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Single-incision Laparoscopic Surgery in Acute Abdomen

Primary Purpose

Acute Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hand-made glove setting
Commercialized single-incision multiport setting
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis focused on measuring Laparoscopic appendectomy, Single-incision laparoscopic appendectomy, Single-incision laparoscopic surgery setting, Simple appendicitis, Complicated appendicitis

Eligibility Criteria

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

Inclusion Criteria:

  1. The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis
  2. The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded

Exclusion Criteria:

  1. Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery
  2. Decide to receive non-surgical treatment of the acute appendicitis
  3. Age<20, or could not exercise the right of autonomy or unwilling to participate the study

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hand-made glove setting

commercialized multiport setting

Arm Description

The patients receive Hand-made glove setting

The patients receive commercialized single-incision multiport setting

Outcomes

Primary Outcome Measures

Postoperative pain
Postoperative pain is measured by visual pain scale
wound cosmesis
The cosmesis is measure by the length of the incision

Secondary Outcome Measures

Operative time
By chart review
Visceral/vascular injuries
Recorded on the operative note
Conversion
Recorded on the operative note
Wound infection/surgical site infection
By chart review
Intra-abdominal collection
Defined by evidence on any image modalities
Postoperative ileus
Defined by ileus physically or by image
Length of hospitalization
By chart review
Time to return work
By chart review

Full Information

First Posted
June 18, 2017
Last Updated
June 21, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03198065
Brief Title
Single-incision Laparoscopic Surgery in Acute Abdomen
Official Title
The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2017 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast, thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and effective, and further it achieves compatible results and outcomes in oncology and functional diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy, and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel disease). Under a superior heritage of surgical skills from Taiwan university hospital, we introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years, single-incisional laparoscopic surgery has emerged to become one of the focused topic in the world and seemly in our department. Through single-incision surgery, we attempted to minimize the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate two-step plans: first, by retrospective data collection, we can explain the clinical problems based on current statistical results. Second, based on prior (step 1) retrospective findings, a prospective study could be conducted for more evident results.
Detailed Description
The aim of this study is to compare two kinds of single-incision laparoscopic surgery setting including hand-made glove setting and commercialized single-incision multiport setting. The preoperative, intraoperative and postoperative data will be collected for analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
Keywords
Laparoscopic appendectomy, Single-incision laparoscopic appendectomy, Single-incision laparoscopic surgery setting, Simple appendicitis, Complicated appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hand-made glove setting
Arm Type
Experimental
Arm Description
The patients receive Hand-made glove setting
Arm Title
commercialized multiport setting
Arm Type
Experimental
Arm Description
The patients receive commercialized single-incision multiport setting
Intervention Type
Procedure
Intervention Name(s)
Hand-made glove setting
Intervention Description
The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy
Intervention Type
Procedure
Intervention Name(s)
Commercialized single-incision multiport setting
Intervention Description
The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain is measured by visual pain scale
Time Frame
around 2 years
Title
wound cosmesis
Description
The cosmesis is measure by the length of the incision
Time Frame
around 2 years
Secondary Outcome Measure Information:
Title
Operative time
Description
By chart review
Time Frame
around 2 years
Title
Visceral/vascular injuries
Description
Recorded on the operative note
Time Frame
around 2 years
Title
Conversion
Description
Recorded on the operative note
Time Frame
around 2 years
Title
Wound infection/surgical site infection
Description
By chart review
Time Frame
around 2 years
Title
Intra-abdominal collection
Description
Defined by evidence on any image modalities
Time Frame
around 2 years
Title
Postoperative ileus
Description
Defined by ileus physically or by image
Time Frame
around 2 years
Title
Length of hospitalization
Description
By chart review
Time Frame
around 2 years
Title
Time to return work
Description
By chart review
Time Frame
around 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded Exclusion Criteria: Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery Decide to receive non-surgical treatment of the acute appendicitis Age<20, or could not exercise the right of autonomy or unwilling to participate the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-tso Liao, M.D.
Phone
886-972-655-738
Email
Yutsoliao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng-shen Lai, M.D.
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-tso Liao, M.D.
Phone
886-972-655-738
Email
Yutsoliao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Single-incision Laparoscopic Surgery in Acute Abdomen

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