Pain, PostoperativeNCT04765306
Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain
A study testing Traditional Direct Fascial Closure and Fascial Closure Device in people with Pain, Postoperative, run by Jessica G Putman at 1 site in United States.
Trial summary
Our study aims to determine postoperative pain outcomes when comparing port site > 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Traditional Direct Fascial Closure and Fascial Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 14 Apr 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older.
- Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site > 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
- Patients willing and able to give informed consent.
- Patients capable and willing to return for follow up and complete pain diaries.
Who cannot join
- Patients unable to return for follow up.
- Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
- Patients undergoing laparoscopic surgery that does not require a port site >10 mm.
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Baroness Hospital
Chattanooga, Tennessee, 37403
About this study
Official title: Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial
Our study aims to determine postoperative pain outcomes when comparing port site > 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.
- Conditions
- Pain, Postoperative
- Being tested
- Traditional Direct Fascial Closure, Fascial Closure Device
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Direct Fascial ClosureDevice
Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
Fascial Closure DeviceDevice
Fascial closure using a fascial closure device under direct laparoscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Direct Fascial Closure | Active comparator | At the beginning of the laparoscopic procedure, all patients will receive 5 mL of 0.5% ropivacaine into each laparoscopic incision site. Patients in this group will have fascia closed under traditional direct visualization without laparoscopic guidance using a single interrupted suture of 0-vicryl. Receives: Device: Traditional Direct Fascial Closure |
| Fascial Closure Device | Active comparator | At the beginning of the laparoscopic procedure, all patients will receive 5 mL of 0.5% ropivacaine into each laparoscopic incision site. Patients in this group will have fascia closed using direct laparscopic visualization with the Carter-Thomason fascial closure device with a single interrupted suture of 0-vicryl. Receives: Device: Fascial Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores via Visual Analog Scale
A 20 mm difference in VAS score and a 2-unit difference on a 10-point pain scale have been described as a clinically significant difference between treatment groups.
Measured: Through 2 weeks postoperatively
Secondary outcomes (4)
Quantity of narcotics consumed in postoperative period
Number of tablets of narcotics consumed in postoperative period
Measured: Through 2 weeks postoperatively
Length of hospital stay
Length of hospital stay in days from day of surgery until discharge home
Measured: Through study completion, up to 6 months
Postoperative complication
Postoperative incisional infection, postoperative incisional hernia
Measured: Through 6 weeks postoperatively
Fascial closure operating time
Timing of fascial closure will start when the surgeon or surgical assistant reports s/he is beginning the fascial closure and stop after the suture is cut after tying.
Measured: Duration of fascial closure operating time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start5 Mar 2021
- Primary completion17 Mar 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica G Putman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica G Putman, University of Tennessee
- Investigators
- Todd Boren, MD, Principal investigator, University of Tennessee College of Medicine Gynecology OncologyJessica G Putman, MD, Study director, University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765306
- Sponsor's protocol ID
- 21-004
- Status last verified
- May 2022
- First submitted
- 17 Feb 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04765306
- Acronym / sponsor ID
- 21-004
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Jessica G PutmanUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 21 Feb 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.
Our study aims to determine postoperative pain outcomes when comparing port site > 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Direct Fascial Closure | Active comparator | Device: Traditional Direct Fascial ClosureAt the beginning of the laparoscopic procedure, all patients will receive 5 mL of 0.5% ropivacaine into each laparoscopic incision site. Patients in this group will have fascia closed under traditional direct visualization without laparoscopic guidance using a single interrupted suture of 0-vicryl. |
| Fascial Closure Device | Active comparator | Device: Fascial Closure DeviceAt the beginning of the laparoscopic procedure, all patients will receive 5 mL of 0.5% ropivacaine into each laparoscopic incision site. Patients in this group will have fascia closed using direct laparscopic visualization with the Carter-Thomason fascial closure device with a single interrupted suture of 0-vicryl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 or older.
- Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site > 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
- Patients willing and able to give informed consent.
- Patients capable and willing to return for follow up and complete pain diaries.
Key exclusion criteria (3 listed)
- Patients unable to return for follow up.
- Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
- Patients undergoing laparoscopic surgery that does not require a port site >10 mm.
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 |
|---|---|---|
| Traditional Direct Fascial ClosureFascial closure using traditional surgical instruments and suture without laparoscopic guidance. | Device | Traditional Direct Fascial Closure |
| Fascial Closure DeviceFascial closure using a fascial closure device under direct laparoscopic guidance. | Device | Fascial Closure Device |
Primary outcome
Postoperative pain scores via Visual Analog Scale
Time frame: Through 2 weeks postoperatively
A 20 mm difference in VAS score and a 2-unit difference on a 10-point pain scale have been described as a clinically significant difference between treatment groups.
4 secondary outcomes
Quantity of narcotics consumed in postoperative period
Time frame: Through 2 weeks postoperatively
Length of hospital stay
Time frame: Through study completion, up to 6 months
Postoperative complication
Time frame: Through 6 weeks postoperatively
Fascial closure operating time
Time frame: Duration of fascial closure operating time
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 12 May 2022.
- 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.
Todd Boren, MD principal investigator
University of Tennessee College of Medicine Gynecology Oncology
Jessica G Putman, MD study director
University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Direct Fascial Closure and Fascial Closure Device in people with Pain, Postoperative, run by Jessica G Putman at 1 site in United States.
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 3 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 12 May 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 United States. 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?
Postoperative pain scores via Visual Analog Scale (time frame: Through 2 weeks postoperatively). 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 12 May 2022.