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

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

Study Overview

• Status: Completed
• Conditions: Gallbladder Stone; Gallbladder Polyp
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Department of hepatobiliary surgery,China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LALC; lower abdominal laparoscopic cholecystectomy	Procedure: laparoscopic cholecystectomy; Other Names: lower abdominal three-port laparoscopic cholecystectomy; single port laparoscopic cholecystectomy; upper abdominal three-port laparoscopic cholecystectomy
Experimental: SLC; single laparoscopic cholecystectomy	Procedure: laparoscopic cholecystectomy; Other Names: lower abdominal three-port laparoscopic cholecystectomy; single port laparoscopic cholecystectomy; upper abdominal three-port laparoscopic cholecystectomy
Placebo Comparator: UALC; upper abdominal laparoscopic cholecystectomy	Procedure: laparoscopic cholecystectomy; Other Names: lower abdominal three-port laparoscopic cholecystectomy; single port laparoscopic cholecystectomy; upper abdominal three-port laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systematic inflammatory response caused by the surgical trauma	Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,	one day before the operation,8 hours after the operation,one day after the operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Cosmesis and body image score	1 and 3 months after the operation
pulmonary function	one day before the operation, one day after the operation
Post-operation pain score (visual analog scale, VAS)	12 and 24 hours after the operation
36-item health survey	3 months after the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative indexes	operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay	perioperative period

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Chen Wang, MD, China-Japan Friednship Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 6, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 2014-21 (Ethic committee of China-Japan Friendship Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED