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

NCT ID: NCT06111404

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-22
• Study Completion Date: 2025-01-18

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.

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.

Conditions

Total Laparoscopic Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A (central group)

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 Type: ACTIVE_COMPARATOR

central urinary bladder dissection

Intervention Type: 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.

Wolf laparoscopy tower

Intervention Type: DEVICE

set of instruments used for laparoscopic surgery

Group B (lateral group)

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 Type: ACTIVE_COMPARATOR

Lateral urinary bladder dissection

Intervention Type: 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).

Wolf laparoscopy tower

Intervention Type: DEVICE

set of instruments used for laparoscopic surgery

Interventions

central urinary bladder dissection

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.

Intervention Type: PROCEDURE

Lateral urinary bladder dissection

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).

Intervention Type: PROCEDURE

Wolf laparoscopy tower

set of instruments used for laparoscopic surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ahmed elawady, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura University

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Elawady, M.Sc

Role: CONTACT

megivemefromme@yahoo.co.uk

01091474582

Facility Contacts

Mansoura university

Role: primary

med.deanoffice@mans.edu.eg

2202772 050

Other Identifiers

MD.22.11.720

Identifier Type: -

Identifier Source: org_study_id