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Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single port laparoscopic appendectomy
3 port laparoscopic appendectomy
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

7 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed acute appendicitis

Exclusion Criteria:

  • Age less than 7 or more than 75 years old
  • Gangrenous appendicitis
  • Combined generalized peritonitis
  • ASA score more than 3 point
  • Pregnant women
  • Cases requiring draining tube

Sites / Locations

  • Kyung Hee University School of Medicine, Neo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single port

3 port

Arm Description

Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.

3 port laparoscopic appendectomy was done by conventional method

Outcomes

Primary Outcome Measures

Safety
30 day morbidity and mortality

Secondary Outcome Measures

Efficacy
Operative time
Efficacy
Postoperative pain score
Efficacy
Postoperative functional recovery
Efficacy
Duration of postoperative hospital stay
Efficacy
Cost

Full Information

First Posted
November 3, 2009
Last Updated
September 3, 2020
Sponsor
Kyunghee University Medical Center
Collaborators
KyungHee University School of Medicine, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01007318
Brief Title
Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis
Official Title
Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
KyungHee University School of Medicine, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.
Detailed Description
Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single port
Arm Type
Active Comparator
Arm Description
Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.
Arm Title
3 port
Arm Type
Active Comparator
Arm Description
3 port laparoscopic appendectomy was done by conventional method
Intervention Type
Procedure
Intervention Name(s)
Single port laparoscopic appendectomy
Other Intervention Name(s)
single port laparoscopic surgery
Intervention Description
Single port through the transumbilical 2-cm incision
Intervention Type
Procedure
Intervention Name(s)
3 port laparoscopic appendectomy
Other Intervention Name(s)
conventional laparoscopic appendectomy
Intervention Description
3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
Primary Outcome Measure Information:
Title
Safety
Description
30 day morbidity and mortality
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Efficacy
Description
Operative time
Time Frame
1 day
Title
Efficacy
Description
Postoperative pain score
Time Frame
2 days
Title
Efficacy
Description
Postoperative functional recovery
Time Frame
2 days
Title
Efficacy
Description
Duration of postoperative hospital stay
Time Frame
7 days
Title
Efficacy
Description
Cost
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed acute appendicitis Exclusion Criteria: Age less than 7 or more than 75 years old Gangrenous appendicitis Combined generalized peritonitis ASA score more than 3 point Pregnant women Cases requiring draining tube
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk Hwan Lee, MD. PhD
Organizational Affiliation
Kyung Hee University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University School of Medicine, Neo Medical Center
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29340826
Citation
Kang BM, Choi SI, Kim BS, Lee SH. Single-port laparoscopic surgery in uncomplicated acute appendicitis: a randomized controlled trial. Surg Endosc. 2018 Jul;32(7):3131-3137. doi: 10.1007/s00464-018-6028-0. Epub 2018 Jan 16.
Results Reference
derived

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Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

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