Clinical trial NCT06764849: Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial
Official title: Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoidectomy
Hemorrhoids Third Degree
Hemorrhoidal Disease
Postoperative Pain
Keywords: hemorrhoidal disease
minimally invasive open excisional hemorrhoidectomy
open excisional hemorrhoidectomy
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to demonstrate that open excisional hemorrhoidectomy (OEH), when performed using a minimally invasive approach, results in less postoperative pain and comparable outcomes to conventional OEH.

Detailed description: At our hospital, the investigators have developed a new approach to hemorrhoid surgery by modifying the traditional open excisional hemorrhoidectomy. This new method incorporates an image-amplifying device and utilizes microsurgery tools. Preliminary results have shown significant improvement in patients' immediate postoperative pain, with efficacy comparable to conventional methods one year after treatment.

We propose conducting a clinical trial to confirm these initial findings. The study will include two gropus: one undergoing conventional open excisional hemorrhoidectomy (OEH) and the other receiving minimally invasive open excisional hemorrhoidectomy (miOEH). Patients will be randomly assigned to one of these two groups.

The primary outcome of interest will be the level of postoperative pain assessed 10 days after surgery. The secondary outcomes will evaluate the effectiveness of the technique one year post-surgery, measured by the Hemorrhoidal Disease Symptom Score(HDSS) and the Short Health Scale in Hemorrhoidal Disease (SHSHD).

Eligibility criteria: Inclusion Criteria:

* Age older than 18 years.
* Hemorrhoids grade III.
* Surgical indication for hemorrhoidal disease.

Exclusion Criteria:

* Acute hemorrhoidal disease.
* Previous hemorrhoidal surgery.
* Concomitant anal fissure.
* Concomitant anal fistulae.
* Concomitant rectal prolapse.
* Concomitant inflamatory bowel disease or anal cancer.
* Language impairment.

Primary outcomes:
measure: Postoperative pain measured with the visual analogic scale
timeFrame: 10 days
measure: Postoperative pain measured by the number of rescue painkillers needed
timeFrame: 10 days
Secondary outcomes:
measure: Efficacy of the treatment using the Hemorrhoidal Disease Symptom Score
timeFrame: 1 year
measure: Efficacy of treatment using the Short Health Scale adapted for hemorrhoidal disease
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.