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Single-incision Laparoscopic Surgery in Acute Abdomen

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03198065
Enrollment
30
Registered
2017-06-23
Start date
2017-06-17
Completion date
2019-07-31
Last updated
2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis

Keywords

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

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.

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.

Interventions

PROCEDUREHand-made glove setting

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

PROCEDURECommercialized single-incision multiport setting

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painaround 2 yearsPostoperative pain is measured by visual pain scale
wound cosmesisaround 2 yearsThe cosmesis is measure by the length of the incision

Secondary

MeasureTime frameDescription
Conversionaround 2 yearsRecorded on the operative note
Wound infection/surgical site infectionaround 2 yearsBy chart review
Intra-abdominal collectionaround 2 yearsDefined by evidence on any image modalities
Operative timearound 2 yearsBy chart review
Length of hospitalizationaround 2 yearsBy chart review
Time to return workaround 2 yearsBy chart review
Postoperative ileusaround 2 yearsDefined by ileus physically or by image
Visceral/vascular injuriesaround 2 yearsRecorded on the operative note

Countries

Taiwan

Contacts

Primary ContactYu-tso Liao, M.D.
Yutsoliao@gmail.com886-972-655-738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026