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Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial

Primary Purpose

Complications

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
suprapubic single-incision laparoscopic appendectomy
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications focused on measuring Appendicitis, Appendectomy, Single-incision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute appendicitis or interval appendicitis
  • informed consent

Exclusion Criteria:

  • 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

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

suprapubic single-incision laparoscopic appendectomy

conventional multiport appendectomy

Arm Description

single incision laparoscopic surgery will be performed for patients in this group.

Conventional laparoscopic surgery will be performed for patients in this group.

Outcomes

Primary Outcome Measures

incidence of complications
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery

Secondary Outcome Measures

mortality rate
cosmetic results
Cosmetic assessment is perform using body image scale and cosmetic scale.
operative time
time to recover
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.

Full Information

First Posted
June 10, 2015
Last Updated
July 13, 2015
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02499016
Brief Title
Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial
Official Title
Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications
Keywords
Appendicitis, Appendectomy, Single-incision

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
suprapubic single-incision laparoscopic appendectomy
Arm Type
Experimental
Arm Description
single incision laparoscopic surgery will be performed for patients in this group.
Arm Title
conventional multiport appendectomy
Arm Type
Active Comparator
Arm Description
Conventional laparoscopic surgery will be performed for patients in this group.
Intervention Type
Procedure
Intervention Name(s)
suprapubic single-incision laparoscopic appendectomy
Other Intervention Name(s)
SSILA
Intervention Description
the approach of appendectomy
Primary Outcome Measure Information:
Title
incidence of complications
Description
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
mortality rate
Time Frame
30 days
Title
cosmetic results
Description
Cosmetic assessment is perform using body image scale and cosmetic scale.
Time Frame
30 days
Title
operative time
Time Frame
intraoperative
Title
time to recover
Time Frame
14 days
Title
Pain score
Description
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute appendicitis or interval appendicitis informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, M.D.,Ph. D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanan Wang, M.D
Phone
+86-150-1875-3181
Email
wyn8116@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,Ph. D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name & Degree
Yanan Wang, M.D.
Phone
+86-150-1875-3181
Email
wyn8116@163.com
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
21222504
Citation
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.
Results Reference
result
PubMed Identifier
25179807
Citation
Wang 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.
Results Reference
result

Learn more about this trial

Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial

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