Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy.

ConditionHemorrhoids
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Putian University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 75 years.

Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.

Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.

Willing and able to provide written informed consent.

Disqualifiers

History of mental illness or cognitive impairment that may affect the ability to provide informed consent or comply with the study protocol.

Diagnosis of diabetes mellitus.

Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.

Inability or unwillingness to comply with scheduled follow-up visits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open Hemorrhoidectomy

    Procedure/Surgery

    Patients in this group undergo a hemorrhoidectomy procedure where, after external stripping and internal ligation, the surgical wound is left entirely open without sutures to heal by secondary intention. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.

  • Closed Hemorrhoidectomy (Ferguson Technique)

    Procedure/Surgery

    Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the entire surgical wound is closed primarily using interrupted non-absorbable sutures. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.

  • Semi-Closed Hemorrhoidectomy

    Procedure/Surgery

    Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the distal half of the incision (away from the anal canal) is closed with interrupted sutures, while the proximal half remains open. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.

Treatment groups

378 Participants
are divided into 3 treatment groups
Group A: Open Hemorrhoidectomy GroupExperimental treatment 1 intervention
Group B: Closed Hemorrhoidectomy GroupExperimental treatment 1 intervention
Group C: Semi-Closed Hemorrhoidectomy GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Wound healing time

The time required for complete wound healing, defined as 100% re-epithelialization of the surgical site with no exudate or scab, assessed by a blinded evaluator.

Time frame
Daily from postoperative Day 1 until complete epithelialization is achieved (assessed for up to 28 days post-surgery)

Secondary outcomes

1

Postoperative pain intensity (NRS score)

Pain intensity was evaluated on a 0 to 10 Numerical Rating Scale (NRS), with higher scores indicating more severe pain (0 = no pain; 10 = worst possible pain).

Time frame
Baseline (preoperative), and on postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).
2

Perianal edema severity

Severity of swelling around the surgical site evaluated by trained research nurses using a standardized 0-6 point scale.

Time frame
Postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).
3

Length of hospital stay

Duration of hospitalization measured in hours from the end of surgery to discharge, using standardized discharge criteria.

Time frame
From end of surgery until discharge (assessed up to 7 days postoperatively).
4

Complication incidence

Occurrence of postoperative complications (e.g., infection, bleeding, urinary retention) classified and graded using the Clavien-Dindo system.

Time frame
Within 30 days after surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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