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

Z

Zagazig University

Status

Unknown

Conditions

Gynecologic Disease

Treatments

Procedure: laparoscopy entry policy

Study type

Interventional

Funder types

Other

Identifiers

NCT04216979
5806-15-12-2019

Details and patient eligibility

About

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

Full 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

Enrollment

96 estimated patients

Sex

Female

Ages

10 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

96 participants in 3 patient groups

randomization
Experimental group
Description:
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.
Treatment:
Procedure: laparoscopy entry policy
group A
Experimental group
Description:
these are the patient with palmars point as primary entry site
Treatment:
Procedure: laparoscopy entry policy
group B
Experimental group
Description:
these are the patient with umbilicus as primary entry site
Treatment:
Procedure: laparoscopy entry policy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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