Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Kyunghee University Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kyunghee University Medical Center
Collaborator:
KyungHee University School of Medicine, Korea
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01007318
First received: November 3, 2009
Last updated: May 26, 2010
Last verified: November 2009
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Purpose
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 | Intervention |
|---|---|
|
Appendicitis |
Procedure: Single port laparoscopic appendectomy Procedure: 3 port laparoscopic appendectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis |
Resource links provided by NLM:
Further study details as provided by Kyunghee University Medical Center:
Primary Outcome Measures:
- Safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]30 day morbidity and mortality
Secondary Outcome Measures:
- Efficacy [ Time Frame: 1 day ] [ Designated as safety issue: No ]Operative time
- Efficacy [ Time Frame: 2 days ] [ Designated as safety issue: No ]Postoperative pain score
- Efficacy [ Time Frame: 2 days ] [ Designated as safety issue: No ]Postoperative functional recovery
- Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]Duration of postoperative hospital stay
- Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]Cost
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: conventional laparoscopic appendectomy
|
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.
Eligibility| Ages Eligible for Study: | 7 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007318
Contacts
| Contact: Byung Mo Kang, MD | 82-2-440-6260 | kbm0728@yahoo.co.kr |
Locations
| Korea, Republic of | |
| Kyung Hee University School of Medicine, Neo Medical Center | Recruiting |
| Seoul, Korea, Republic of, 134-727 | |
| Contact: Byung Mo Kang, MD. 82-2-440-6260 kbm0728@yahoo.co.kr | |
| Principal Investigator: Suk Hwan Lee, MD. PhD | |
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 |
More Information
No publications provided
| Responsible Party: | Suk Hwan Lee, Kyung Hee University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01007318 History of Changes |
| Other Study ID Numbers: | khnmc IRB 2009-026 |
| Study First Received: | November 3, 2009 |
| Last Updated: | May 26, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013