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

NCT07196865 | Not Yet Recruiting DMC

• 1 other identifier: AHPutianU 2025918
• Study Type: interventional
• Target: 378
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemorrhoids

Outcome Measures

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.

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

Secondary Outcomes (4)

• Postoperative pain intensity (NRS score)

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

• Perianal edema severity

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

• Length of hospital stay

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

• Complication incidence

  Within 30 days after surgery.

Study Arms (3)

Open Hemorrhoidectomy Group

EXPERIMENTAL

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.

Procedure: Open Hemorrhoidectomy

Closed Hemorrhoidectomy Group

EXPERIMENTAL

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.

Procedure: Closed Hemorrhoidectomy (Ferguson Technique)

Semi-Closed Hemorrhoidectomy Group

EXPERIMENTAL

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.

Procedure: Semi-Closed Hemorrhoidectomy

Interventions

Open Hemorrhoidectomy PROCEDURE

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.

Open Hemorrhoidectomy Group

Closed Hemorrhoidectomy (Ferguson Technique) PROCEDURE

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.

Closed Hemorrhoidectomy Group

Semi-Closed Hemorrhoidectomy PROCEDURE

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.

Semi-Closed Hemorrhoidectomy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chenxing Jian C Chen, doctoral

CONTACT

86-139559538950; ptyyjcx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm, parallel-group, randomized controlled trial (RCT). Participants are randomly allocated in a 1:1:1 ratio to one of three distinct intervention groups, where they receive only that specific surgical intervention and are followed concurrently throughout the study period. The groups are defined by the wound management technique used after hemorrhoidectomy: Group 1 (Open): Wound left unsutured. Group 2 (Closed):Wound fully closed with interrupted non-absorbable sutures. Group 3 (Semi-Closed): Distal half of the incision closed with interrupted sutures.

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03