Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)

Official title

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®)

Overview

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.

Detailed description

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.

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.

Interventions

• Procedure Monopolar Hemorroidecotmy
  Hemorrhoidectomy with monopolar diathermy
• Procedure Caiman Hemorroidectomy
  Hemorrhoidectomy with Caiman® bipolar energy

Primary outcome measures

• Visual analogue scale (VAS) [Time frame: 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]

Secondary outcome measures (5)

• Wound healing time [Time frame: 7 days postoperative control at external consultations; 30 days postoperative control at external consultations]
• Post-surgery satisfaction survey [Time frame: 30 days postoperative control at external consultations]
• Wexner scale [Time frame: in pre-operative visit, on the 7th and 30th postoperative clinical control]
• Number of emergency consultations [Time frame: in 30 days post-surgery]
• Collection of adverse effects from patients [Time frame: in 30 days post-surgery]

Eligibility criteria

Inclusion criteria

• All patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy
• Voluntary participation.
• ASA I-II-III.

Exclusion criteria

• Failure to meet the inclusion criteria.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Laura Mora López — Sabadell

Publications

• 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 22895941
• 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 16235372
• 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 16034963
• 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 PMID 27960130
• 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 19160300
• 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 21991510
• 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 24141714
• 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. PMID 27440100

Identifiers

NCT: NCT06535269 · TAUHEMOR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗