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

Not Applicable

Recruiting

• Conditions: Hemorrhoidectomy; Hemorrhoid Pain
• Interventions: Procedure: Caiman Hemorroidectomy; Procedure: Monopolar Hemorroidecotmy

• Registration Number: NCT06535269
• Lead Sponsor: Corporacion Parc Tauli

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.

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.

Study Timeline

• Study Start: 2022-11-02
• Study First Submitted: 2024-07-11
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-01
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Caiman Hemorroidectomy	conventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge.
Control	Monopolar Hemorroidecotmy	Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	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	Postoperative pain: value 0 (no pain) - 10 (maximum pain)

Secondary Outcome Measures

Name	Time	Method
Wound healing time	7 days postoperative control at external consultations; 30 days postoperative control at external consultations	A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized
Post-surgery satisfaction survey	30 days postoperative control at external consultations	Phone checklist survey
Wexner scale	in pre-operative visit, on the 7th and 30th postoperative clinical control	Assessment of fecal incontinence o a scale from 0 (never incontinence) to 4 (always), obtaining a score between 0 and 20.
Number of emergency consultations	in 30 days post-surgery	revision of Database
Collection of adverse effects from patients	in 30 days post-surgery	revision of Database

Trial Locations

Locations (1)

Laura Mora López; 🇪🇸 Sabadell, Barcelona, Spain