Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery

Официальное название

Effect of Skin Closure Techniques on Body Image and Mood in Gynecologic Oncology Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Continuous Subcuticular Suture
  Surgical skin closure performed using a continuous technique with absorbable suture material.
• Процедура Interrupted Skin Closure
  Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.

Первичные конечные точки

• Change from Baseline in Body Image Scale (BIS) Score [Срок оценки: Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6.]

Вторичные конечные точки (2)

• Incidence of Wound Complications [Срок оценки: Post-operative Month 1, Month 3 and Month 6]
• Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score [Срок оценки: Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Başakşehir Çam and Sakura City Hospital — Istanbul

Идентификаторы

NCT: NCT07327125 · BCSSH-JINONK-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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