Adnexal PathologyNCT02739724
Benefits of Laparoscopy by Single Port Access for Adnexal Surgery
A study testing Adnexal surgery in people with Adnexal Pathology, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Introduction Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Pathology
- What is being tested?
- Adnexal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Apr 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presumed benign adnexal disease Adnexal pathologies treated between 7:00 AM and 10:00 PM Signed informed consent Patient presenting no contraindication to laparoscopy
Who cannot join
- Salpingitis and twist annexes. The patient does not fluently read French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
Introduction
Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So it seems interesting to conduct a new study about this technic. Aim of this study is to compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic laparoscopy (CL).
Read more
Materiel and Methods
We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring laparoscopic surgery for adnexal pathology with stratification for procedure (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative complications, duration of procedure, postoperative quality of life and immediate postoperative pain.
We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic scale 0-10). The estimated size of population number is 54 per group and 108 for the study.
Expected results
We expected a significant decrease of postoperative pain with SPA technic. This data will be interesting to promote use of SPA technic for adnexal surgery.
- Conditions
- Adnexal Pathology
- Being tested
- Adnexal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adnexal surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Classic laparoscopy | Active comparator | Patients will undergo laparoscopy surgery with classic laparoscopy technic. Receives: Procedure: Adnexal surgery |
| Laparoscopy single port access | Experimental | Patients will undergo laparoscopy surgery by single port access technic. Receives: Procedure: Adnexal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured with visual analog scale
Measured: Postoperative pain evaluation at 24 hours
Secondary outcomes (7)
Postoperative pain measured with visual analog scale
Measured: 2 hours, 4 hours, 6 hours, 1 month
timing in minutes between incision and suture
Measured: 4 hours
Blood lost in milliliters (mls)
Measured: 1 hour
Inpatient numbers of days
Measured: 1 month
Non steroid anti inflammatory numbers of pills taken
Measured: 1 month
number of convertion to laparotomy, Postoperative hernia
Measured: 1 month
visual analog scale for cosmetic satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adnexal PathologyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739724
- Sponsor's protocol ID
- 2015-A01217-42
- Other IDs
- 2015-32
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schmitt A, Crochet P, Pivano A, Tourette C, Faust C, Baumstarck K, Agostini A. The Effects of a Laparoscopy by Single-Port Endoscopic Access in Benign Adnexal Surgery: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2024 May;31(5):397-405. doi: 10.1016/j.jmig.2024.01.017. Epub 2024 Feb 2.
PubMed 38310954Schmitt A, Crochet P, Baumstark K, Tourette C, Poizac S, Pivano A, Boubli L, Cravello L, Agostini A. Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):38. doi: 10.1186/s13063-017-2429-y.
PubMed 29335017
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
- ClinicalTrials.gov ID
- NCT02739724
- Acronym / sponsor ID
- 2015-A01217-42
- Conditions
- Adnexal Pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- 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.
Introduction
Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So it seems interesting to conduct a new study about this technic. Aim of this study is to compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic laparoscopy (CL).
Materiel and Methods
We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring laparoscopic surgery for adnexal pathology with stratification for procedure (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative complications, duration of procedure, postoperative quality of life and immediate postoperative pain.
We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic scale 0-10). The estimated size of population number is 54 per group and 108 for the study.
Expected results
We expected a significant decrease of postoperative pain with SPA technic. This data will be interesting to promote use of SPA technic for adnexal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic laparoscopy | Active comparator | Procedure: Adnexal surgeryPatients will undergo laparoscopy surgery with classic laparoscopy technic. |
| Laparoscopy single port access | Experimental | Procedure: Adnexal surgeryPatients will undergo laparoscopy surgery by single port access technic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presumed benign adnexal disease Adnexal pathologies treated between 7:00 AM and 10:00 PM Signed informed consent Patient presenting no contraindication to laparoscopy
Key exclusion criteria (1 listed)
- Salpingitis and twist annexes. The patient does not fluently read French.
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 |
|---|---|---|
| Adnexal surgery | Procedure or surgery | Classic laparoscopy, Laparoscopy single port access |
Primary outcome
Postoperative pain measured with visual analog scale
Time frame: Postoperative pain evaluation at 24 hours
7 secondary outcomes
Postoperative pain measured with visual analog scale
Time frame: 2 hours, 4 hours, 6 hours, 1 month
timing in minutes between incision and suture
Time frame: 4 hours
Blood lost in milliliters (mls)
Time frame: 1 hour
Inpatient numbers of days
Time frame: 1 month
Non steroid anti inflammatory numbers of pills taken
Time frame: 1 month
number of convertion to laparotomy, Postoperative hernia
Time frame: 1 month
visual analog scale for cosmetic satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 38310954Schmitt A, Crochet P, Pivano A, Tourette C, Faust C, Baumstarck K, Agostini A. The Effects of a Laparoscopy by Single-Port Endoscopic Access in Benign Adnexal Surgery: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2024 May;31(5):397-405. doi: 10.1016/j.jmig.2024.01.017. Epub 2024 Feb 2.
- Derived from this study: PubMed 29335017Schmitt A, Crochet P, Baumstark K, Tourette C, Poizac S, Pivano A, Boubli L, Cravello L, Agostini A. Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):38. doi: 10.1186/s13063-017-2429-y.
- 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.
Urielle DESALBRES study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adnexal surgery in people with Adnexal Pathology, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 1 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 15 Apr 2016. 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 France. 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?
Postoperative pain measured with visual analog scale (time frame: Postoperative pain evaluation at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02739724, which also lists 2 linked publications.
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 15 Apr 2016.