Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy: Study Protocol for a Single-center, Prospective, Open-label and Randomized Clinical Trial.

The Affiliated Hospital of Putian University

Status: Not yet enrolling

Conditions: Hemorrhoids

Treatments: Procedure: Closed Hemorrhoidectomy (Ferguson Technique); Procedure: Semi-Closed Hemorrhoidectomy; Procedure: Open Hemorrhoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07196865

AHPutianU 2025918

Details and patient eligibility

About

This study compares three different ways surgeons close the wound after removing hemorrhoids (piles): leaving it completely open, stitching it completely closed, or stitching only half of it closed (semi-closed). The goal is to see which method leads to faster healing, less pain, fewer complications, and better long-term results. Patients undergoing hemorrhoidectomy will be randomly assigned to one of the three groups. All patients will receive standard post-operative care. Researchers will measure healing time, pain levels, need for pain medication, hospital stay, complications, and check if hemorrhoids come back within one year.

Full description

Hemorrhoids are a very common condition, and when surgery is needed, there is no consensus on the best way to manage the surgical wound afterward. This single-center, prospective, randomized clinical trial aims to directly compare the clinical outcomes of the three primary wound management techniques: open, closed, and semi-closed hemorrhoidectomy.

A total of 378 patients will be randomly assigned to one of the three treatment groups. The primary focus is on comparing key short-term outcomes, including the time it takes for the wound to fully heal, the length of the hospital stay, and the rate of complications such as surgical site infection, bleeding, and urinary retention.

Secondary outcomes will provide a broader picture of patient recovery. Pain will be carefully assessed using a standardized pain scale (Visual Analog Scale) on multiple days after surgery and by tracking the total amount of pain medication required during hospitalization. Furthermore, to understand the long-term effectiveness of each technique, the study will follow patients for one year after surgery to assess their quality of life and monitor for any recurrence of hemorrhoids.

This is the first clinical trial to evaluate all three techniques within the same study. The results are expected to provide high-quality evidence to help surgeons choose the most effective wound management strategy, ultimately improving patient care and recovery after hemorrhoid surgery.

Enrollment: 378 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 to 75 years.
2. Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.
3. Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.
4. Willing and able to provide written informed consent.

Exclusion criteria

1. History of mental illness or cognitive impairment that may affect the ability to provide informed consent or comply with the study protocol.
2. Diagnosis of diabetes mellitus.
3. Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.
4. Inability or unwillingness to comply with scheduled follow-up visits.
5. Presence of severe perioperative comorbidities that render the patient unsuitable for the planned surgical protocol or anesthesia (as determined by the attending anesthesiologist or surgeon).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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378 participants in 3 patient groups

Open Hemorrhoidectomy Group

Experimental group

Description:

Patients in this group will undergo open hemorrhoidectomy. Following external stripping and internal ligation, the wound will be left open without any sutures for healing by secondary intention.

Treatment:

Procedure: Open Hemorrhoidectomy

Closed Hemorrhoidectomy Group

Experimental group

Description:

Patients in this group will undergo closed hemorrhoidectomy (Ferguson technique). After achieving hemostasis, the entire wound will be closed primarily using interrupted non-absorbable sutures.

Treatment:

Procedure: Closed Hemorrhoidectomy (Ferguson Technique)

Semi-Closed Hemorrhoidectomy Group

Experimental group

Description:

Patients in this group will undergo semi-closed hemorrhoidectomy. Following hemostasis, the distal half of the incision (away from the anal canal) will be closed with interrupted sutures, while the proximal half is left open.

Treatment:

Procedure: Semi-Closed Hemorrhoidectomy