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

NCT06111404 | Unknown DMC

• 1 other identifier: MD.22.11.720
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Total Laparoscopic Hysterectomy

Keywords

urinary bladder dissection; total laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• Efficacy of the procedure

  rate of urinary bladder injury during dissection

  during urinary bladder dissection intraoperative

Secondary Outcomes (3)

• operative time

  from time of primary port insertion till vault closure

• amount of blood loss

  during whole procedure

• late urological complications

  intraoperative up to 2 months postoperative

Study Arms (2)

Group A (central group)

ACTIVE COMPARATOR

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.

Procedure: central urinary bladder dissection; Device: Wolf laparoscopy tower

Group B (lateral group)

ACTIVE COMPARATOR

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).

Procedure: Lateral urinary bladder dissection; Device: Wolf laparoscopy tower

Interventions

central urinary bladder dissection PROCEDURE

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.

Group A (central group)

Lateral urinary bladder dissection PROCEDURE

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).

Group B (lateral group)

Wolf laparoscopy tower DEVICE

set of instruments used for laparoscopic surgery

Group A (central group); Group B (lateral group)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

Study Officials

• ahmed elawady, M.Sc

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Elawady, M.Sc

CONTACT

01091474582; megivemefromme@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: November 1, 2023
• Study Start: January 22, 2023
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)