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

NCT06535269 | Recruiting DMC

• 1 other identifier: TAUHEMOR
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoid Pain; Hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)

  Postoperative pain: value 0 (no pain) - 10 (maximum pain)

  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 Outcomes (5)

• Wound healing time

  7 days postoperative control at external consultations; 30 days postoperative control at external consultations

• Post-surgery satisfaction survey

  30 days postoperative control at external consultations

• Wexner scale

  in pre-operative visit, on the 7th and 30th postoperative clinical control

• Number of emergency consultations

  in 30 days post-surgery

• Collection of adverse effects from patients

  in 30 days post-surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization.

Procedure: Monopolar Hemorroidecotmy

Experimental

EXPERIMENTAL

conventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge.

Procedure: Caiman Hemorroidectomy

Interventions

Monopolar Hemorroidecotmy PROCEDURE

Hemorrhoidectomy with monopolar diathermy

Control

Caiman Hemorroidectomy PROCEDURE

Hemorrhoidectomy with Caiman® bipolar energy

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Laura Mora López

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 27960130 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Laura Mora

  Parc Tauli University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Mora

CONTACT

34 937211010; mora.lopez.laura@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Colorrectal Surgeon, Associate Professor

Model Details: Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 2, 2024
• Study Start: November 2, 2022
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)