An interventional study of Monopolar Hemorroidecotmy and Caiman Hemorroidectomy in Hemorrhoid Pain and Hemorrhoidectomy, sponsored by Corporacion Parc Tauli. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 27 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Corporacion Parc Tauli is the lead sponsor of 167 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization.
Procedure: Monopolar Hemorroidecotmy
conventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge.
Procedure: Caiman Hemorroidectomy
Hemorrhoidectomy with monopolar diathermy
Hemorrhoidectomy with Caiman® bipolar energy
Visual analogue scale (VAS)
Postoperative pain: value 0 (no pain) - 10 (maximum pain)
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
Wound healing time
A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized
Time frame: 7 days postoperative control at external consultations; 30 days postoperative control at external consultations
Post-surgery satisfaction survey
Phone checklist survey
Time frame: 30 days postoperative control at external consultations
Wexner scale
Assessment of fecal incontinence o a scale from 0 (never incontinence) to 4 (always), obtaining a score between 0 and 20.
Time frame: in pre-operative visit, on the 7th and 30th postoperative clinical control
Number of emergency consultations
revision of Database
Time frame: in 30 days post-surgery
Collection of adverse effects from patients
revision of Database
Time frame: in 30 days post-surgery
Plan to share: No
Started Nov 2022 (actual). Primary completion is estimated for Jan 2025, 26 months after the start.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 26 months is above that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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