Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion

Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial

Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars

Study Overview

• Status: Unknown
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: infraumbilical transverse incision; Procedure: intraumbilical incision

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Recruiting
      • Ahmed Abbas
      • Contact: Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women subjected to direct trocar application as a part of any gynecologic procedure performed

Exclusion Criteria:

• Verres needle insertion.
• Patients with previous abdominal surgery and scar,
• umbilical hernia,
• previous laparoscopy or previous umbilical surgery,
• burns in the umbilical region;
• who have hyperpigmented skins.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; infraumbilical transverse incision will be done	Procedure: infraumbilical transverse incision; a 10 mm infraumbilical transverse incision will be done to allow trocar to be inserted without undue resistance from the skin so that the trocar will pass through the fascia and the peritoneum with ease
Active Comparator: control group; Direct intraumbilical transverse incision will be done	Procedure: intraumbilical incision; right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the mean difference in the duration of surgery	calculated from the onset of surgery till the end	30 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IUL

Drug and device information, study documents

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