NCT02738710

Brief Summary

This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

April 5, 2016

Last Update Submit

March 28, 2018

Conditions

Pain, PostoperativeGallstone

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    visual analog scale (0-10)

    7 days postoperatively

Secondary Outcomes (2)

  • wound infection

    at 1 week and 1 month postoperatively

  • patient satisfaction

    1 week and 3 months postoperatively

Study Arms (2)

transumbilical wound

EXPERIMENTAL

transumbilical incision

Procedure: transumbilical incision

infra umbilical wound

ACTIVE COMPARATOR

infra umbilical incision

Procedure: Infra umbilical incision

Interventions

transumbilical incisionPROCEDURE

incision within umbilicus

transumbilical wound
Infra umbilical incisionPROCEDURE

incision about 1 cm below umbilicus

infra umbilical wound

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic cholecystectomy
  • willing to participate

You may not qualify if:

  • pregnancy
  • immunocompromised host
  • on continuous ambulatory peritoneal dialysis
  • morbid obesity (Body mass index \> 35 kg/m2)
  • End-stage renal disease with hemodialysis dependent
  • ascites
  • uncontrolled coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Pathumtani, 12120, Thailand

Location

Related Publications (1)

  • Siribumrungwong B, Chunsirisub T, Limpavitayaporn P, Tongyoo A, Sriussadaporn E, Mingmalairak C, Thowprasert W, Thakkinstian A. Comparison of postoperative pain at umbilical wound after conventional laparoscopic cholecystectomy between transumbilical and infraumbilical incisions: a randomized control trial. Surg Endosc. 2019 May;33(5):1578-1584. doi: 10.1007/s00464-018-6447-y. Epub 2018 Oct 22.

    PMID: 30350096DERIVED

MeSH Terms

Conditions

Pain, PostoperativeGallstones

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsCholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, Anatomical

Study Officials

  • Trilak Chunsurisap

    Thammasat University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 14, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

TH(1)