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

Corporacion Parc Tauli

Status: Enrolling

Conditions: Hemorrhoidectomy; Hemorrhoid Pain

Treatments: Procedure: Caiman Hemorroidectomy; Procedure: Monopolar Hemorroidecotmy

Study type: Interventional

Funder types: Other

Identifiers

NCT06535269

TAUHEMOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Procedure: Monopolar Hemorroidecotmy

Experimental

Experimental group

Description:

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

Treatment:

Procedure: Caiman Hemorroidectomy