Gynecologic CancersBISGONCT07327125
Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery
A study testing Continuous Subcuticular Suture and Interrupted Skin Closure in people with Gynecologic Cancers and Surgical Wound Closure Techniques, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 60 years, women only
- Conditions the study is for
- Gynecologic Cancers, Surgical Wound Closure Techniques, Body Image
- What is being tested?
- Continuous Subcuticular Suture and Interrupted Skin Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul
mahmut yassa, +905396635484, mahmut_yassa@hotmail.com
About this study
Official title: 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).
Read more
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.
Read the 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.
- Being tested
- Continuous Subcuticular Suture, Interrupted Skin Closure
- Keywords
- surgical staples, Subcuticular Sutures, Gynecologic Oncology, Skin Closure Techniques, Body Image, Surgical Wound, Laparotomy, Cicatrix, Anxiety, Depression, Midline Incision, Wound Dehiscence, Wound Complications, Surgical Site Infection
- Medical subject headings
- Surgical Wound, Cicatrix, Anxiety Disorders, Depression, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Subcuticular SutureProcedure or surgery
Surgical skin closure performed using a continuous technique with absorbable suture material.
Interrupted Skin ClosureProcedure or surgery
Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.
| Study group | Role | What they receive |
|---|---|---|
| Subcuticular Suture Group | Experimental | Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material. Receives: Procedure: Continuous Subcuticular Suture |
| 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. Receives: Procedure: Interrupted Skin Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6.
Secondary outcomes (2)
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.
Measured: Post-operative Month 1, Month 3 and Month 6
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).
Measured: Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mahmut Yassa, Başakşehir Çam & Sakura City Hospital
- Investigators
- Bora Taşpınar, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327125
- Sponsor's protocol ID
- BCSSH-JINONK-01
- Acronym
- BISGO
- Status last verified
- Apr 2026
- First submitted
- 25 Dec 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skin Closure Techniques on Body Image and Mood in Gynecologic Oncology Patients
- ClinicalTrials.gov ID
- NCT07327125
- Acronym / sponsor ID
- BISGO / BCSSH-JINONK-01
- Keywords
- surgical staples, Subcuticular Sutures, Gynecologic Oncology, Skin Closure Techniques, Body Image, Surgical Wound, Laparotomy, Cicatrix
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subcuticular Suture Group | Experimental | Procedure: Continuous Subcuticular SuturePatients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material. |
| Interrupted Closure Group | Active comparator | Procedure: Interrupted Skin ClosurePatients 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. |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Subcuticular SutureSurgical skin closure performed using a continuous technique with absorbable suture material. | Procedure or surgery | Subcuticular Suture Group |
| Interrupted Skin ClosureSurgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures. | Procedure or surgery | Interrupted Closure Group |
Primary outcome
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.
2 secondary outcomes
Incidence of Wound Complications
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Gynecologic Cancers
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bora Taşpınar, MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Subcuticular Suture and Interrupted Skin Closure in people with Gynecologic Cancers and Surgical Wound Closure Techniques, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mahmut yassa, MD (+90 539 663 54 84, mahmut_yassa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.