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UnknownNCT04216979

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
96 (estimated)
Sponsor
Zagazig University · Other Government
Sex
Female
Age
10 Years – 60 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDURElaparoscopy entry policyPatients 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.

Timeline

Start date
2019-12-15
Primary completion
2020-07-30
Completion
2020-07-30
First posted
2020-01-03
Last updated
2020-07-17

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04216979. Inclusion in this directory is not an endorsement.