ClinicalTrials.gg
Status unknownNCT01625247Updated Jun 21, 2012

Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

A Phase 3 interventional study of Surgical drainage in Acute Cholecystitis and Empyema, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-06-21.

Sponsored by Yonsei University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.

02

Conditions studied

  • Acute Cholecystitis
  • Empyema
03

In context

Cholecystitis, Acute

140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.

This study's planned enrollment of 162 is above the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.

Browse Cholecystitis, Acute studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute cholecystis
  • Laparoscopic cholecystectomy
  • KAROFSKY PERFORMANCE SCALE > 70
  • No history of major operation

Exclusion criteria

Exclusion Criteria:

  • class > 3
  • Open cholecystectomy
  • No- compliance
  • Intraoperative injuries
  • Inadequate hemostasis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    1 arm

    Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.

    Procedure: Surgical drainage

  • Active comparator
    2 arm

    Patients under LC. Allocation to sham drain,

    Procedure: Surgical drainage

Interventions

  • ProcedureSurgical drainage

    Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.

06

What researchers measure

Primary outcomes

  1. frequency of postoperative complication occurrence

    Time frame: whinin 1 week and 8 weeks postoperatively

07

Study locations

1 of 1 sites recruiting
  • Gangnam Severance hospital
    Seoul, 135-720, Korea, Republic of
    Recruiting
    • Dong Sup Yoon, MD · Contactyds1660@yuhs.ac · 82-2-2019-2444
    • Dong Sup Yoon, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01625247
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 21, 2012
Start date
Jun 2009
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jun 21, 2012

Study contacts

Dong Sup Yoon, MD
Contact
yds1660@yuhs.ac
82-2-2019-2444

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion