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NCT Number: NCT06535269

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laura Mora López

Sabadell, Barcelona, 08208, Spain

Location status: Recruiting

Location contact

Laura Mora, Dr.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monopolar Hemorroidecotmy

Procedure

Hemorrhoidectomy with monopolar diathermy

Caiman Hemorroidectomy

Procedure

Hemorrhoidectomy with Caiman® bipolar energy

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Wound healing time

    Time frame: 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

  2. Post-surgery satisfaction survey

    Time frame: 30 days postoperative control at external consultations

    Phone checklist survey

  3. Wexner scale

    Time frame: 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.

  4. Number of emergency consultations

    Time frame: in 30 days post-surgery

    revision of Database

  5. Collection of adverse effects from patients

    Time frame: in 30 days post-surgery

    revision of Database

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Mora

CONTACT

[email protected]

34 937211010 ext. 21490

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study 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®)

Acronym: TAUHEMOR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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