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

Necmettin Erbakan University

Status: Completed

Conditions: Postoperative Pain; Cesarean Section

Treatments: Procedure: Classical continuous fascial closure; Procedure: Guide-suture-assisted modified fascial closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07436520

2025/6054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Classical Continuous Fascial Closure

Active Comparator group

Description:

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.

Treatment:

Procedure: Guide-suture-assisted modified fascial closure

Guide-Suture-Assisted Modified Fascial Closure

Experimental group

Description:

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).

Treatment:

Procedure: Classical continuous fascial closure