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

April 12, 2026 updated by: Mahmut Yassa, Başakşehir Çam & Sakura City Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcuticular Suture Group
Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material.
Procedure: Continuous Subcuticular Suture
Surgical skin closure performed using a continuous technique with absorbable suture material.
Active Comparator: 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.
Procedure: Interrupted Skin Closure
Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Body Image Scale (BIS) Score
Time Frame: 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.
Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Wound Complications
Time Frame: 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.
Post-operative Month 1, Month 3 and Month 6
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score
Time Frame: 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).
Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Investigators

  • Principal Investigator: Bora Taşpınar, MD, Başakşehir Çam & Sakura City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCSSH-JINONK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months and ending 5 years following article publication.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Body Image

Clinical Trials on Continuous Subcuticular Suture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe