Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial
1 other identifier
interventional
208
1 country
1
Brief Summary
Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 15, 2015
March 1, 2015
2.5 years
June 10, 2015
July 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of complications
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
30 days
Secondary Outcomes (5)
mortality rate
30 days
cosmetic results
30 days
operative time
intraoperative
time to recover
14 days
Pain score
14 days
Study Arms (2)
suprapubic single-incision laparoscopic appendectomy
EXPERIMENTALsingle incision laparoscopic surgery will be performed for patients in this group.
conventional multiport appendectomy
ACTIVE COMPARATORConventional laparoscopic surgery will be performed for patients in this group.
Interventions
the approach of appendectomy
Eligibility Criteria
You may qualify if:
- acute appendicitis or interval appendicitis
- informed consent
You may not qualify if:
- diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems)
- history of cirrhosis and coagulation disorders
- suspected or proven malignancy
- contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- inability to give informed consent(severe mental disease)
- pregnancy
- BMI\>30kg/m2
- generalized peritonitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515, China
Related Publications (2)
Yu J, Wang YN, Hu YF, Cheng X, Zhen L, Li GX. Single-incision laparoscopic appendectomy performed above the pubic symphysis - a new scarless approach. Minim Invasive Ther Allied Technol. 2011 Jan;20(1):18-21. doi: 10.3109/13645706.2010.518672.
PMID: 21222504RESULTWang Y, Xiong W, Lan X, Zhang J, Chen T, Liu H, Li G. Suprapubic single incision laparoscopic appendectomy. J Surg Res. 2015 Feb;193(2):577-82. doi: 10.1016/j.jss.2014.07.064. Epub 2014 Aug 4.
PMID: 25179807RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoxin Li, M.D.,Ph. D.
Nanfang Hospital, Southern Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2015
First Posted
July 15, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
July 15, 2015
Record last verified: 2015-03