Gynecologic DiseaseNCT03988348
Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion
A study testing infraumbilical transverse incision and intraumbilical incision in people with Gynecologic Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- infraumbilical transverse incision and intraumbilical incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Aug 2019to Mar 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women subjected to direct trocar application as a part of any gynecologic procedure performed
Who cannot join
- Verres needle insertion.
- Patients with previous abdominal surgery and scar,
- umbilical hernia,
- previous laparoscopy or previous umbilical surgery,
- burns in the umbilical region;
- who have hyperpigmented skins.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abbas
Assiut, Cairo Governorate, 002
ahmed abbas, MD, 00201003385183, bmr90@hotmail.com
ahmed abbas
About this study
Official title: Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial
Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars
- Conditions
- Gynecologic Disease
- Being tested
- infraumbilical transverse incision, intraumbilical incision
- 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.
infraumbilical transverse incisionProcedure or surgery
a 10 mm infraumbilical transverse incision will be done to allow trocar to be inserted without undue resistance from the skin so that the trocar will pass through the fascia and the peritoneum with ease
intraumbilical incisionProcedure or surgery
right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | infraumbilical transverse incision will be done Receives: Procedure: infraumbilical transverse incision |
| control group | Active comparator | Direct intraumbilical transverse incision will be done Receives: Procedure: intraumbilical incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean difference in the duration of surgery
calculated from the onset of surgery till the end
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start4 Aug 2019
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (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.
- More trials run by Assiut 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
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988348
- Sponsor's protocol ID
- IUL
- Status last verified
- Mar 2020
- First submitted
- 13 Jun 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03988348
- Acronym / sponsor ID
- IUL
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Aug 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 17 Jun 2019 (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.
Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: infraumbilical transverse incisioninfraumbilical transverse incision will be done |
| control group | Active comparator | Procedure: intraumbilical incisionDirect intraumbilical transverse incision will be done |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women subjected to direct trocar application as a part of any gynecologic procedure performed
Key exclusion criteria (6 listed)
- Verres needle insertion.
- Patients with previous abdominal surgery and scar,
- umbilical hernia,
- previous laparoscopy or previous umbilical surgery,
- burns in the umbilical region;
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 |
|---|---|---|
| infraumbilical transverse incisiona 10 mm infraumbilical transverse incision will be done to allow trocar to be inserted without undue resistance from the skin so that the trocar will pass through the fascia and the peritoneum with ease | Procedure or surgery | study group |
| intraumbilical incisionright sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access | Procedure or surgery | control group |
Primary outcome
the mean difference in the duration of surgery
Time frame: 30 minutes
calculated from the onset of surgery till the end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infraumbilical transverse incision and intraumbilical incision in people with Gynecologic Disease, run by Assiut 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 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 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean difference in the duration of surgery (time frame: 30 minutes). 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 25 Mar 2020.