Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery
NCT ID: NCT07327125
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2026-01-01
2028-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Subcuticular Suture Group
Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material.
Continuous Subcuticular Suture
Surgical skin closure performed using a continuous technique with absorbable suture material.
Interrupted Closure Group
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.
Interrupted Skin Closure
Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.
Interventions
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Continuous Subcuticular Suture
Surgical skin closure performed using a continuous technique with absorbable suture material.
Interrupted Skin Closure
Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
17 Years
60 Years
FEMALE
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Mahmut Yassa
Principal Investigator - Gynecologic Oncology Specialist
Principal Investigators
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Bora Taşpınar, MD
Role: PRINCIPAL_INVESTIGATOR
Başakşehir Çam & Sakura City Hospital
Central Contacts
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Other Identifiers
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BCSSH-JINONK-01
Identifier Type: -
Identifier Source: org_study_id
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