Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:49 AM
Study NCT ID:
NCT07436520
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Guide-Suture-Assisted Modified Fascial Closure on Postoperative Pain and Early Mobilization After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain intensity measured by Visual Analog Scale (VAS)', 'timeFrame': '6, 12, 24, and 48 hours after cesarean section', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity during movement measured by Numeric Rating Scale (NRS)', 'timeFrame': '6, 12, 24, and 48 hours after cesarean section', 'description': '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.'}, {'measure': 'Pain quality measured by Short-Form McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': '6, 12, 24, and 48 hours after cesarean section', 'description': 'Pain quality and intensity are evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ), which assesses sensory and affective components of pain.'}, {'measure': 'Functional recovery measured by walking distance', 'timeFrame': '6, 12, 24, and 48 hours after cesarean section', 'description': 'Functional recovery is assessed by measuring walking distance in meters at each postoperative time point. Greater walking distance indicates better functional recovery.'}, {'measure': 'Postoperative analgesic consumption', 'timeFrame': 'Within 48 hours after cesarean section', 'description': 'The type and frequency of analgesic medications administered during the first 48 hours after surgery are recorded and compared between study groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Section, Postoperative Pain,, Fascial Closure Surgical Technique, Early Mobilization, Obstetric Surgery, Pain Management'], 'conditions': ['Cesarean Section', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nCesarean 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.\n\nParticipants 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.\n\nThe study aims to determine whether this modified surgical technique improves postoperative comfort and facilitates earlier mobilization compared with the conventional technique.', 'detailedDescription': '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.\n\nEligible 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.\n\nAll 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.\n\nPostoperative 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.\n\nThe 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.\n\nThis study provides evidence regarding a simple surgical modification that may improve postoperative recovery following cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Women aged 18 to 35 years\n\nScheduled for elective cesarean section\n\nSingleton pregnancy\n\nGestational age ≥ 37 weeks\n\nAmerican Society of Anesthesiologists (ASA) physical status class I or II\n\nPlanned cesarean section with Pfannenstiel incision\n\nAbility to provide written informed consent\n\nExclusion Criteria:Emergency cesarean section\n\nHistory of previous cesarean section\n\nSevere intra-abdominal adhesions\n\nKnown coagulopathy or bleeding disorders\n\nActive infection\n\nIntraoperative complications\n\nInability or unwillingness to provide informed consent\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07436520', 'acronym': 'GSMF-CS', 'briefTitle': 'Effect of Guide-Suture-Assisted Modified Fascial Closure on Postoperative Pain and Early Mobilization After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025/6054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classical Continuous Fascial Closure', '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.', 'interventionNames': ['Procedure: Guide-suture-assisted modified fascial closure']}, {'type': 'EXPERIMENTAL', 'label': 'Guide-Suture-Assisted Modified Fascial Closure', '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).', 'interventionNames': ['Procedure: Classical continuous fascial closure']}], 'interventions': [{'name': 'Classical continuous fascial closure', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Guide-Suture-Assisted Modified Fascial Closure']}, {'name': 'Guide-suture-assisted modified fascial closure', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Classical Continuous Fascial Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42080', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University Meram Medical Faculty Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hasan Energin', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}