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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216979
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
basem mohamed hamed khalil, Zagazig University

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

Condition or disease Intervention/treatment Phase
Gynecologic Disease Procedure: laparoscopy entry policy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: 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.
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.


Experimental: group A
these are the patient with palmars point as primary entry site
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.


Experimental: group B
these are the patient with umbilicus as primary entry site
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.





Primary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    we will compare the number of participants with vascular or intestinal injuries in both procedures

  3. 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 ]
    questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy



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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216979


Locations
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Egypt
Zagazig University Recruiting
Zagazig, East, Egypt, 44511
Contact: tolba ewida street 2 zagazig, 2    002/01004132040    basem@zu.edu.eg   
Contact       basemhamedobgyne@yahoo.com.sg   
Zagazig Active, not recruiting
Zagazig, East, Egypt, 44511
Sponsors and Collaborators
Zagazig University
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Responsible Party: basem mohamed hamed khalil, lecturer of obstetrics and gynecology/ MD ob/gyn, Zagazig University
ClinicalTrials.gov Identifier: NCT04216979    
Other Study ID Numbers: 5806-15-12-2019
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genital Diseases, Female