Cesarean SectionGSMF-CSNCT07436520
Effect of Guide-Suture-Assisted Modified Fascial Closure on Postoperative Pain and Early Mobilization After Cesarean Section
A study testing Classical continuous fascial closure and Guide-suture-assisted modified fascial closure in people with Cesarean Section and Postoperative Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates whether a guide-suture-assisted modified fascial closure technique reduces postoperative pain and improves early functional recovery compared with classical continuous fascial closure in women undergoing elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Cesarean Section, Postoperative Pain
- What is being tested?
- Classical continuous fascial closure and Guide-suture-assisted modified fascial closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for elective cesarean section
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- American Society of Anesthesiologists (ASA) physical status class I or II
- Planned cesarean section with Pfannenstiel incision
- Ability to provide written informed consent
Who cannot join
- History of previous cesarean section
- Severe intra-abdominal adhesions
- Known coagulopathy or bleeding disorders
- Active infection
- Intraoperative complications
- Inability or unwillingness to provide informed consent
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Meram Medical Faculty Hospital
Konya, 42080
About this study
Official title: Effect of a Guide-Suture-Assisted Modified Fascial Closure Technique on Postoperative Pain and Early Mobilization After Cesarean Section: A Prospective, Single-Center, Randomized, Parallel-Group Trial With an Embedded Qualitative Component
This randomized controlled trial evaluates whether a guide-suture-assisted modified fascial closure technique reduces postoperative pain and improves early functional recovery compared with classical continuous fascial closure in women undergoing elective cesarean section.
Cesarean section is a common surgical procedure, and postoperative pain may delay mobilization and recovery. Fascial closure technique may influence postoperative pain by affecting tissue tension and alignment. The guide-suture-assisted modified closure technique is designed to improve fascial alignment and reduce mechanical tension during closure.
Read more
Participants undergoing elective cesarean section with Pfannenstiel incision are randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure. Postoperative pain intensity is assessed using validated pain scales, and functional recovery is evaluated by measuring walking distance during the early postoperative period.
The study aims to determine whether this modified surgical technique improves postoperative comfort and facilitates earlier mobilization compared with the conventional technique.
Read the detailed description
This prospective, single-center, randomized, parallel-group clinical trial evaluates the effect of a guide-suture-assisted modified continuous fascial closure technique on postoperative pain and functional recovery following elective cesarean section.
Eligible participants include women aged 18 to 35 years undergoing elective cesarean section with Pfannenstiel incision. Participants are randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure using a sealed-envelope randomization method.
All procedures are performed by the same experienced surgeon under spinal anesthesia using standardized surgical techniques. In the classical closure group, fascial closure is performed using continuous suturing with Vicryl 1-0 (polyglactin 910). In the modified closure group, a guide suture is first placed at the intended terminal corner of the fascial incision to improve alignment and reduce tissue tension, followed by continuous fascial closure using the same suture material.
Postoperative pain is assessed using the Visual Analog Scale (VAS), Numeric Rating Scale (NRS), and Short-Form McGill Pain Questionnaire (SF-MPQ) at 6, 12, 24, and 48 hours after surgery. Functional recovery is evaluated by measuring walking distance at the same time points. Postoperative analgesic use within 48 hours is also recorded.
The primary objective is to evaluate whether the modified fascial closure technique reduces early postoperative pain compared with classical continuous closure. Secondary objectives include assessment of functional recovery and analgesic requirements.
This study provides evidence regarding a simple surgical modification that may improve postoperative recovery following cesarean section.
- Conditions
- Cesarean Section, Postoperative Pain
- Being tested
- Classical continuous fascial closure, Guide-suture-assisted modified fascial closure
- Keywords
- Cesarean Section, Postoperative Pain,, Fascial Closure Surgical Technique, Early Mobilization, Obstetric Surgery, Pain Management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical continuous fascial closureProcedure or surgery
Fascial closure was performed using a conventional continuous suturing technique with Vicryl 1-0 (polyglactin 910). The suture was started at one corner of the fascial incision and continued to the opposite end without the use of a guide suture. All other surgical procedures were standardized.
Guide-suture-assisted modified fascial closureProcedure or surgery
A guide suture using Vicryl 1-0 (polyglactin 910) was placed at the terminal corner of the fascial incision prior to continuous closure. This guide suture was used to improve fascial alignment and reduce tissue tension. Continuous fascial closure was then performed using Vicryl 1-0. All other surgical procedures were standardized.
| Study group | Role | What they receive |
|---|---|---|
| Classical Continuous Fascial Closure | Active comparator | Participants underwent elective cesarean section with Pfannenstiel incision. Fascial closure was performed using the conventional continuous suturing technique with Vicryl 1-0 (polyglactin 910). All other surgical steps were standardized. Receives: Procedure: Guide-suture-assisted modified fascial closure |
| Guide-Suture-Assisted Modified Fascial Closure | Experimental | Participants underwent elective cesarean section with Pfannenstiel incision. A guide suture was placed at the intended terminal corner of the fascial incision before continuous closure to improve alignment and reduce tissue tension. Continuous fascial closure was then completed using Vicryl 1-0 (polyglactin 910). Receives: Procedure: Classical continuous fascial closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured by Visual Analog Scale (VAS)
Postoperative pain intensity is assessed using a 0-10 Visual Analog Scale (VAS), where higher scores indicate greater pain severity. Pain scores are recorded at 6, 12, 24, and 48 hours following surgery and compared between the classical continuous fascial closure group and the guide-suture-assisted modified fascial closure group.
Measured: 6, 12, 24, and 48 hours after cesarean section
Secondary outcomes (4)
Pain intensity during movement measured by Numeric Rating Scale (NRS)
Pain during movement is assessed using a 0-10 Numeric Rating Scale (NRS), where higher scores indicate greater pain intensity. Scores are recorded at each postoperative time point.
Measured: 6, 12, 24, and 48 hours after cesarean section
Pain quality measured by Short-Form McGill Pain Questionnaire (SF-MPQ)
Pain quality and intensity are evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ), which assesses sensory and affective components of pain.
Measured: 6, 12, 24, and 48 hours after cesarean section
Functional recovery measured by walking distance
Functional recovery is assessed by measuring walking distance in meters at each postoperative time point. Greater walking distance indicates better functional recovery.
Measured: 6, 12, 24, and 48 hours after cesarean section
Postoperative analgesic consumption
The type and frequency of analgesic medications administered during the first 48 hours after surgery are recorded and compared between study groups.
Measured: Within 48 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Oct 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Participants were randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure. Each participant received only one intervention, and outcomes were compared between parallel groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Energin, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436520
- Sponsor's protocol ID
- 2025/6054
- Acronym
- GSMF-CS
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to privacy and ethical restrictions. Data may be available from the corresponding author upon reasonable request and with appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Guide-Suture-Assisted Modified Fascial Closure Technique on Postoperative Pain and Early Mobilization After Cesarean Section: A Prospective, Single-Center, Randomized, Parallel-Group Trial With an Embedded Qualitative Component
- ClinicalTrials.gov ID
- NCT07436520
- Acronym / sponsor ID
- GSMF-CS / 2025/6054
- Conditions
- Cesarean Section, Postoperative Pain
- Keywords
- Cesarean Section, Postoperative Pain,, Fascial Closure Surgical Technique, Early Mobilization, Obstetric Surgery, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Feb 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 controlled trial evaluates whether a guide-suture-assisted modified fascial closure technique reduces postoperative pain and improves early functional recovery compared with classical continuous fascial closure in women undergoing elective cesarean section.
Cesarean section is a common surgical procedure, and postoperative pain may delay mobilization and recovery. Fascial closure technique may influence postoperative pain by affecting tissue tension and alignment. The guide-suture-assisted modified closure technique is designed to improve fascial alignment and reduce mechanical tension during closure.
Participants undergoing elective cesarean section with Pfannenstiel incision are randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure. Postoperative pain intensity is assessed using validated pain scales, and functional recovery is evaluated by measuring walking distance during the early postoperative period.
The study aims to determine whether this modified surgical technique improves postoperative comfort and facilitates earlier mobilization compared with the conventional technique.
Detailed description
This prospective, single-center, randomized, parallel-group clinical trial evaluates the effect of a guide-suture-assisted modified continuous fascial closure technique on postoperative pain and functional recovery following elective cesarean section.
Eligible participants include women aged 18 to 35 years undergoing elective cesarean section with Pfannenstiel incision. Participants are randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure using a sealed-envelope randomization method.
All procedures are performed by the same experienced surgeon under spinal anesthesia using standardized surgical techniques. In the classical closure group, fascial closure is performed using continuous suturing with Vicryl 1-0 (polyglactin 910). In the modified closure group, a guide suture is first placed at the intended terminal corner of the fascial incision to improve alignment and reduce tissue tension, followed by continuous fascial closure using the same suture material.
Postoperative pain is assessed using the Visual Analog Scale (VAS), Numeric Rating Scale (NRS), and Short-Form McGill Pain Questionnaire (SF-MPQ) at 6, 12, 24, and 48 hours after surgery. Functional recovery is evaluated by measuring walking distance at the same time points. Postoperative analgesic use within 48 hours is also recorded.
The primary objective is to evaluate whether the modified fascial closure technique reduces early postoperative pain compared with classical continuous closure. Secondary objectives include assessment of functional recovery and analgesic requirements.
This study provides evidence regarding a simple surgical modification that may improve postoperative recovery following cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either classical continuous fascial closure or guide-suture-assisted modified continuous fascial closure. Each participant received only one intervention, and outcomes were compared between parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Classical Continuous Fascial Closure | Active comparator | Procedure: Guide-suture-assisted modified fascial closureParticipants underwent elective cesarean section with Pfannenstiel incision. Fascial closure was performed using the conventional continuous suturing technique with Vicryl 1-0 (polyglactin 910). All other surgical steps were standardized. |
| Guide-Suture-Assisted Modified Fascial Closure | Experimental | Procedure: Classical continuous fascial closureParticipants underwent elective cesarean section with Pfannenstiel incision. A guide suture was placed at the intended terminal corner of the fascial incision before continuous closure to improve alignment and reduce tissue tension. Continuous fascial closure was then completed using Vicryl 1-0 (polyglactin 910). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Scheduled for elective cesarean section
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- American Society of Anesthesiologists (ASA) physical status class I or II
- Planned cesarean section with Pfannenstiel incision
Key exclusion criteria (7 listed)
- History of previous cesarean section
- Severe intra-abdominal adhesions
- Known coagulopathy or bleeding disorders
- Active infection
- Intraoperative complications
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 |
|---|---|---|
| Classical continuous fascial closureFascial closure was performed using a conventional continuous suturing technique with Vicryl 1-0 (polyglactin 910). The suture was started at one corner of the fascial incision and continued to the opposite end without the use of a guide suture. All other surgical procedures were standardized. | Procedure or surgery | Guide-Suture-Assisted Modified Fascial Closure |
| Guide-suture-assisted modified fascial closureA guide suture using Vicryl 1-0 (polyglactin 910) was placed at the terminal corner of the fascial incision prior to continuous closure. This guide suture was used to improve fascial alignment and reduce tissue tension. Continuous fascial closure was then performed using Vicryl 1-0. All other surgical procedures were standardized. | Procedure or surgery | Classical Continuous Fascial Closure |
Primary outcome
Postoperative pain intensity measured by Visual Analog Scale (VAS)
Time frame: 6, 12, 24, and 48 hours after cesarean section
Postoperative pain intensity is assessed using a 0-10 Visual Analog Scale (VAS), where higher scores indicate greater pain severity. Pain scores are recorded at 6, 12, 24, and 48 hours following surgery and compared between the classical continuous fascial closure group and the guide-suture-assisted modified fascial closure group.
4 secondary outcomes
Pain intensity during movement measured by Numeric Rating Scale (NRS)
Time frame: 6, 12, 24, and 48 hours after cesarean section
Pain quality measured by Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 6, 12, 24, and 48 hours after cesarean section
Functional recovery measured by walking distance
Time frame: 6, 12, 24, and 48 hours after cesarean section
Postoperative analgesic consumption
Time frame: Within 48 hours after cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to privacy and ethical restrictions. Data may be available from the corresponding author upon reasonable request and with appropriate ethical approval.
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical continuous fascial closure and Guide-suture-assisted modified fascial closure in people with Cesarean Section and Postoperative Pain, run by Necmettin Erbakan University 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity measured by Visual Analog Scale (VAS) (time frame: 6, 12, 24, and 48 hours after cesarean section). 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 27 Feb 2026.