NCT03909360

Brief Summary

Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

March 17, 2019

Last Update Submit

April 12, 2019

Conditions

CholecystitisCholecystolithiasisPolyps GallbladderAdenomyosis of Gallbladder

Outcome Measures

Primary Outcomes (5)

  • bleeding Bile leakage

    the morbidity of bleeding the morbidity of bile leakage

    day 1 to one month post LC operation

  • bile leakage

    the morbidity of bile leakage

    day 1 to one month post LC operation

  • Puncture drainage Puncture drainage

    the percentage of puncture drainage Puncture drainage Puncture drainage

    day 1 to one month post LC operation

  • reoperation Reoperation

    the percentage of reoperation

    day 1 to one month post LC operation

  • readmission

    the percentage of readmission

    day 1 to one month post LC operation

Secondary Outcomes (5)

  • hospital stay

    day 1 to discharge post LC operation

  • Hospitalization expenses

    day 1 to discharge post LC operation

  • VAS score

    day 1 to discharge post LC operation

  • Nausea and vomiting

    day 1 to discharge post LC operation

  • infection

    day 1 to discharge post LC operation

Study Arms (2)

drainage

EXPERIMENTAL

Placement of subhepatic drainage tube for laparoscopic cholecytetomy

Procedure: drainage tube

no drainage

NO INTERVENTION

no placement of subhepatic drainage tube for laparoscopic cholecytetomy

Interventions

drainage tubePROCEDURE

sub-hepatic drainage tube for laparoscopic cholecystectomy

drainage

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age:18-75 years old
  • indicated and planed to receive laparoscopic cholecystectomy

You may not qualify if:

  • cirrohosis Child Grading B and C
  • upper abdominal surgery history
  • adjustment of surgical name intraoperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

  • Zhu H, Liu D, Zhou D, Wu J, Yu Y, Jin Y, Ye D, Ding C, Zhang X, Huang B, Peng S, Li J. Effectiveness of no drainage after elective day-case laparoscopic cholecystectomy, even with intraoperative gallbladder perforation: a randomized controlled trial. Langenbecks Arch Surg. 2023 Mar 1;408(1):112. doi: 10.1007/s00423-023-02846-z.

    PMID: 36856748DERIVED

MeSH Terms

Conditions

CholecystitisCholecystolithiasis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Officials

  • Jiangtao Li, MD

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huanbing Zhu, MD

CONTACT

15857174159juvanbn@msn.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2019

First Posted

April 10, 2019

Study Start

March 14, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)