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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04216979
Enrollment
96
Registered
2020-01-03
Start date
2019-12-15
Completion date
2020-07-30
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

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

Interventions

PROCEDURElaparoscopy 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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point6 monthsthe surgeon will calculate the time of surgery for similar cases in both groups and will compare between both groups according to the time factor
complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point6 monthswe will compare the number of participants with vascular or intestinal injuries in both procedures
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 point6 monthsquestionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026