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

Sponsor

Kyunghee University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01007318

Collaborator

KyungHee University School of Medicine, Korea (Other)

194

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis	Procedure: Single port laparoscopic appendectomy Procedure: 3 port laparoscopic appendectomy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single port 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.	Procedure: Single port laparoscopic appendectomy Single port through the transumbilical 2-cm incision Other Names: single port laparoscopic surgery
Active Comparator: 3 port 3 port laparoscopic appendectomy was done by conventional method	Procedure: 3 port laparoscopic appendectomy 3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area Other Names: conventional laparoscopic appendectomy

Arm

Intervention/Treatment

Active Comparator: Single port

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.

Procedure: Single port laparoscopic appendectomy

Single port through the transumbilical 2-cm incision

Other Names:

single port laparoscopic surgery

Active Comparator: 3 port

3 port laparoscopic appendectomy was done by conventional method

Procedure: 3 port laparoscopic appendectomy

3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area

Other Names:

conventional laparoscopic appendectomy

Outcome Measures

Primary Outcome Measures

Safety [1 month]
30 day morbidity and mortality

Secondary Outcome Measures

Efficacy [1 day]
Operative time
Efficacy [2 days]
Postoperative pain score
Efficacy [2 days]
Postoperative functional recovery
Efficacy [7 days]
Duration of postoperative hospital stay
Efficacy [7 days]
Cost

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University School of Medicine, Neo Medical Center	Seoul		Korea, Republic of	134-727

Sponsors and Collaborators

Kyunghee University Medical Center
KyungHee University School of Medicine, Korea

Investigators

Principal Investigator: Suk Hwan Lee, MD. PhD, Kyung Hee University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Byung Mo Kang, Professor, Kyunghee University Medical Center

ClinicalTrials.gov Identifier:

NCT01007318

Other Study ID Numbers:

khnmc IRB 2009-026

First Posted:

Nov 4, 2009

Last Update Posted:

Sep 7, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Appendicitis

Study Results

No Results Posted as of Sep 7, 2020