Laparoscopic SurgeryNCT05565508
Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
A study testing new laparoscopic access technique for group a and Hasson's technique for laparoscopic access in group b in people with Laparoscopic Surgery, run by Zagazig University at 1 site in Egypt.
Trial summary
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- new laparoscopic access technique for group a and Hasson's technique for laparoscopic access in group b
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2020to 20 Jul 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.
- underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.
Who cannot join
- Patients with distended abdomen due to bowel obstruction.
- Patients with uncorrected coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery
Read the detailed description
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients
- Conditions
- Laparoscopic Surgery
- Being tested
- new laparoscopic access technique for group a, Hasson's technique for laparoscopic access in group b
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new laparoscopic access technique for group aProcedure or surgery
Also called new laparoscopic access technique
new laparoscopic access technique through the epigastric region
Hasson's technique for laparoscopic access in group bProcedure or surgery
Hasson's technique for laparoscopic access in group b
| Study group | Role | What they receive |
|---|---|---|
| new laparoscopic access technique | Experimental | in which we used our new laparoscopic access Receives: Procedure: new laparoscopic access technique for group a |
| Hasson's technique | Experimental | in which we used the well-known Hasson's technique for primary laparoscopic access Receives: Procedure: Hasson's technique for laparoscopic access in group b |
What is being measured
The primary outcome is the main question the study is designed to answer.
time needed to access the peritoneal cavity
time needed to access the peritoneal cavity
Measured: the first 15 minutes of operation
numbers of trials till the good peritoneal access achieved
numbers of trials till the good peritoneal access achieved
Measured: the first 15 minutes of operation
Secondary outcomes (1)
rate of complications
rate of complications
Measured: the first 15 minutes of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Mar 2020
- Primary completion17 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed lotfy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565508
- Sponsor's protocol ID
- zuh248
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
- ClinicalTrials.gov ID
- NCT05565508
- Acronym / sponsor ID
- zuh248
- Conditions
- Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 17 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 4 Oct 2022 (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.
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery
Detailed description
the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new laparoscopic access technique | Experimental | Procedure: new laparoscopic access technique for group ain which we used our new laparoscopic access |
| Hasson's technique | Experimental | Procedure: Hasson's technique for laparoscopic access in group bin which we used the well-known Hasson's technique for primary laparoscopic access |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.
- underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.
Key exclusion criteria (2 listed)
- Patients with distended abdomen due to bowel obstruction.
- Patients with uncorrected coagulopathy.
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 |
|---|---|---|
| new laparoscopic access technique for group aAlso: new laparoscopic access techniquenew laparoscopic access technique through the epigastric region | Procedure or surgery | new laparoscopic access technique |
| Hasson's technique for laparoscopic access in group bHasson's technique for laparoscopic access in group b | Procedure or surgery | Hasson's technique |
Primary outcome
time needed to access the peritoneal cavity
Time frame: the first 15 minutes of operation
time needed to access the peritoneal cavity
numbers of trials till the good peritoneal access achieved
Time frame: the first 15 minutes of operation
numbers of trials till the good peritoneal access achieved
1 secondary outcome
rate of complications
Time frame: the first 15 minutes of operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new laparoscopic access technique for group a and Hasson's technique for laparoscopic access in group b in people with Laparoscopic Surgery, run by Zagazig University at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 needed to access the peritoneal cavity (time frame: the first 15 minutes of operation). The study lists 2 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 4 Oct 2022.