Single-incision Laparoscopic Surgery in Acute Abdomen

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

Sponsors

Lead Sponsor: National Taiwan University Hospital

Source National Taiwan University Hospital
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.

Overall Status Unknown status
Start Date June 17, 2017
Completion Date July 2019
Primary Completion Date June 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative pain around 2 years
wound cosmesis around 2 years
Secondary Outcome
Measure Time Frame
Operative time around 2 years
Visceral/vascular injuries around 2 years
Conversion around 2 years
Wound infection/surgical site infection around 2 years
Intra-abdominal collection around 2 years
Postoperative ileus around 2 years
Length of hospitalization around 2 years
Time to return work around 2 years
Enrollment 30
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Hand-made glove setting

Description: The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy

Arm Group Label: Hand-made glove setting

Intervention Type: Procedure

Intervention Name: Commercialized single-incision multiport setting

Description: The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy

Arm Group Label: commercialized multiport setting

Eligibility

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Peng-shen Lai, M.D. Study Director National Taiwan University Hospital, Yun-Lin Branch
Overall Contact

Last Name: Yu-tso Liao, M.D.

Phone: 886-972-655-738

Email: [email protected]

Location
Facility: Status: Contact: National Taiwan University Hospital Yu-tso Liao, M.D. 886-972-655-738 [email protected]
Location Countries

Taiwan

Verification Date

June 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Hand-made glove setting

Type: Experimental

Description: The patients receive Hand-made glove setting

Label: commercialized multiport setting

Type: Experimental

Description: The patients receive commercialized single-incision multiport setting

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov