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

NCT ID: NCT02499016

Last Updated: 2015-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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suprapubic single-incision laparoscopic appendectomy

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

Group Type EXPERIMENTAL

suprapubic single-incision laparoscopic appendectomy

Intervention Type PROCEDURE

the approach of appendectomy

conventional multiport appendectomy

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

Group Type ACTIVE_COMPARATOR

suprapubic single-incision laparoscopic appendectomy

Intervention Type PROCEDURE

the approach of appendectomy

Interventions

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suprapubic single-incision laparoscopic appendectomy

the approach of appendectomy

Intervention Type PROCEDURE

Other Intervention Names

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SSILA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guoxin Li, M.D.,Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University, China

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guoxin Li, M.D.,Ph. D.

Role: CONTACT

+86-138-0277-1450

Yanan Wang, M.D

Role: CONTACT

+86-150-1875-3181

Facility Contacts

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Guoxin Li, M.D., Ph.D.

Role: primary

+86-138-0277-1450

Yanan Wang, M.D.

Role: backup

+86-150-1875-3181

References

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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.

Reference Type RESULT
PMID: 21222504 (View on PubMed)

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.

Reference Type RESULT
PMID: 25179807 (View on PubMed)

Other Identifiers

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NFGS-SSILA-01

Identifier Type: -

Identifier Source: org_study_id

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