Clinical trial NCT06535269: Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)
Official title: 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®)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhoid Pain
Hemorrhoidectomy
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 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
Secondary outcomes:
measure: Wound healing time
timeFrame: 7 days postoperative control at external consultations; 30 days postoperative control at external consultations
measure: Post-surgery satisfaction survey
timeFrame: 30 days postoperative control at external consultations
measure: Wexner scale
timeFrame: in pre-operative visit, on the 7th and 30th postoperative clinical control
measure: Number of emergency consultations
timeFrame: in 30 days post-surgery
measure: Collection of adverse effects from patients
timeFrame: in 30 days post-surgery
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Laura Mora López
state: Barcelona
Study officials:
affiliation: Parc Tauli University Hospital
name: Laura Mora
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3.
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citation: Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD005034. doi: 10.1002/14651858.CD005034.pub2.
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