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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcuticular Suture Group | Experimental | Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material. |
|
| Interrupted Closure Group | Active Comparator | Patients in this group will undergo skin closure using interrupted techniques. The incision will be closed with either surgical staples (metal clips) or interrupted mattress sutures, depending on the standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Subcuticular Suture | Procedure | Surgical skin closure performed using a continuous technique with absorbable suture material. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Body Image Scale (BIS) Score | 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. | Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Wound Complications | 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. | Post-operative Month 1, Month 3 and Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mahmut yassa, MD | Contact | +90 539 663 54 84 | mahmut_yassa@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bora Taşpınar, MD | Başakşehir Çam & Sakura City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başakşehir Çam and Sakura City Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
De-identified individual participant data (IPD) that underlie the results reported in the article (text, tables, and figures) will be shared. This includes the data on body image scores, anxiety/depression scores, and wound complications. Data will be available beginning 6 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement.
Beginning 6 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal approved by an independent review committee or the Principal Investigator. Data will be shared for the purpose of achieving the aims in the approved proposal.
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D002921 | Cicatrix |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Interrupted Skin Closure | Procedure | Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures. |
|
| Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score |
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). |
| Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6. |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |