## Protocol Section
### Identification Module
**NCT ID:** NCT06420986

**Brief Title:** Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms

**Official Title:** Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial

#### Organization Study ID Info
**ID:** IB4323-20PI
#### Organization
**Class:** OTHER
**Full Name:** Hospital Son Llatzer
### Status Module
#### Completion Date
**Date:** 2024-04-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-17

**Type:** ACTUAL

#### Start Date
**Date:** 2021-08-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Fundació d'investigació Sanitària de les Illes Balears

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Son Llatzer

#### Responsible Party

**Investigator Affiliation:** Hospital Son Llatzer

**Investigator Full Name:** Ignacio Fernandez Hurtado

**Investigator Title:** Specialist in General Surgery. Specialist in Digestive Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is:

- Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD?

Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure.

Participants will:

* Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD.
* Fill in symptom forms before and one year after the surgical procedure.
* Attend control visits one week, one month, three months and one year after the surgical procedure.

### Conditions Module

**Conditions:**

- Hemorrhoids Third Degree

**Keywords:**

- hemorrhoids third degree

- botulinum Toxin

- Hemorrhoidectomy

- Transanal Hemorrhoidal Dearterialization

- hemorrhoidal Disease Symptom Score

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Open Hemorrhoidectomy

**Label:** Hemorrhoidectomy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Transanal Hemorrhoidal Dearterialization

**Label:** Transanal Hemorrhoidal Dearterialization

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hemorrhoidectomy

**Description:** Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan

**Name:** Open Hemorrhoidectomy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Transanal Hemorrhoidal Dearterialization

**Description:** Surgical treatment of Hemorrhoids. This operation involves no excision. The hemorrhoidal arteries are ligated and the hemorrhoial prolapse is treated by a suture mucopexi. Described by Rato

**Name:** Transanal Hemorrhoidal Dearterialization

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome

**Measure:** hemorrhoidal disease symptom score

**Time Frame:** one year

**Description:** a subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome

**Measure:** short health scale in hemorrhoidal disease

**Time Frame:** one year

#### Secondary Outcomes

**Description:** pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome

**Measure:** postoperative pain

**Time Frame:** 1 week after surgical procedure

**Description:** measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome

**Measure:** fecal incontinence

**Time Frame:** baseline and 1 week, 3 months and 1 year after surgical procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* Age older than 18.
* Hemorroids grade III.
* Surgical indication for hemorroid treatment.
* Signed informed consent.

Exclusion criteria:

* Acute hemorroidal disease.
* Previous hemorroidal surgery.
* Concomitant anal fissure.
* Concomitant perianal fistulae.
* Concomitant rectal prolapse.
* Inflamatory bowel disease.
* Anal or colorrectal cancer.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Palma De Mallorca

**Country:** Spain

**Facility:** Hospital Son Llatzer

**State:** Illes Balears

**Zip:** 07198

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012002

- Term: Rectal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9570

- Name: Hemorrhoids

- Relevance: HIGH

- As Found: Hemorrhoids

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006484

- Term: Hemorrhoids

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5183

- Name: Botulinum Toxins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
