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

Total Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111404
• Other study ID #: MD.22.11.720
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2023
• Est. completion date: January 18, 2025

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Ahmed Elawady, M.Sc
• Phone: 01091474582
• Email: megivemefromme[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: January 18, 2025
• Est. primary completion date: January 18, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Total Laparoscopic Hysterectomy

Intervention

Procedure:
• 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.
• 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).

Device:
• Wolf laparoscopy tower
set of instruments used for laparoscopic surgery

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the procedure	rate of urinary bladder injury during dissection	during urinary bladder dissection intraoperative
Secondary	operative time	time of primary port insertion till vault closure	from time of primary port insertion till vault closure
Secondary	amount of blood loss	total blood loss in vacuum during surgery	during whole procedure
Secondary	late urological complications	genitourinary fistula and ureteric injury	intraoperative up to 2 months postoperative