Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)
NCT ID: NCT06535269
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
27 participants
INTERVENTIONAL
2022-11-02
2025-07-31
Brief Summary
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Detailed Description
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There 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.
Our group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization.
Monopolar Hemorroidecotmy
Hemorrhoidectomy with monopolar diathermy
Experimental
conventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge.
Caiman Hemorroidectomy
Hemorrhoidectomy with Caiman® bipolar energy
Interventions
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Monopolar Hemorroidecotmy
Hemorrhoidectomy with monopolar diathermy
Caiman Hemorroidectomy
Hemorrhoidectomy with Caiman® bipolar energy
Eligibility Criteria
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Inclusion Criteria
* Voluntary participation.
* ASA I-II-III.
* ASA IV.
* Allergic to Paracetamol, derivatives of morphine.
* Allergic to NSAIDs.
* Synchronous colorectal neoplasia.
* Coagulation disorders.
* Thrombosed hemorrhoid.
* Inflammatory bowel disease.
* Liver cirrhosis and/or portal hypertension.
* Pregnant women.
* Difficulty following up by phone and/or in person.
18 Years
65 Years
ALL
Yes
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Laura Mora-Lopez
PhD, MD, Colorrectal Surgeon, Associate Professor
Principal Investigators
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Laura Mora
Role: PRINCIPAL_INVESTIGATOR
Parc Tauli University Hospital
Locations
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Laura Mora López
Sabadell, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TAUHEMOR
Identifier Type: -
Identifier Source: org_study_id
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