---
title: Minimaly Ivnasive Surgery for Grade III Hemorrhoids
nct_id: NCT07534761
overall_status: NOT_YET_RECRUITING
sponsor: Hospital Son Llatzer
study_type: OBSERVATIONAL
primary_condition: Hemorrhoidectomy
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07534761.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07534761"
ct_last_update_post_date: 2026-04-21
last_seen_at: "2026-05-12T06:17:20.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Minimaly Ivnasive Surgery for Grade III Hemorrhoids

**Official Title:** Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework

**NCT ID:** [NCT07534761](https://clinicaltrials.gov/study/NCT07534761)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Hospital Son Llatzer
- **Conditions:** Hemorrhoidectomy, Minimally Invasive Surgical Technique
- **Start Date:** 2026-06-01
- **Completion Date:** 2027-12-01
- **CT.gov Last Update:** 2026-04-21

## Brief Summary

Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Closed excisional hemorrhoidectomy (CEH), based on the Ferguson technique, is one of the standard procedures. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies.

Since no previous studies on the application of MIS in CEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into closed excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age over 18 years
* Grade III/IV hemorrhoids
* Indication for CEH surgery
* Signed written informed consent

Exclusion Criteria:

* Acute hemorrhoidal disease (thrombosis)
* Previous hemorrhoid surgery
* Coexistence of anal fissure
* Coexistence of perianal fistula
* Coexistence of rectal or anal prolapse
* Active inflammatory bowel disease
* Active anal or colorectal cancer
* Language barrier or difficulty in oral and/or written comprehension
```

## Arms

- **Grade III / IV hemorrhoids** — Patients with symptomatic grade III/IV hemorrhoids who consent to surgical intervention

## Interventions

- **Minimally Invasive hemorrhoidectomy** (PROCEDURE) — The investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

## Primary Outcomes

- **Technical Reproducibility of Surgery** _(time frame: 30 postoperative days)_ — ince no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications.

## Secondary Outcomes

- **Adverse events in treated patients** _(time frame: 30 postoperative days)_
- **Postoperative pain** _(time frame: The first 14 postoperative days)_
- **Hemorrhoidal disease symptom score** _(time frame: one postoperative year)_
- **Short Health Scale in hemorrhoidal disease** _(time frame: One year postoperative)_
- **Total number of postoperative analgesics** _(time frame: 14 postoperative days)_
- **Clinical Failure Rate** _(time frame: one year postoperative)_

## Locations (1)

- Hospital Son Llatzer, Palma, Balearic Islands, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital son llatzer|palma|balearic islands|spain` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07534761*  
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