Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy

NCT04788498 | Unknown

• 1 other identifier: M D 34 / 2021
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Ovarian Cyst Benign

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  The pain will be assessed by a numeric rating scale of 0-10

  at 24 hours ± 2 hour after the intervention

Secondary Outcomes (3)

• Operative time

  intraoperative

• the need for conversion to laparotomy

  intraoperative

• the need to add an additional trocar

  intraoperative

Study Arms (2)

Laparoendoscpoic single site surgery LESS

EXPERIMENTAL

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

Conventional multiport laparoscopy

ACTIVE COMPARATOR

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

Interventions

Laparoendoscpoic single site surgery LESS PROCEDURE

• A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp

Laparoendoscpoic single site surgery LESS

Conventional multiport laparoscopy PROCEDURE

• It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.

Conventional multiport laparoscopy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share