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NCT Number: NCT05053542

The Necessity of Preoperative Bowel Preparation

Hemorrhoidectomy is an common treatment for high-grade hemorrhoids. The necessity of preoperative bowel preparation (PBP) in hemorrhoidectomy is inconclusive. This study aims to evaluate the benefit and safety of PBP in hemorrhoidectomy.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

About this study

Hemorrhoidectomy is an effective treatment for high-grade hemorrhoids and is recommended in patients with grade III-IV hemorrhoids. Common hemorrhoidectomy approaches include stapled hemorrhoidopexy and conventional procedures, such as Ferguson hemorrhoidectomy and Milligan-Morgan hemorrhoidectomy. Conventional techniques produce a lower recurrence rate, whereas stapled hemorrhoidopexy is associated with fewer postoperative complications and shorter recovery time.

Common complications after hemorrhoidectomy include urinary retention, pain, and delayed hemorrhage. Surgical site infection is a rare complication after hemorrhoid excision. Traditional opinions held that preoperative bowel preparation (PBP) reduces fecal mass and bacterial count in the bowel lumen, minimizing the risk of infective and anastomotic complications. However, a study that evaluated intramucosal bacterial count demonstrated that PBP does not reduce the colon bacterial count. A randomized control trial (RCT) evaluating the effect of PBP before colorectal surgery suggested that the procedure can be omitted. However, another RCT with 79 participants revealed that bowel preparation before anorectal surgery can result in less pain during the first postoperative defecation. A meta-analysis with 36 studies concluded that PBP before elective colorectal surgery does not affect the postoperative complication rate. On the contrary, the necessity of PBP before anorectal surgeries remains unreported. The choice of whether PBP has to be performed is often the surgeon's preference. It may be challenging for physicians to determine the appropriate decision of PBP before hemorrhoidectomy to reduce postoperative complications while minimizing patient discomfort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients underwent hemorrhoidectomy

Exclusion criteria

  • Patients who had received emergent or other anorectal surgery, such as fistulectomy, were excluded.

Treatment and study plan

enema

Procedure

Patients in the PBP group underwent a cleansing enema procedure with a solution of monosodium phosphate and disodium phosphate (EVAC enema 118 mL/bot, Purzer Pharmaceutical Co., Ltd) before hemorrhoidectomy, whereas patients in the non-PBP group skipped the procedure.

Primary outcomes

  1. Post-operative pain and

    Time frame: 4 weeks

    A numerical rating scale (NRS) was used for measuring daily postoperative pain, where 0 represented no pain and 10 represented the worst pain ever experienced.

  2. Post-operative oral analgesic use.

    Time frame: 4 weeks

    The daily dose of oral analgesics was recorded to represent patients' dependence on medicine for postoperative pain control.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

The Necessity of Preoperative Bowel Preparation for Hemorrhoidectomy: A Single-Center Retrospective Comparative Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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