Single-incision Laparoscopic Surgery in Acute Abdomen

NCT ID: NCT03198065

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-17

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Acute Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hand-made glove setting

The patients receive Hand-made glove setting

Group Type EXPERIMENTAL

Hand-made glove setting

Intervention Type PROCEDURE

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

commercialized multiport setting

The patients receive commercialized single-incision multiport setting

Group Type EXPERIMENTAL

Commercialized single-incision multiport setting

Intervention Type PROCEDURE

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

Interventions

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Hand-made glove setting

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

Intervention Type PROCEDURE

Commercialized single-incision multiport setting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peng-shen Lai, M.D.

Role: STUDY_DIRECTOR

National Taiwan University Hospital, Yun-Lin Branch

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-tso Liao, M.D.

Role: CONTACT

886-972-655-738

Facility Contacts

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Yu-tso Liao, M.D.

Role: primary

886-972-655-738

Other Identifiers

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201702076RIND

Identifier Type: -

Identifier Source: org_study_id

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