Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy

Ovarian Cyst Benign Clinical Trial

Official title:

Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04788498
• Other study ID #: M D 34 / 2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.

The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The patients are aged 18 to 45 years with BMI < 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no. 62. 2011:

• simple ovarian cysts >7cm and <15cm.

• Persistent simple cyst for more than 3 months.

• Symptomatic patients with complicated cyst (e.g. hemorrhagic cyst, torsion, etc)

Exclusion Criteria:

• • Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.

• Chronic pelvic pain, endometriosis or pelvic inflammatory diseases will be excluded to avoid pelvic adhesions and bias in the quantification of postoperative pain.

• Do not possess a native umbilicus giving difficult access to single port.

• The 'risk of malignancy index' (RMI) should be used to exclude those women at greater risk of malignancy. Using an RMI cut-off of 200, a sensitivity of 70% and specificity of 90% can be achieved. if features suggestive of malignancy are encountered, a gynecological oncologist should be consulted regarding further evaluation and staging.

• Benign teratomas for the difficulty of extraction after removal that affects the intraoperative maneuvers and time.

• Contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.

• Contraindication to general anesthesia as all laparoscopic procedures are done under GA.

• Contraindication to non-steroidal anti-inflammatories, paracetamol, or tramadol.

Related Conditions & MeSH terms

• Ovarian Cyst Benign
• Ovarian Cysts

Intervention

Procedure:
• Laparoendoscpoic single site surgery LESS
• A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp
• Conventional multiport laparoscopy
• It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	The pain will be assessed by a numeric rating scale of 0-10	at 24 hours ± 2 hour after the intervention
Secondary	Operative time	the time between the start of the incision up to the cutaneous closing of the trocar orifices	intraoperative
Secondary	the need for conversion to laparotomy	the need for conversion to laparotomy	intraoperative
Secondary	the need to add an additional trocar	the need to add an additional trocar	intraoperative