Minimaly Ivnasive Surgery for Grade III Hemorrhoids
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Son Llatzer
About this trial
Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Closed excisional hemorrhoidectomy (CEH), based on the Ferguson technique, is one of the standard procedures. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies.
Since no previous studies on the application of MIS in CEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into closed excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Grade III/IV hemorrhoids
Indication for CEH surgery
Signed written informed consent
Disqualifiers
Acute hemorrhoidal disease (thrombosis)
Previous hemorrhoid surgery
Coexistence of anal fissure
Coexistence of perianal fistula
Trial population
Patients attending the Surgery Department of our Hospital
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Minimally Invasive hemorrhoidectomy
Procedure/SurgeryThe investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Grade III / IV hemorrhoids1 intervention
Trial outcomes
Primary outcomes
1
Technical Reproducibility of Surgery
ince no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications.
Time frame
30 postoperative daysSecondary outcomes
1
Adverse events in treated patients
Collect the adverse effects that occur during the operative period and within the first 30 postoperative days. Filter those attributable to the use of the minimally invasive approach. Analyze the causes and the technical steps that should be performed or omitted to avoid them. As measurement tools, the Clavien-Dindo scale and the Comprehensive Complication Index (CCI) will be used. The CCI is an index that uses the Clavien-Dindo scale and is calculated with a mathematical formula available at www.assessurgery.com
Time frame
30 postoperative days2
Postoperative pain
Postoperative pain will be evaluated using the Visual Analogue Scale (VAS), a validated tool ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will self-assess their baseline pain and pain following defecation at predefined intervals: postoperative days 4, 7, and 14.
Time frame
The first 14 postoperative days3
Hemorrhoidal disease symptom score
A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome.
Time frame
one postoperative year4
Short Health Scale in hemorrhoidal disease
A subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome
Time frame
One year postoperativeSponsors and contacts
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Source ClinicalTrials.gov