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Completed

NCT Number: NCT04787458

Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.

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Key information

Conditions

Laparoscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, South Korea

About this study

Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-65 years old
  • American Society of Anesthesiologists Physical Status classification I and II

Exclusion criteria

  • history of ventral hernia
  • walking disability
  • chronic obstructive respiratory disease
  • malignancy
  • chronic pain syndrome
  • open conversion
  • inability to complete the questionnaire

Treatment and study plan

abdomen binder (Sejung Korea, Seoul, Republic of Korea)

Device

abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)

Primary outcomes

  1. degree of comfort

    Time frame: Until dischage, an average of 2.5 days

    Questionnaire response options ranged from very comfortable (5) to very Questionnaire response options ranged from very comfortable (5) to very uncomfortable (0).

  2. postoperative pain

    Time frame: 12 hours after surgery

    Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery

  3. postoperative pain

    Time frame: 24 hours after surgery

    Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery

  4. postoperative pain

    Time frame: 48 hours after surgery

    Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery

Secondary outcomes

  1. Postoperative hospital stay

    Time frame: Until dischage, an average of 2.3 days

    Postoperative hospital stay days to discharge

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 8, 2021
Registry last updated
Mar 8, 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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