Comparing pain after two types of hemorrhoid surgery
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®)
This study is testing if a new type of hemorrhoid surgery using a special device causes less pain and helps patients recover better than the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Corporacion Parc Tauli Academic / other |
| Locations | 1 site (Sabadell, Barcelona) |
| Trial ID | NCT06535269 on ClinicalTrials.gov |
What this trial studies
This study aims to compare postoperative pain levels in patients undergoing hemorrhoidectomy using two different techniques: monopolar diathermy and a bipolar energy device called Caiman®. The goal is to determine if the bipolar method results in less pain and better recovery outcomes compared to the conventional approach. Patients will be monitored for pain levels and analgesic requirements following their outpatient procedures. The study focuses on symptomatic patients with grade III-IV hemorrhoids.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic grade III-IV hemorrhoids who are eligible for outpatient hemorrhoidectomy.
Not a fit: Patients with severe comorbidities or specific contraindications, such as ASA IV classification or certain allergies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing hemorrhoid surgery.
How similar studies have performed: Previous studies have explored various techniques for hemorrhoidectomy, but this specific comparison of monopolar versus bipolar energy is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sabadell, Barcelona
- Laura Mora López — Sabadell, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Laura Mora — Parc Tauli University Hospital
- Study coordinator: Laura Mora
- Email: mora.lopez.laura@gmail.com
- Phone: 34 937211010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.