Single-incision Laparoscopic Surgery in Acute Abdomen

National Taiwan University

Status: Unknown

Conditions: Acute Appendicitis

Treatments: Procedure: Hand-made glove setting; Procedure: Commercialized single-incision multiport setting

Study type: Interventional

Funder types: Other

Identifiers

NCT03198065

201702076RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Hand-made glove setting

Experimental group

Description:

The patients receive Hand-made glove setting

Treatment:

Procedure: Hand-made glove setting

commercialized multiport setting

Experimental group

Description:

The patients receive commercialized single-incision multiport setting

Treatment:

Procedure: Commercialized single-incision multiport setting