## Protocol Section
### Identification Module
**NCT ID:** NCT04216979

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 5806-15-12-2019
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2020-07-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2020-07-17

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-07-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-12-15

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2020-01-03
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-19
**Study First Submit QC Date:** 2020-01-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Zagazig University

#### Responsible Party

**Investigator Affiliation:** Zagazig University

**Investigator Full Name:** basem mohamed hamed khalil

**Investigator Title:** lecturer of obstetrics and gynecology/ MD ob/gyn

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Gynecologic Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Procedure: laparoscopy entry policy

**Label:** randomization

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** these are the patient with palmars point as primary entry site

**Intervention Names:**

- Procedure: laparoscopy entry policy

**Label:** group A

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** these are the patient with umbilicus as primary entry site

**Intervention Names:**

- Procedure: laparoscopy entry policy

**Label:** group B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group A

- group B

- randomization

**Description:** 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.

**Name:** laparoscopy entry policy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point

**Time Frame:** 6 months

**Description:** we will compare the number of participants with vascular or intestinal injuries in both procedures

**Measure:** complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point

**Time Frame:** 6 months

**Description:** questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy

**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

**Time Frame:** 6 months

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 10 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zagazig

**Country:** Egypt

**Facility:** Zagazig University

**State:** East

**Zip:** 44511

**Location 2:**

**City:** Zagazig

**Country:** Egypt

**Facility:** Zagazig

**State:** East

**Zip:** 44511

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: HIGH

- As Found: Gynecologic Disease

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005831

- Term: Genital Diseases, Female

### Misc Info Module

- Version Holder: 2024-05-24
