Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-21 @ 8:06 PM
Study NCT ID:
NCT06841432
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2025-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coblation Versus Suction Diathermy in Pediatric Adenoidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-20', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative duration', 'timeFrame': 'During the procedure', 'description': 'The procedure, from the initial insertion of the Bowel-Davis mouth gag to the complete removal of the adenoid and the gag, was timed in minutes.'}, {'measure': 'Intraopertive blood loss', 'timeFrame': 'during the procedures', 'description': 'Boezaart surgical field grading scale was used to evaluate the intraoperative bleeding'}, {'measure': 'Postopertaive Pain', 'timeFrame': 'Patients reported their pain levels every day before taking any pain medication during the 7 days after their surgery', 'description': 'The Wong-Baker Pain Scale consists of 6 faces depicting different levels of pain. Face 1 represents no pain, Face 2 indicates a little bit of hurt, Face 3 indicates a little more hurt, Face 4 indicates even more hurt, Face 5 indicates a whole lot of hurt, and Face 6 indicates the worst possible hurt, with pain scores ranging from 0 to 10. Both the children and their parents were informed about the purpose of the questionnaires and how to fill them out before the surgery'}], 'secondaryOutcomes': [{'measure': 'Development of bad breath', 'timeFrame': 'from the end of operation till 2 weeks post operation', 'description': 'frequency of Children who presented with bad breath'}, {'measure': 'recovery time', 'timeFrame': 'three months post opertaive', 'description': 'time which was talken for the patients to resume their normal social routines'}, {'measure': 'secondary bleeding', 'timeFrame': 'up to one month surgery', 'description': 'frequency of Children who presented with bleeding that occurred after 24 hrs of operation'}, {'measure': 'Pre- and post-adenoid size grading', 'timeFrame': 'preintervention (one day before opertaion ) and postintervention (up to three months)', 'description': 'The Parikh grading system (1-4) is used to assess the extent of adenoid tissue contact with surrounding structures: Grade 1 - adenoid tissue not in contact, Grade 2 - adenoid tissue in contact with Eustachian tube cushions, Grade 3 - adenoid tissue in contact with vomer, Grade 4 - adenoid tissue in contact with soft palate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic', 'Adenoidectomy', 'adenoid hypertrophy', 'Pediatric', 'Suction Diathermy', 'Coblation'], 'conditions': ['Adenoid Hypertrophy', 'Adenoidectomy', 'Coblation Adenoidectomy', 'Suction Daithermy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare two surgical procedures in endoscopic adenoidectomy including Coblation and Suction diathermy\n\n. The main questions it aims to answer are: Does the Coblation device have less time, less pain, less postoperative crustation and bad odor, less intraoperative bleeding, and less recurrence?\n\nParticipants will:\n\nwill undergo both procedures every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* all patients aged 2 to 18 years\n* patients who had isolated adenoid hypertrophy\n* patients' hemoglobin levels above 10 mg/dl\n\nExclusion Criteria:\n\n* those with recent upper respiratory tract infections, evidence of bleeding disorders, serous otitis media, chronic tonsillitis\n* those advised against undergoing adenoidectomy after consulting a phoniatrist\n* patients with atrophic rhinitis those with nasal obstruction caused by other nasal or paranasal conditions such as inferior turbinate hypertrophy, Choanal atresia, deviated nasal septum, antrochoanal polyps, and other causes of nasal obstruction in children."}, 'identificationModule': {'nctId': 'NCT06841432', 'briefTitle': 'Coblation Versus Suction Diathermy in Pediatric Adenoidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Endoscopic Coblation Versus Suction Diathermy in Pediatric Adenoidectomy: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MSCAZASTENT03028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients who underwent the adenoidectomy using suction diathermy', 'description': 'One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine.', 'interventionNames': ['Procedure: adenoidectomy by Suction diathermy']}, {'type': 'EXPERIMENTAL', 'label': 'patients who underwent the adenoidectomy using coblation', 'description': "One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATOR™ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes.", 'interventionNames': ['Procedure: adenoidectomy using coblatioion']}], 'interventions': [{'name': 'adenoidectomy using coblatioion', 'type': 'PROCEDURE', 'description': "One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATOR™ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes.", 'armGroupLabels': ['patients who underwent the adenoidectomy using coblation']}, {'name': 'adenoidectomy by Suction diathermy', 'type': 'PROCEDURE', 'description': 'One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine.', 'armGroupLabels': ['patients who underwent the adenoidectomy using suction diathermy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Alazhar university Hopital in Assiut', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor of otorhinolanrgology at alazhar univeristy hopsital in assiut', 'investigatorFullName': 'Ahmed Nabil Selim', 'investigatorAffiliation': 'Al-Azhar University'}}}}