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

NCT ID: NCT04216979

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2020-07-30

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

Conditions

Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

laparoscopy entry policy

Intervention Type: PROCEDURE

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.

group A

these are the patient with palmars point as primary entry site

Group Type: EXPERIMENTAL

laparoscopy entry policy

Intervention Type: PROCEDURE

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.

group B

these are the patient with umbilicus as primary entry site

Group Type: EXPERIMENTAL

laparoscopy entry policy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

basem mohamed hamed khalil

lecturer of obstetrics and gynecology/ MD ob/gyn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig University

Zagazig, East, Egypt

Zagazig

Zagazig, East, Egypt

Countries

Egypt

Other Identifiers

5806-15-12-2019

Identifier Type: -

Identifier Source: org_study_id