Clinical trial NCT04216979: Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
Official title: Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-01-03
Enrollment: 96
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point
timeFrame: 6 months
measure: complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: East
city: Zagazig
country: Egypt
facility: Zagazig
state: East
Study officials:
References: