Hemorrhoidectomy, Hemorrhoid Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMonopolar Hemorroidecotmy
Hemorrhoidectomy with monopolar diathermy
PROCEDURECaiman Hemorroidectomy
Hemorrhoidectomy with Caiman® bipolar energy
Sponsors
Corporacion Parc Tauli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Wexner scale | 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. |
| Number of emergency consultations | in 30 days post-surgery | revision of Database |
| Wound healing time | 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 |
| Post-surgery satisfaction survey | 30 days postoperative control at external consultations | Phone checklist survey |
| Collection of adverse effects from patients | in 30 days post-surgery | revision of Database |
Countries
Spain
Contacts
Primary ContactLaura Mora
Outcome results
None listed