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Single-incision Laparoscopic Surgery in Acute Abdomen

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ClinicalTrials.gov Identifier: NCT03198065
Recruitment Status : Unknown
Verified June 2017 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Procedure: Hand-made glove setting Procedure: Commercialized single-incision multiport setting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Application of Minimally Invasive Single-incision Laparoscopic Surgery in Acute Abdomen
Actual Study Start Date : June 17, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

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




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: around 2 years ]
    Postoperative pain is measured by visual pain scale

  2. wound cosmesis [ Time Frame: around 2 years ]
    The cosmesis is measure by the length of the incision


Secondary Outcome Measures :
  1. Operative time [ Time Frame: around 2 years ]
    By chart review

  2. Visceral/vascular injuries [ Time Frame: around 2 years ]
    Recorded on the operative note

  3. Conversion [ Time Frame: around 2 years ]
    Recorded on the operative note

  4. Wound infection/surgical site infection [ Time Frame: around 2 years ]
    By chart review

  5. Intra-abdominal collection [ Time Frame: around 2 years ]
    Defined by evidence on any image modalities

  6. Postoperative ileus [ Time Frame: around 2 years ]
    Defined by ileus physically or by image

  7. Length of hospitalization [ Time Frame: around 2 years ]
    By chart review

  8. Time to return work [ Time Frame: around 2 years ]
    By chart review



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198065


Contacts
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Contact: Yu-tso Liao, M.D. 886-972-655-738 Yutsoliao@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yu-tso Liao, M.D.    886-972-655-738    Yutsoliao@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Peng-shen Lai, M.D. National Taiwan University Hospital, Yun-Lin Branch

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03198065     History of Changes
Other Study ID Numbers: 201702076RIND
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Laparoscopic appendectomy
Single-incision laparoscopic appendectomy
Single-incision laparoscopic surgery setting
Simple appendicitis
Complicated appendicitis
Additional relevant MeSH terms:
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Appendicitis
Abdomen, Acute
Surgical Wound
Wounds and Injuries
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive