Laparoscopic Versus Open Appendectomy

February 21, 2021 updated by: mena helmy, Assiut University

Laparoscopic Versus Open Appendectomy in the Management of Chronic Appendicitis

comparison between laparoscopic and open appendectomy in the management of chronic appendicitis

Study Overview

Status

Not yet recruiting

Detailed Description

The appendix is a blind-ended tube connected to the cecum, from which it develops in the embryo. The most common diseases of the appendix (in humans) are appendicitis and carcinoid tumors. Appendicitis is inflammation of the appendix. Symptoms commonly include right lower abdominal pain, nausea, vomiting, and decreased appetite. However, approximately 40% of people do not have these typical symptoms . Appendicitis is caused by a blockage of the hollow portion of the appendix. This is most commonly due to a calcified "stone" made of feces. Inflamed lymphoid tissue from a viral infection, parasites, gallstone, or tumors may also cause the blockage. This blockage leads to increased pressures in the appendix, decreased blood flow to the tissues of the appendix, and bacterial growth inside the appendix causing inflammation. The combination of inflammation, reduced blood flow to the appendix and distention of the appendix causes tissue injury and tissue death. If this process is left untreated, the appendix may burst, releasing bacteria into the abdominal cavity, leading to increased complications. The surgical procedure for the removal of the appendix is called an appendicectomy. Appendicectomy can be performed through open or laparoscopic surgery. The surgical procedure for the removal of the appendix is called an appendicectomy . Appendicectomy can be performed through open or laparoscopic surgery. When the surgeon uses the open approach, he makes an incision in the lower right section of the abdomen. Most incisions are less than 3 in (7.6 cm) in length. The surgeon then identifies all of the organs in the abdomen and examines them for other disease or abnormalities. The appendix is located and brought up into the wounds. The surgeon separates the appendix from all the surrounding tissue and its attachment to the cecum, and then removes it. The site where the appendix was previously attached, the cecum, is closed and returned to the abdomen The muscle layers and then the skin are sewn together . When the surgeon performs a laparoscopic appendectomy, four incisions, each about 1 in (2.5 cm) in length, are made. One incision is near the umbilicus, or navel, and one is between the umbilicus and the pubis. Two other incisions are smaller and are on the right side of the lower abdomen. The surgeon then passes a camera and special instruments through these incisions. With the aid of this equipment, the surgeon visually examines the abdominal organs and identifies the appendix. The appendix is then freed from all of its attachments and removed. The place where the appendix was formerly attached, the cecum, is stitched. The appendix is removed through one of the incisions. The instruments are removed and then all of the incisions are closed . The primary objective of this study was to compare the laparoscopic approach and the conventional technique in the treatment of chronic Appendicitis.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

clinical diagnosis of chronic appendicitis - - -Male or Female patients with chronic appendicitis

  • Patients who are fit for laparoscopy and general anaeshesia
  • Patients who provide a written informed concent
  • Patient who agree to provide short term outcome data and agree to provide

Exclusion Criteria - - -Patients with severe comorbid conditions with high risk for general anesthesia.

  • Patients suffering from an ongoing infections including chest infections .
  • Patients who didn't give concent .
  • Children and pregnant women
  • Cases of complicated appendicitis .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laparoscopic and open appendectomy
comparative study between laparoscopic and open appendectomy
laparoscopic and open surgery to remove an inflammed appendix in chronic appendicitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assesment of operative time
Time Frame: 1 hour
discover whether open or laparoscopic appendectomy takes longer time
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

November 1, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lap appendectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Inflammation of Appendix

Clinical Trials on laparoscopic and open surgery intervention

3
Subscribe