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NCT Number: NCT02185586

A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy

We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).

We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.

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Key information

Conditions

Gallbladder Stone Biliary Tract Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallbladder Polyp

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of hepatobiliary surgery,China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age from 18 to 70 years old
  • benign diseases of gallbladder
  • selective cholecystectomy
  • Capable to read and write

Exclusion criteria

  • accept upper abdominal operation before
  • acute cholecystitis
  • with serious heart or pulmonary diseases
  • with diseases of immune system
  • Pregnant women
  • can not understand the research purposes
  • relatives of researchers

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Other names: lower abdominal three-port laparoscopic cholecystectomy, single port laparoscopic cholecystectomy, upper abdominal three-port laparoscopic cholecystectomy

Primary outcomes

  1. Systematic inflammatory response caused by the surgical trauma

    Time frame: one day before the operation,8 hours after the operation,one day after the operation

    Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,

Secondary outcomes

  1. Cosmesis and body image score

    Time frame: 1 and 3 months after the operation

  2. pulmonary function

    Time frame: one day before the operation, one day after the operation

  3. Post-operation pain score (visual analog scale, VAS)

    Time frame: 12 and 24 hours after the operation

  4. 36-item health survey

    Time frame: 3 months after the operation

Other outcomes

  1. perioperative indexes

    Time frame: perioperative period

    operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2014
Registry last updated
Jan 23, 2020

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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