Effect of Guide-Suture-Assisted Modified Fascial Closure on Postoperative Pain and Early Mobilization After Cesarean Section (GSMF-CS)

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.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cesarean Section
• Intervention / Treatment: Procedure: Guide-suture-assisted modified fascial closure; Procedure: Classical continuous fascial closure

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye), 42080
    • Necmettin Erbakan University Meram Medical Faculty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Women aged 18 to 35 years

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

Exclusion Criteria:Emergency cesarean section

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

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Classical Continuous Fascial Closure; 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.	Procedure: Guide-suture-assisted modified fascial closure; 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.
Experimental: Guide-Suture-Assisted Modified Fascial Closure; 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).	Procedure: Classical continuous fascial closure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6, 12, 24, and 48 hours after cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Within 48 hours after cesarean section

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cesarean Section, Postoperative Pain,, Fascial Closure Surgical Technique, Early Mobilization, Obstetric Surgery, Pain Management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia
• Other Study ID Numbers: 2025/6054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No