Comparison the effect of stump closure by endoclips vs endoloop on duration of surgery and complications in patients under laparoscopic appendectomy: A randomized clinical trial
The aim of this study is the survey of effect of stump closure on duration of surgery and complications by endoclips compared with endoloop in patients under laparoscopic appendectomy in Shariati Hospital. The interventional study was carried out as a prospective randomized clinical trial between 2013 and 2015. 76 qualified patients who were clinically diagnosed with acute appendicitis, after obtaining informed consent , randomly were assigned into 2 groups with 38 individuals in each (Randomization was carried out based on the randomized figures obtained from the Blocked-Randomization computer program), then they underwent laparoscopic appendectomy. The exclusion criteria for this research included: patients who were in pain more than 4 days, finding a mass in the RLQ area in the examination, phlegmon in images or peritonitis symptoms also the patients who underwent surgeries which turned into open laparoscopic due to adhesion and improper anatomic conditions were excluded from the study (did not occur in our study). 3 ports were inserted in both groups, two 10-mm ports and one 5-mm port. The mesoappendix was cut with ligasure in both groups and the appendiceal stump was closed with endoclips in one group and with endoloop in the other group and they underwent laparoscopic appendectomy. The surgery duration was calculated from the time the skin was cut until the time it was closed. The patients were then compared regarding the surgery duration, postsurgical symptoms such as pain, wound infection, and leakage from the appendiceal stump, the hospitalization period, and the need for repeating the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507096925N4
Registration date:2015-07-29, 1394/05/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-29, 1394/05/07
Registrant information
Name
Shirzad Nasiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
nasiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of stump closure by endoclips vs endoloop on duration of surgery and complications in patients under laparoscopic appendectomy: A randomized clinical trial
Public title
Comparison the effect of stump closure by endoclips vs endoloop on duration of surgery and complications in patients under laparoscopic appendectomy: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: acute appendicitis.
Exclusion criteria: patients who were in pain more than 4 days; finding a mass in the RLQ area in the examination; phlegmon in images or peritonitis symptoms also the patients who underwent surgeries which turned into open laparoscopic due to adhesion and improper anatomic conditions were excluded from the study (did not occur in our study).
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
6 th Floor, Central Building of Tehran University of Medical Sciences, Gods St., Keshavarz Ave.
City
Tehran
Postal code
Approval date
2013-08-18, 1392/05/27
Ethics committee reference number
1011/130/د/92
Health conditions studied
1
Description of health condition studied
Laparoscopic Appendectomy
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Operative time
Timepoint
From the time the skin was cut until the time it was closed.
Method of measurement
Record in end of the operation's file
Secondary outcomes
1
Description
Surgical site pain
Timepoint
1 day after surgery
Method of measurement
Clinical evaluation and questioning of the patient
2
Description
Wound infection
Timepoint
1 day after surgery
Method of measurement
Patient's record and Clinical evaluation
3
Description
Stump leak
Timepoint
1 day after surgery
Method of measurement
Clinical evaluation
4
Description
Hospital stay
Timepoint
Until the day of discharge from the hospital
Method of measurement
Patient's record
5
Description
Technical complications
Timepoint
Operation day
Method of measurement
Patient's record
Intervention groups
1
Description
Endoloop group: 3 ports were inserted in this group, two 10-mm ports and one 5-mm port. The mesoappendix was cut with ligasure and the appendiceal stump was closed with endoloop and they underwent laparoscopic appendectomy.
Category
Treatment - Surgery
2
Description
Endoclips group: 3 ports were inserted in this group, two 10-mm ports and one 5-mm port. The mesoappendix was cut with ligasure and the appendiceal stump was closed with endoclips and they underwent laparoscopic appendectomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, General Surgery Ward
Full name of responsible person
Dr. Shirzad Nasiri
Street address
General Surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tehran Univesity of Medical Sciences
Full name of responsible person
Office of Research & Technology Management
Street address
6th. floor, Central Organization of Tehran University of Medical Sciences, Quds St.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Tehran Univesity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shirzad Nasiri
Position
Assistant Professor of General Surgery
Other areas of specialty/work
Street address
General Surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
nasiri@razi.tums.ac.ir
Web page address
http://shariati.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shirzad Nasiri
Position
Assistant Professor of General Surgery
Other areas of specialty/work
Street address
General Surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
nasiri@razi.tums.ac.ir
Web page address
shariati.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shirzad Nasiri
Position
Assistant Professor of General Surgery
Other areas of specialty/work
Street address
General surgery Ward, Shariati Hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
nasiri@razi.tums.ac.ir
Web page address
shariati.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)