, Lateral urinary bladder dissection and Wolf laparoscopy tower in people with Total Laparoscopic Hysterectomy, run by Mansoura 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 1 inclusion and 9 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 1 Nov 2023. 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?

Contact Ahmed Elawady, M.Sc (01091474582, megivemefromme@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of the procedure (time frame: during urinary bladder dissection intraoperative). 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 1 Nov 2023.

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