Gynecologic DiseaseNCT04216979
Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
A study testing laparoscopy entry policy in people with Gynecologic Disease, run by Zagazig University at 2 sites in Egypt.
Trial summary
we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point Read more about this study
- Who is it for?
- Ages 10 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- laparoscopy entry policy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Dec 2019to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients listed for diagnostic or operative laparoscopy.
Who cannot join
- • Splenomegaly
- Hepatomegaly
- previous left upper quadrant surgery.
- midline laparotomy
- umbilical surgery
- presence of umbilical hernia
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Zagazig University
Zagazig, East, 44511
Zagazig
Zagazig, East, 44511
About this study
we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point
Read the detailed description
All these cases will undergo:
- 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
- Being tested
- laparoscopy entry policy
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy entry policyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| randomization | Experimental | 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. Receives: Procedure: laparoscopy entry policy |
| group A | Experimental | these are the patient with palmars point as primary entry site Receives: Procedure: laparoscopy entry policy |
| group B | Experimental | these are the patient with umbilicus as primary entry site Receives: Procedure: laparoscopy entry policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point
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
Measured: 6 months
complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point
we will compare the number of participants with vascular or intestinal injuries in both procedures
Measured: 6 months
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
questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start15 Dec 2019
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, basem mohamed hamed khalil, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216979
- Sponsor's protocol ID
- 5806-15-12-2019
- Status last verified
- Jan 2020
- First submitted
- 19 Dec 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
- ClinicalTrials.gov ID
- NCT04216979
- Acronym / sponsor ID
- 5806-15-12-2019
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| randomization | Experimental | Procedure: laparoscopy entry policyPatients 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 A | Experimental | Procedure: laparoscopy entry policythese are the patient with palmars point as primary entry site |
| group B | Experimental | Procedure: laparoscopy entry policythese are the patient with umbilicus as primary entry site |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients listed for diagnostic or operative laparoscopy.
Key exclusion criteria (6 listed)
- • Splenomegaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopy 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. | Procedure or surgery | group A, group B, randomization |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy entry policy in people with Gynecologic Disease, run by Zagazig University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.