Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy

NCT ID: NCT04788498

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Laparoendoscpoic single site surgery LESS

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Conventional multiport laparoscopy

Intervention Type: PROCEDURE

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

Interventions

Laparoendoscpoic single site surgery LESS

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Nabil

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

M D 34 / 2021

Identifier Type: -

Identifier Source: org_study_id