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Completed

NCT Number: NCT05605080

Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery

To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

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Key information

Conditions

Hemorrhoids Anal Fistula Cardiovascular Diseases Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Vascular Diseases

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

Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these patients underwent surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's personal preference according to their experiences. Shuang Ho hospital has top three quantity of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
  • Patients who undergo fistulectomy or fistulotomy are include.

Exclusion criteria

  • Emergency operation
  • Patients with colorectal cancer
  • Liver cirrhosis
  • Patients with coagulopathy
  • Patients with HIV infection

Treatment and study plan

Gelfoam

Device

Use Gelfoam as a hemostatic agent after anal surgery.

Bosmin gauze

Other

Use bosmin gauze as a hemostatic agent after anal surgery.

Primary outcomes

  1. Post-operative pain

    Time frame: 0-7 days

    Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.

  2. Analgesic agent use

    Time frame: 0-7days

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

Secondary outcomes

  1. Incidence of post-operative bleeding

    Time frame: 0-30 days

    Postoperative delayed bleeding was defined as (1) when the bleeding required surgical intervention or (2) when hospital re-admission was warranted after patient discharge.

  2. Incidence of urinary retention

    Time frame: 0-7 days

    Urinary retention was defined as patients requiring Foley catheterization during the hospital stay

  3. Incidence of surgical site infection

    Time frame: 0-30 days

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

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 4, 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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