Single-incision Laparoscopic Surgery in Acute Abdomen

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: Hand-made glove setting; Procedure: Commercialized single-incision multiport setting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-tso Liao, M.D.; Phone Number: 886-972-655-738; Email: Yutsoliao@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yu-tso Liao, M.D.; Phone Number: 886-972-655-738; Email: Yutsoliao@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand-made glove setting; The patients receive Hand-made glove setting	Procedure: Hand-made glove setting; The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy
Experimental: commercialized multiport setting; The patients receive commercialized single-incision multiport setting	Procedure: Commercialized single-incision multiport setting; The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain is measured by visual pain scale	around 2 years
wound cosmesis	The cosmesis is measure by the length of the incision	around 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	By chart review	around 2 years
Visceral/vascular injuries	Recorded on the operative note	around 2 years
Conversion	Recorded on the operative note	around 2 years
Wound infection/surgical site infection	By chart review	around 2 years
Intra-abdominal collection	Defined by evidence on any image modalities	around 2 years
Postoperative ileus	Defined by ileus physically or by image	around 2 years
Length of hospitalization	By chart review	around 2 years
Time to return work	By chart review	around 2 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Peng-shen Lai, M.D., National Taiwan University Hospital, Yun-Lin Branch

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: June 18, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Complicated appendicitis; Laparoscopic appendectomy; Single-incision laparoscopic appendectomy; Single-incision laparoscopic surgery setting; Simple appendicitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Pain; Neurologic Manifestations; Wounds and Injuries; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Abdominal Pain; Surgical Wound; Appendicitis; Abdomen, Acute
• Other Study ID Numbers: 201702076RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No