Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cyst Benign
• Intervention / Treatment: Procedure: Laparoendoscpoic single site surgery LESS; Procedure: Conventional multiport laparoscopy

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoendoscpoic single site surgery LESS; 35 patients undergoing laparoscopic ovarian cystectomy A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp	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
Active Comparator: Conventional multiport laparoscopy; 35 patients undergoing laparoscopic ovarian cystectomy It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	The pain will be assessed by a numeric rating scale of 0-10	at 24 hours ± 2 hour after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	the time between the start of the incision up to the cutaneous closing of the trocar orifices	intraoperative
the need for conversion to laparotomy	the need for conversion to laparotomy	intraoperative
the need to add an additional trocar	the need to add an additional trocar	intraoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts
• Other Study ID Numbers: M D 34 / 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No