Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 8:26 PM
Study NCT ID:
NCT06535269
Status:
RECRUITING
Last Update Posted:
2024-08-02
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': '6 hours of post-operative period (before hospital discharge performed); within 2 days with telephone control; at 7 days control at external consultations; at 30 days control at external consultations', 'description': 'Postoperative pain: value 0 (no pain) - 10 (maximum pain)'}], 'secondaryOutcomes': [{'measure': 'Wound healing time', 'timeFrame': '7 days postoperative control at external consultations; 30 days postoperative control at external consultations', 'description': 'A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized'}, {'measure': 'Post-surgery satisfaction survey', 'timeFrame': '30 days postoperative control at external consultations', 'description': 'Phone checklist survey'}, {'measure': 'Wexner scale', 'timeFrame': 'in pre-operative visit, on the 7th and 30th postoperative clinical control', 'description': 'Assessment of fecal incontinence o a scale from 0 (never incontinence) to 4 (always), obtaining a score between 0 and 20.'}, {'measure': 'Number of emergency consultations', 'timeFrame': 'in 30 days post-surgery', 'description': 'revision of Database'}, {'measure': 'Collection of adverse effects from patients', 'timeFrame': 'in 30 days post-surgery', 'description': 'revision of Database'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoid Pain', 'Hemorrhoidectomy']}, 'referencesModule': {'references': [{'pmid': '22895941', 'type': 'BACKGROUND', 'citation': 'Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3.'}, {'pmid': '16235372', 'type': 'BACKGROUND', 'citation': 'Alonso-Coello P, Guyatt G, Heels-Ansdell D, Johanson JF, Lopez-Yarto M, Mills E, Zhou Q. Laxatives for the treatment of hemorrhoids. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD004649. doi: 10.1002/14651858.CD004649.pub2.'}, {'pmid': '16034963', 'type': 'BACKGROUND', 'citation': 'Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD005034. doi: 10.1002/14651858.CD005034.pub2.'}, {'pmid': '27960130', 'type': 'BACKGROUND', 'citation': 'Medina-Gallardo A, Curbelo-Pena Y, De Castro X, Roura-Poch P, Roca-Closa J, De Caralt-Mestres E. Is the severe pain after Milligan-Morgan hemorrhoidectomy still currently remaining a major postoperative problem despite being one of the oldest surgical techniques described? A case series of 117 consecutive patients. Int J Surg Case Rep. 2017;30:73-75. doi: 10.1016/j.ijscr.2016.11.018. Epub 2016 Nov 15.'}, {'pmid': '19160300', 'type': 'BACKGROUND', 'citation': 'Nienhuijs S, de Hingh I. Conventional versus LigaSure hemorrhoidectomy for patients with symptomatic Hemorrhoids. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006761. doi: 10.1002/14651858.CD006761.pub2.'}, {'pmid': '21991510', 'type': 'BACKGROUND', 'citation': 'Gentile M, De Rosa M, Carbone G, Pilone V, Mosella F, Forestieri P. LigaSure Haemorrhoidectomy versus Conventional Diathermy for IV-Degree Haemorrhoids: Is It the Treatment of Choice? A Randomized, Clinical Trial. ISRN Gastroenterol. 2011;2011:467258. doi: 10.5402/2011/467258. Epub 2010 Nov 21.'}, {'pmid': '24141714', 'type': 'BACKGROUND', 'citation': 'World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.'}, {'pmid': '27440100', 'type': 'BACKGROUND', 'citation': 'Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.', 'detailedDescription': 'In the treatment of coloproctological pathology, one of the most important problems is postoperative pain. Especially in the management of hemorrhoids treatment. There are different approaches but in all of them pain is the predominant symptom.\n\nThere are some less painful techniques but the gold standard continues to be hemmorrhoidectomy, which is associated with postoperative pain. Some actions have been taken to control pain to avoid the admission of patients, but there are still problems in this regard.\n\nOur group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy\n* Voluntary participation.\n* ASA I-II-III.\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria.\n* ASA IV.\n* Allergic to Paracetamol, derivatives of morphine.\n* Allergic to NSAIDs.\n* Synchronous colorectal neoplasia.\n* Coagulation disorders.\n* Thrombosed hemorrhoid.\n* Inflammatory bowel disease.\n* Liver cirrhosis and/or portal hypertension.\n* Pregnant women.\n* Difficulty following up by phone and/or in person.'}, 'identificationModule': {'nctId': 'NCT06535269', 'acronym': 'TAUHEMOR', 'briefTitle': 'Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Prospective Randomized Study on Postoperative Pain in the Surgical Treatment of Hemorrhoids Through Conventional Hemorrhoidectomy With a Monopolar Electric Scalpel or Bipolar Energy With Caiman® (Aesculap®)', 'orgStudyIdInfo': {'id': 'TAUHEMOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization.', 'interventionNames': ['Procedure: Monopolar Hemorroidecotmy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'conventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge.', 'interventionNames': ['Procedure: Caiman Hemorroidectomy']}], 'interventions': [{'name': 'Monopolar Hemorroidecotmy', 'type': 'PROCEDURE', 'description': 'Hemorrhoidectomy with monopolar diathermy', 'armGroupLabels': ['Control']}, {'name': 'Caiman Hemorroidectomy', 'type': 'PROCEDURE', 'description': 'Hemorrhoidectomy with Caiman® bipolar energy', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura Mora, Dr.', 'role': 'CONTACT', 'email': 'mora.lopez.laura@gmail.com'}], 'facility': 'Laura Mora López', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Laura Mora', 'role': 'CONTACT', 'email': 'mora.lopez.laura@gmail.com', 'phone': '34 937211010', 'phoneExt': '21490'}], 'overallOfficials': [{'name': 'Laura Mora', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parc Tauli University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MD, Colorrectal Surgeon, Associate Professor', 'investigatorFullName': 'Laura Mora-Lopez', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}