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

ConditionsHemorrhoid PainHemorrhoidectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCorporacion Parc Tauli

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Failure to meet the inclusion criteria.

ASA IV.

Allergic to Paracetamol, derivatives of morphine.

Allergic to NSAIDs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Monopolar Hemorroidecotmy

    Procedure/Surgery

    Hemorrhoidectomy with monopolar diathermy

  • Caiman Hemorroidectomy

    Procedure/Surgery

    Hemorrhoidectomy with Caiman® bipolar energy

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual analogue scale (VAS)

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

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 outcomes

1

Wound healing time

A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized

Time frame
7 days postoperative control at external consultations; 30 days postoperative control at external consultations
2

Post-surgery satisfaction survey

Phone checklist survey

Time frame
30 days postoperative control at external consultations
3

Wexner scale

Assessment of fecal incontinence o a scale from 0 (never incontinence) to 4 (always), obtaining a score between 0 and 20.

Time frame
in pre-operative visit, on the 7th and 30th postoperative clinical control
4

Number of emergency consultations

revision of Database

Time frame
in 30 days post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corporacion Parc Tauli

Lead sponsor

Source ClinicalTrials.gov
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