Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06535269

Prospective Randomized Study Comparing Postoperative Pain After Conventional Hemorrhoidectomy With Monopolar Electric Scalpel Versus Bipolar Energy Using Caiman4 (Aesculap4)

Led by Corporacion Parc Tauli · Updated on 2024-08-02

27

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating postoperative pain following two surgical methods for treating hemorrhoids: the conventional hemorrhoidectomy using a monopolar electric scalpel with intravenous analgesia, and hemorrhoidectomy using bipolar energy with the Caiman4 device combined with oral conventional analgesia. The study focuses on patients with clinically symptomatic grade III-IV hemorrhoids and aims to determine if the pain after using the Caiman4 device and oral analgesia is at least not greater than the pain experienced after the conventional method with intravenous analgesia. Participants will be randomly assigned to one of two groups: one undergoing conventional hemorrhoidectomy with monopolar diathermy plus intravenous analgesia delivered via an elastomeric pump and discharged with home hospitalization care; the other will receive hemorrhoidectomy using Caiman4 bipolar energy followed by oral conventional pain medication and standard home discharge. The study involves outpatient procedures with follow-up controls at specific intervals. During the study, participants will be monitored for pain levels using a visual analogue scale at 6 hours post-operation, within 2 days via telephone, and at 7 and 30 days during outpatient visits. Additional assessments include wound healing time, patient satisfaction, evaluation using the Wexner scale, tracking of emergency consultations, and collection of any adverse effects up to 30 days post-surgery. The total participation involves multiple follow-up contacts to assess recovery and pain management effectiveness.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) who are clinically symptomatic and scheduled for outpatient hemorrhoidectomy
  • Voluntary participation in the study
  • ASA physical status classification I, II, or III
Not Eligible

You will not qualify if you...

  • Failure to meet inclusion criteria
  • ASA physical status classification IV
  • Allergy to paracetamol or morphine derivatives
  • Allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Presence of synchronous colorectal neoplasia
  • Coagulation disorders
  • Thrombosed hemorrhoid
  • Inflammatory bowel disease
  • Liver cirrhosis and/or portal hypertension
  • Pregnancy
  • Difficulty in following up by phone or in person

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 days

Participants undergo hemorrhoidectomy using either monopolar electric scalpel or bipolar energy (Caiman®). Postoperative pain is managed with analgesia and participants are discharged with home hospitalization or conventional home discharge depending on the treatment group.

Hospital stay including surgery and immediate post-operative period

Post-operative Follow-up

Duration - 30 days

Participants are followed up to assess pain levels, wound healing, satisfaction, and any adverse effects after surgery.

1 telephone visit within 2 days post-surgery; 3 in-person visits at 7 and 30 days post-surgery

Trial Site Locations

Total: 1 location

1

Laura Mora López

Sabadell, Barcelona, Spain, 08208

Actively Recruiting

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Research Team

L

Laura Mora

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Adrian Medina-Gallardo, Yuhamy Curbelo-Peña, Xavier De Castro...

https://pubmed.ncbi.nlm.nih.gov/27960130

LigaSure Haemorrhoidectomy versus Conventional Diathermy for IV-Degree Haemorrhoids: Is It the Treatment of Choice? A Randomized, Clinical Trial.

Maurizio Gentile, Michele De Rosa, Gabriele Carbone...

https://pubmed.ncbi.nlm.nih.gov/21991510