Skin closure method and body image after gynecologic cancer surgery

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

This trial will test whether closing the midline belly incision with hidden (subcuticular) stitches versus staples or interrupted stitches changes body image and mood in women having open gynecologic cancer surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 17 Years to 60 Years
• Sex: Female
• Sponsor: Başakşehir Çam & Sakura City Hospital (other gov)
• Locations: 1 site (Istanbul)
• Trial ID: NCT07327125 on ClinicalTrials.gov

What this trial studies

This randomized trial enrolls women undergoing elective open gynecologic surgery through a vertical midline incision and assigns them to either interrupted skin closure (staples or separate mattress sutures) or continuous subcuticular sutures. Participants complete validated patient-reported measures including the Body Image Scale (BIS) and the Hospital Anxiety and Depression Scale (HADS) to capture cosmetic satisfaction and mood. The study also tracks wound complication rates such as infection and dehiscence to confirm safety of the subcuticular technique. Outcomes will compare cosmetic and psychological results between the two closure methods.

Who should consider this trial

Good fit: Women aged 18 or older scheduled for elective open gynecologic cancer surgery via a vertical midline laparotomy who can read and complete questionnaires and provide informed consent.

Not a fit: Patients having minimally invasive or emergency procedures, those with prior abdominal/pelvic radiotherapy, extreme BMI (<18 or >40), chronic immunosuppression, or cognitive/major psychiatric impairment were excluded and would not be eligible to benefit from the trial's findings.

Why it matters

Potential benefit: If successful, using subcuticular sutures could improve cosmetic satisfaction and body image and reduce anxiety or depression without increasing wound complications.

How similar studies have performed: Other surgical fields have reported better cosmetic outcomes with subcuticular sutures, but evidence specifically in gynecologic oncology is limited and mixed.

Eligibility criteria

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.

Where this trial is running

Istanbul

• Başakşehir Çam and Sakura City Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)

Study contacts

• Principal investigator: Bora Taşpınar, MD — Başakşehir Çam & Sakura City Hospital
• Study coordinator: mahmut yassa, MD

Conditions: Gynecologic Cancers, Surgical Wound Closure Techniques, Body Image, surgical staples, Subcuticular Sutures, Gynecologic Oncology, Skin Closure Techniques, Surgical Wound