Surgical ProcedureNCT01803334
Impact of Marking Surgical Incision on Patient's Abdomen
A study testing Marking abdomen in people with Surgical Procedure, run by AdventHealth at 1 site in United States.
Trial summary
This is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have the anticipated incision marked with a washable marker on their abdomen. The control group will have preoperative counselling as usual. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Surgical Procedure
- What is being tested?
- Marking abdomen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 8 Jul 2013
- 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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 89
- Diagnosed with a benign surgical pathology
- Patient scheduled for elective minimally invasive gynecologic surgery
Who cannot join
- Have a diagnosis of gynecologic cancer
- History of prior laparoscopic surgery
- Emergency surgery
- Inability to provide informed consent
- Unable to follow up in the office for post operative visits
- Skin hypersensitivity or allergy to marker dye
- Positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Marking Surgical Incision Size and Location on the Patient's Abdomen During Preoperative Counseling in Minimally Invasive Gynecologic Surgery. A Randomized Control Trial.
This is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have the anticipated incision marked with a washable marker on their abdomen. The control group will have preoperative counselling as usual. After surgery, will assess patient's satisfaction with the incision scar.
Read the detailed description
This study is a prospective, randomized controlled trial examining the impact of marking the patient abdomen at the time of the preoperative visit on patient's satisfaction with scar appearance and symptoms, and pain at the incision site after undergoing minimally invasive gynecologic surgery for benign conditions.
We hypothesize that preoperative marking and instruction about incision expectations will improve patient's postoperative satisfaction with scar appearance and symptoms as well as decrease incision site pain compared to traditional preoperative counseling.
Patients that will undergo laparoscopic surgical intervention will be identified. The patient will be randomized into two groups: preoperative marking the abdomen versus conventional preoperative counseling.
If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.
After completed the surgery, information regarding type of surgery, reason for the procedure, estimated blood loss, surgical length, complications, location and size of abdominal incisions made on the patient's abdomen will be collected. Then at the 6 weeks post op visit, patient's satisfaction with the incision scar will be evaluated with a validated patient scar assessment questionnaire form and by one 5 point Likert scale question used in previous studies. The pain at rest at the incision site will be evaluated by a Visual Analog Pain Scale (VAS). Patients will also be asked to evaluate their generalized pain using a modified McGill Present Pain Intensity Scale.
- Conditions
- Surgical Procedure
- Being tested
- Marking abdomen
- Keywords
- surgical incision, laparoscopy, pain
- Medical subject headings
- Surgical Wound, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marking abdomenOther
If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit.
| Study group | Role | What they receive |
|---|---|---|
| Marking abdomen | Experimental | If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. Receives: Other: Marking abdomen |
| Control | No intervention | If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's expectation and satisfaction with incision scar will be evaluated with the patient scar assessment questionnaire and a 5 points Likert type scale question.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startJun 2012
- Primary completion8 Jul 2013
- Study completion8 Jul 2013
Why it stopped: Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ProcedureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose A carugno, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803334
- Sponsor's protocol ID
- 322259
- Status last verified
- Sep 2020
- First submitted
- 28 Feb 2013
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Marking Surgical Incision Size and Location on the Patient's Abdomen During Preoperative Counseling in Minimally Invasive Gynecologic Surgery. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01803334
- Acronym / sponsor ID
- 322259
- Conditions
- Surgical Procedure
- Keywords
- surgical incision, laparoscopy, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 8 Jul 2013 (actual)
- Study completion
- 8 Jul 2013 (actual)
- First posted
- 4 Mar 2013 (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.
This is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have the anticipated incision marked with a washable marker on their abdomen. The control group will have preoperative counselling as usual. After surgery, will assess patient's satisfaction with the incision scar.
Detailed description
This study is a prospective, randomized controlled trial examining the impact of marking the patient abdomen at the time of the preoperative visit on patient's satisfaction with scar appearance and symptoms, and pain at the incision site after undergoing minimally invasive gynecologic surgery for benign conditions.
We hypothesize that preoperative marking and instruction about incision expectations will improve patient's postoperative satisfaction with scar appearance and symptoms as well as decrease incision site pain compared to traditional preoperative counseling.
Patients that will undergo laparoscopic surgical intervention will be identified. The patient will be randomized into two groups: preoperative marking the abdomen versus conventional preoperative counseling.
If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.
After completed the surgery, information regarding type of surgery, reason for the procedure, estimated blood loss, surgical length, complications, location and size of abdominal incisions made on the patient's abdomen will be collected. Then at the 6 weeks post op visit, patient's satisfaction with the incision scar will be evaluated with a validated patient scar assessment questionnaire form and by one 5 point Likert scale question used in previous studies. The pain at rest at the incision site will be evaluated by a Visual Analog Pain Scale (VAS). Patients will also be asked to evaluate their generalized pain using a modified McGill Present Pain Intensity Scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marking abdomen | Experimental | Other: Marking abdomenIf the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. |
| Control | No intervention | –If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 89
- Diagnosed with a benign surgical pathology
- Patient scheduled for elective minimally invasive gynecologic surgery
Key exclusion criteria (7 listed)
- Have a diagnosis of gynecologic cancer
- History of prior laparoscopic surgery
- Emergency surgery
- Inability to provide informed consent
- Unable to follow up in the office for post operative visits
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 |
|---|---|---|
| Marking abdomenIf the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. | Other | Marking abdomen |
Primary outcome
Patient's expectation and satisfaction with incision scar will be evaluated with the patient scar assessment questionnaire and a 5 points Likert type scale question.
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
Jose A carugno, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marking abdomen in people with Surgical Procedure, run by AdventHealth 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Sep 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 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 was stopped early (reason given: Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the 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?
Patient's expectation and satisfaction with incision scar will be evaluated with the patient scar assessment questionnaire and a 5 points Likert type scale question. (time frame: 6 weeks). 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 30 Sep 2020.