NCT07436520

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-10-25
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)