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

NCT07436520 | Completed

• 1 other identifier: 2025/6054
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cesarean Section; Postoperative Pain

Keywords

Cesarean Section, Postoperative Pain,, Fascial Closure Surgical Technique, Early Mobilization, Obstetric Surgery, Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain intensity during movement measured by Numeric Rating Scale (NRS)

  6, 12, 24, and 48 hours after cesarean section

• Pain quality measured by Short-Form McGill Pain Questionnaire (SF-MPQ)

  6, 12, 24, and 48 hours after cesarean section

• Functional recovery measured by walking distance

  6, 12, 24, and 48 hours after cesarean section

• Postoperative analgesic consumption

  Within 48 hours after cesarean section

Study Arms (2)

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.

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).

Procedure: Classical continuous fascial closure

Interventions

Classical continuous fascial closure PROCEDURE

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 Closure

Guide-suture-assisted modified fascial closure PROCEDURE

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.

Classical Continuous Fascial Closure

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University Meram Medical Faculty Hospital

Konya, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial. Due to the nature of the surgical interventions, masking of participants, care providers, and investigators was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: October 25, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)