Clinical trial NCT03198065: Single-incision Laparoscopic Surgery in Acute Abdomen
Official title: The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Appendicitis
Keywords: Laparoscopic appendectomy
Single-incision laparoscopic appendectomy
Single-incision laparoscopic surgery setting
Simple appendicitis
Complicated appendicitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative pain
timeFrame: around 2 years
measure: wound cosmesis
timeFrame: around 2 years
Secondary outcomes:
measure: Operative time
timeFrame: around 2 years
measure: Visceral/vascular injuries
timeFrame: around 2 years
measure: Conversion
timeFrame: around 2 years
measure: Wound infection/surgical site infection
timeFrame: around 2 years
measure: Intra-abdominal collection
timeFrame: around 2 years
measure: Postoperative ileus
timeFrame: around 2 years
measure: Length of hospitalization
timeFrame: around 2 years
measure: Time to return work
timeFrame: around 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Peng-shen Lai, M.D.
role: STUDY_DIRECTOR
References: