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Completed

NCT Number: NCT05602987

Comparison Study of the Effect of Enema in Anal Surgery

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

About this study

For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
  • Patients who underwent fistulotomy or fistulectomy

Exclusion criteria

  • Emergency surgery
  • Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
  • Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
  • Other types of anal surgery, e.g., anal fissure and colorectal cancer
  • Liver cirrhosis
  • Coagulation dysfunction
  • Bedridden
  • Human immunodeficiency virus infection

Treatment and study plan

enema

Procedure

receiving enema at the night before anal surgery

no enema

Procedure

no enema before anal surgery

Primary outcomes

  1. Pain score

    Time frame: On postoperative day 0 to day 7

    record max pain score(visual analog scale:0-10) each day

  2. Consumption of analgesics

    Time frame: On postoperative day 0 to day 7

    daily consumption of oral analgesics from post-operative day 0 to day 7

Secondary outcomes

  1. Incidence of surgical site infection

    Time frame: On postoperative day 0-30

    Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.

  2. Incidence of Urinary retention

    Time frame: On postoperative day 0 to day 7

    patients requiring foley catheterization during hospital stay

  3. First defecation after surgery

    Time frame: On postoperative day 0 to day 7

    Time between first defecation and operation

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
Nov 22, 2023

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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