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

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04216979
• Other study ID #: 5806-15-12-2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: January 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

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.

Locations

Country	Name	City	State
Egypt	Zagazig	Zagazig	East
Egypt	Zagazig University	Zagazig	East

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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