Phlebotonics for haemorrhoids.
Nirmal Perera, Danae Liolitsa, Satheesh Iype...
https://pubmed.ncbi.nlm.nih.gov/22895941Actively Recruiting
Led by Corporacion Parc Tauli · Updated on 2024-08-02
27
Participants Needed
1
Research Sites
25 weeks
Total Duration
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
Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Laura Mora López
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
L
Laura Mora
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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