This randomized clinical trial investigates the impact of two different skin closure techniques on body image and mood in women undergoing surgery for gynecologic cancers.
Patients undergoing elective surgery with a midline abdominal incision will be randomly assigned to one of two groups: 1. Interrupted Closure Group: The surgical incision is closed using either metal clips (staples) or separate mattress sutures (individual stitches). 2. Subcuticular Sutures Group: The surgical incision is closed using continuous stitches placed under the skin surface (aesthetic stitching).
The main goal of the study is to determine whether the method of wound closure affects a patient's perception of their body image, cosmetic satisfaction, and levels of anxiety or depression.
Additionally, the study aims to prove that the subcuticular suture technique is safe and does not increase the risk of wound complications (such as infection or wound separation) compared to the other method.
Participants will be asked to complete questionnaires before surgery, and again at 1, 3 and 6 months after surgery to track changes in their feelings and satisfaction with the scar.
Who can participate
Age range
17 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female participants aged 18 years or older.
* Patients scheduled for elective open gynecologic surgery for suspected or confirmed gynecologic malignancy.
* Surgery planned to be performed via a vertical midline laparotomy incision.
* Literate patients capable of reading, understanding, and completing the Body Image Scale (BIS) and Hospital Anxiety and Depression Scale (HADS).
* Patients who provide written informed consent to participate in the study.
Exclusion Criteria:
* History of prior radiotherapy to the abdominal or pelvic region.
* Patients currently receiving chronic immunosuppressive therapy.
* Body Mass Index (BMI) less than 18 kg/m\^2 or greater than 40 kg/m\^2.
* Presence of cognitive impairment, dementia, or Alzheimer's disease.
* Major psychiatric disorders that prevent the patient from understanding or completing the questionnaires.
* Patients undergoing emergency surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing different ways of closing the surgical wound after gynecologic surgery — can you explain which specific closure techniques are being studied and how they differ from what you would normally use in my case?
2Since this study is measuring something called the Body Image Scale score before and after surgery, what does that actually mean in practice, and how might my feelings about my body after surgery affect my overall recovery or quality of life?
3This trial is listed as 'Phase NA,' which typically means it's focused on comparing existing approaches rather than testing a brand-new treatment — does that mean there's already a safe standard of care for wound closure, and how would joining this study change anything about my actual surgical procedure?
4If I don't join this trial, would the wound closure technique you'd use on me be different from the ones being studied, and is one approach already considered better based on current evidence?
5Given that I'd be dealing with a gynecologic cancer diagnosis at the same time, how would you weigh the extra steps or assessments this study might involve against what I'll already be going through with treatment and recovery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Body Image Scale (BIS) Score