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Completed

NCT Number: NCT02738710

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

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

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Key information

Conditions

Pain, Postoperative Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstone Gallstones Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thammasat University Hospital

Khlong Luang, Pathumtani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

transumbilical incision

Procedure

incision within umbilicus

Infra umbilical incision

Procedure

incision about 1 cm below umbilicus

Primary outcomes

  1. Postoperative pain

    Time frame: 7 days postoperatively

    visual analog scale (0-10)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Mar 29, 2018

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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