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NCT Number: NCT07436520

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University Meram Medical Faculty Hospital

Konya, 42080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 6, 12, 24, and 48 hours after cesarean section

    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.

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

    Time frame: 6, 12, 24, and 48 hours after cesarean section

    Pain quality and intensity are evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ), which assesses sensory and affective components of pain.

  3. Functional recovery measured by walking distance

    Time frame: 6, 12, 24, and 48 hours after cesarean section

    Functional recovery is assessed by measuring walking distance in meters at each postoperative time point. Greater walking distance indicates better functional recovery.

  4. Postoperative analgesic consumption

    Time frame: Within 48 hours after cesarean section

    The type and frequency of analgesic medications administered during the first 48 hours after surgery are recorded and compared between study groups.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study 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

Acronym: GSMF-CS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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