Body Image, Gynecologic Cancers, Surgical Wound Closure Techniques
Conditions
Keywords
surgical staples, Subcuticular Sutures, Gynecologic Oncology, Skin Closure Techniques, Body Image, Surgical Wound, Laparotomy, Cicatrix, Anxiety, Depression, Midline Incision, Wound Dehiscence, Wound Complications, Surgical Site Infection
Brief summary
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.
Detailed description
Midline abdominal incisions are common in gynecologic oncology, yet the optimal skin closure technique to minimize scar-related psychological distress remains unclear. While staples offer speed, subcuticular sutures may provide superior cosmetic results. This study aims to fill the gap in the literature regarding the specific impact of these closure methods on body image and patient-reported outcomes in gynecologic cancer patients, beyond standard wound complication rates.
Interventions
PROCEDUREContinuous Subcuticular Suture
Surgical skin closure performed using a continuous technique with absorbable suture material.
PROCEDUREInterrupted Skin Closure
Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.
Sponsors
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized, parallel-group study. Participants are stratified based on Body Mass Index (\<30 vs. ≥30 kg/m²), incision length (\<15 cm vs. ≥15 cm), and intra-operative frozen section pathology result (Benign vs. Malignant). Randomization is performed intra-operatively, immediately after the frozen section result is available. Allocation uses a 1:1 ratio with permuted blocks of variable sizes (4, 6, 8) to ensure balanced assignment within each stratum. The randomization sequence was pre-generated using a fixed random seed (offline Excel file). Allocation concealment is maintained; the operating surgeon is blinded to future assignments and accesses the next allocation only after the patient is fully eligible.
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Body Image Scale (BIS) Score | Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6. | The Body Image Scale (BIS) is a 10-item questionnaire designed to assess body image changes in cancer patients. Each item is scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30. Higher scores indicate higher levels of body image distress and dissatisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wound Complications | Post-operative Month 1, Month 3 and Month 6 | Evaluation of surgical site complications including superficial or deep surgical site infection (SSI), wound dehiscence (separation of wound edges), seroma, and hematoma. Diagnosis is based on clinical examination and standard CDC criteria. |
| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score | Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6. | The HADS is a 14-item self-report screening scale. It consists of two subscales: Anxiety (HADS-A, 7 items) and Depression (HADS-D, 7 items). Each item is scored from 0 to 3. The maximum score for each subscale is 21. Higher scores indicate higher levels of anxiety or depression (worse outcome). |
Countries
Turkey (Türkiye)
Contacts
CONTACTmahmut yassa, MD
PRINCIPAL_INVESTIGATORBora Taşpınar, MD
Başakşehir Çam & Sakura City Hospital
Outcome results
None listed