Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

NCT06851312 | Completed

• 1 other identifier: HEM IDEAL1
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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. Open excisional hemorrhoidectomy (OEH), based on the Milligan-Morgan technique, is the standard procedure. 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. In Stage 1, the first application in humans is documented, analyzing outcomes and feasibility. Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 1 of the IDEAL model to assess the feasibility of this technique. The investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

Conditions

Hemorrhoidectomy; Minimal Invasive Surgery

Keywords

hemorrhoids grade III-IV; Hemorrhoidectomy; Minimal Invasive Surgery; IDEAl Stage 1

Outcome Measures

Primary Outcomes (1)

• Technical Feasibility of Surgery

  Since no studies using this approach were found in the literature, the investigators propose a study to assess the feasibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 1. The measurement tool will be the number of patients in whom the technique could be performed

  From enrollment to the surgical procedure

Study Arms (1)

Grade III Hemorrhoids

Patients with symptomatic grade III hemorrhoids who consent to surgical intervention

Procedure: Minimal invasive hemorrhoidectomy

Interventions

Minimal invasive hemorrhoidectomy PROCEDURE

We propose applying minimally invasive surgery in open excisional hemorrhoidectomy, the most effective technique for treating advanced hemorrhoidal disease. We believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of OEH. Our hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

Grade III Hemorrhoids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Surgery Department of our Hospital

You may qualify if:

• Age over 18 years
• Grade III hemorrhoids
• BMI below 30
• Indication for OEH surgery
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Study Sites (1)

Hospital Son Llatzer

Palma, 07190, Spain

Location

Related Publications (2)

• Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794.

  PMID: 29697448 BACKGROUND

• McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.

  PMID: 19782876 BACKGROUND

Study Officials

• Ignacio Fernandez Hurtado, Colorectal Surgeon

  Hospital Son Llatzer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

ES (1)