Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02738710
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Boonying Siribumrungwong, Thammasat University

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Gallstone Procedure: transumbilical incision Procedure: Infra umbilical incision Not Applicable

Detailed Description:
Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: transumbilical wound
transumbilical incision
Procedure: transumbilical incision
incision within umbilicus

Active Comparator: infra umbilical wound
infra umbilical incision
Procedure: Infra umbilical incision
incision about 1 cm below umbilicus

Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 7 days postoperatively ]
    visual analog scale (0-10)

Secondary Outcome Measures :
  1. wound infection [ Time Frame: at 1 week and 1 month postoperatively ]
    yes or no according to Center for Disease Control and Prevention (CDC) criteria

  2. patient satisfaction [ Time Frame: 1 week and 3 months postoperatively ]
    Visual analog scale (0-10)

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • elective laparoscopic cholecystectomy
  • willing to participate

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02738710

Thammasat University Hospital
Khlong Luang, Pathumtani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Study Chair: Trilak Chunsurisap Thammasat University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boonying Siribumrungwong, Dr., Thammasat University Identifier: NCT02738710     History of Changes
Other Study ID Numbers: MTU-EC-SU-1-042/59
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical