Single-incision Laparoscopic Surgery in Acute Abdomen

NCT03198065 | Unknown

• 1 other identifier: 201702076RIND
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Appendicitis

Keywords

Laparoscopic appendectomy; Single-incision laparoscopic appendectomy; Single-incision laparoscopic surgery setting; Simple appendicitis; Complicated appendicitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (2)

Hand-made glove setting

EXPERIMENTAL

The patients receive Hand-made glove setting

Procedure: Hand-made glove setting

commercialized multiport setting

EXPERIMENTAL

The patients receive commercialized single-incision multiport setting

Procedure: Commercialized single-incision multiport setting

Interventions

Hand-made glove setting PROCEDURE

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

Hand-made glove setting

Commercialized single-incision multiport setting PROCEDURE

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

commercialized multiport setting

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients admitted to the NTUH Yunlin branch diagnosed clinically as acute appendicitis
• The patients with clinically suspected right lower quadrant pain and acute appendicitis could not be excluded

You may not qualify if:

• Not eligible to underwent laparoscopic surgery because of compromised cardiopulmonary function or major laparotomy surgery
• Decide to receive non-surgical treatment of the acute appendicitis
• Age\<20, or could not exercise the right of autonomy or unwilling to participate the study

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Peng-shen Lai, M.D.

  National Taiwan University Hospital, Yun-Lin Branch

  STUDY DIRECTOR

Central Study Contacts

Yu-tso Liao, M.D.

CONTACT

886-972-655-738; Yutsoliao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 23, 2017
• Study Start: June 17, 2017
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)