Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy

we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point

Study Overview

• Status: Unknown
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: laparoscopy entry policy

Detailed Description

All these cases will undergo:

1. History taking Patients are randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. The stomach will be emptied of secretions and air following endotracheal intubation. (This is most easily performed using a nasogastric tube.) The left upper quadrant will be inspected for scars and the upper abdomen palpated for hepatomegaly or splenomegaly. A 10-mm incision will be made over Palmer's point. Veress needle first will be used for insufflation and tests of safety will be considered.

A 10-mm port will be held vertically and the layers observed via a 10-mm laparoscope. A gentle rotating action in a vertical direction was used to allow the bladeless tip to separate the tissues.

The layers of the abdominal wall seen at Palmer's point are as follows:

• skin,
• subcutaneous fat,
• external oblique aponeurosis,
• internal oblique aponeurosis,
• transversalis muscle fibres,
• (sometimes) extraperitoneal fat,
• peritoneum. Once the peritoneum will be breached, the introducer will be carefully removed from the port. The laparoscope will be then reintroduced.

An extra 360° check was then performed to exclude a through-and-through bowel injury. The umbilicus was then inspected and any adhesions cleared using one or more 5-mm ports inserted under direct vision. At the end of the operation, the skin was closed using a single subcuticular suture Group (B):- The umbilicus is the primary entry site. First of all, the umbilicus is well cleaned with a piece of gauze with betadine or alcohol then small incision is done (10mm) in the umbilicus, veress needle is then inserted and tests of safety of intraperotineal insufflation are considered. 10 mm port is then introduced with gentle rotating action in a vertical direction to allow the bladeless tip to separate the tissues.

The layers of the abdominal wall seen at Palmer's point are as follows:

• skin
• linea alba
• peritoneum. Once the peritoneum is breached, the trocar will be carefully removed from the port. The laparoscope will then reintroduced.

An extra 360° check was then performed to exclude a through-and-through bowel injury. At the end of the operation, the skin will be closed using a single subcuticular suture

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • East
    • Zagazig, East, Egypt, 44511
      • Zagazig University
    • Zagazig, East, Egypt, 44511
      • Zagazig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients listed for diagnostic or operative laparoscopy.

Exclusion Criteria:

• • Splenomegaly

  • Hepatomegaly
  • previous left upper quadrant surgery.
  • midline laparotomy
  • umbilical surgery
  • presence of umbilical hernia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: randomization; Patients are randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.	Procedure: laparoscopy entry policy; Patients will be randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.
Experimental: group A; these are the patient with palmars point as primary entry site	Procedure: laparoscopy entry policy; Patients will be randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.
Experimental: group B; these are the patient with umbilicus as primary entry site	Procedure: laparoscopy entry policy; Patients will be randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point	the surgeon will calculate the time of surgery for similar cases in both groups and will compare between both groups according to the time factor	6 months
complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point	we will compare the number of participants with vascular or intestinal injuries in both procedures	6 months
coordination of the surgeon movement by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point	questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy	6 months

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: January 1, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 5806-15-12-2019

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
• product manufactured in and exported from the U.S.: No