Single-incision Laparoscopic Surgery in Acute Abdomen

Acute Appendicitis Clinical Trial

Official title:

The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198065
• Other study ID #: 201702076RIND
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2017
• Last updated: June 21, 2017
• Start date: June 17, 2017
• Est. completion date: July 2019

Study information

• Verified date: June 2017
• Source: National Taiwan University Hospital
• Contact: Yu-tso Liao, M.D.
• Phone: 886-972-655-738
• Email: Yutsoliao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• Hand-made glove setting
The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy
• Commercialized single-incision multiport setting
The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain is measured by visual pain scale	around 2 years
Primary	wound cosmesis	The cosmesis is measure by the length of the incision	around 2 years
Secondary	Operative time	By chart review	around 2 years
Secondary	Visceral/vascular injuries	Recorded on the operative note	around 2 years
Secondary	Conversion	Recorded on the operative note	around 2 years
Secondary	Wound infection/surgical site infection	By chart review	around 2 years
Secondary	Intra-abdominal collection	Defined by evidence on any image modalities	around 2 years
Secondary	Postoperative ileus	Defined by ileus physically or by image	around 2 years
Secondary	Length of hospitalization	By chart review	around 2 years
Secondary	Time to return work	By chart review	around 2 years