Ovarian Cyst BenignNCT04788498
Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy
A study testing Laparoendoscpoic single site surgery LESS and Conventional multiport laparoscopy in people with Ovarian Cyst Benign, run by Ain Shams University.
Trial summary
The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst. The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Cyst Benign
- What is being tested?
- Laparoendoscpoic single site surgery LESS and Conventional multiport laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 May 2023
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The patients are aged 18 to 45 years with BMI < 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no. 62. 2011:
- simple ovarian cysts >7cm and <15cm.
- Persistent simple cyst for more than 3 months.
- Symptomatic patients with complicated cyst (e.g. hemorrhagic cyst, torsion, etc)
Who cannot join
- • Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.
- Chronic pelvic pain, endometriosis or pelvic inflammatory diseases will be excluded to avoid pelvic adhesions and bias in the quantification of postoperative pain.
- Do not possess a native umbilicus giving difficult access to single port.
- The 'risk of malignancy index' (RMI) should be used to exclude those women at greater risk of malignancy. Using an RMI cut-off of 200, a sensitivity of 70% and specificity of 90% can be achieved. if features suggestive of malignancy are encountered, a gynecological oncologist should be consulted regarding further evaluation and staging.
- Benign teratomas for the difficulty of extraction after removal that affects the intraoperative maneuvers and time.
- Contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
- Contraindication to general anesthesia as all laparoscopic procedures are done under GA.
- Contraindication to non-steroidal anti-inflammatories, paracetamol, or tramadol.
About this study
Official title: Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial
The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.
The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure
- Conditions
- Ovarian Cyst Benign
- Being tested
- Laparoendoscpoic single site surgery LESS, Conventional multiport laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoendoscpoic single site surgery LESSProcedure or surgery
- A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp
Conventional multiport laparoscopyProcedure or surgery
- It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.
| Study group | Role | What they receive |
|---|---|---|
| Laparoendoscpoic single site surgery LESS | Experimental | 35 patients undergoing laparoscopic ovarian cystectomy A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp Receives: Procedure: Laparoendoscpoic single site surgery LESS |
| Conventional multiport laparoscopy | Active comparator | 35 patients undergoing laparoscopic ovarian cystectomy It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area. Receives: Procedure: Conventional multiport laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The pain will be assessed by a numeric rating scale of 0-10
Measured: at 24 hours ± 2 hour after the intervention
Secondary outcomes (3)
Operative time
the time between the start of the incision up to the cutaneous closing of the trocar orifices
Measured: intraoperative
the need for conversion to laparotomy
the need for conversion to laparotomy
Measured: intraoperative
the need to add an additional trocar
the need to add an additional trocar
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cyst BenignStudies 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
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Nabil, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788498
- Sponsor's protocol ID
- M D 34 / 2021
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04788498
- Acronym / sponsor ID
- M D 34 / 2021
- Conditions
- Ovarian Cyst Benign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 9 Mar 2021 (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 aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.
The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoendoscpoic single site surgery LESS | Experimental | Procedure: Laparoendoscpoic single site surgery LESS35 patients undergoing laparoscopic ovarian cystectomy A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp |
| Conventional multiport laparoscopy | Active comparator | Procedure: Conventional multiport laparoscopy35 patients undergoing laparoscopic ovarian cystectomy It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patients are aged 18 to 45 years with BMI < 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no. 62. 2011:
Key exclusion criteria (8 listed)
- • Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.
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 |
|---|---|---|
| Laparoendoscpoic single site surgery LESS• A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp | Procedure or surgery | Laparoendoscpoic single site surgery LESS |
| Conventional multiport laparoscopy• It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area. | Procedure or surgery | Conventional multiport laparoscopy |
Primary outcome
Postoperative pain
Time frame: at 24 hours ± 2 hour after the intervention
The pain will be assessed by a numeric rating scale of 0-10
3 secondary outcomes
Operative time
Time frame: intraoperative
the need for conversion to laparotomy
Time frame: intraoperative
the need to add an additional trocar
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoendoscpoic single site surgery LESS and Conventional multiport laparoscopy in people with Ovarian Cyst Benign, run by Ain Shams University.
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 4 inclusion and 8 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative pain (time frame: at 24 hours ± 2 hour after the intervention). 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 9 Mar 2021.