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Peritoneal Closure Versus Non Closure During Open Appendectomy

Primary Purpose

Acute Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
open appendectomy with peritoneal closure
open appendectomy without peritoneal closure
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis focused on measuring peritoneal closure, appendectomy, postoperative pain, life quality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with acute appendicitis
  • age between 18-65 years

Exclusion Criteria:

  • preoperatively diagnosed intraabdominal abcess
  • intraoperatively diagnosed free purulent fluid in abdominal cavity
  • pregnancy
  • malignancy history
  • mental retardation
  • chronical renal failure
  • chronical liver disease
  • diabetes mellitus
  • patients' denial of participation to study

Sites / Locations

  • Bezmialem Vakif University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Peritoneal Closure

Peritoneal Non Closure

Arm Description

open appendectomy with peritoneal closure

open appendectomy without peritoneal closure

Outcomes

Primary Outcome Measures

Visual analogue pain score
visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.
Surgical Site Infection
Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess
Life Quality Score
Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th

Secondary Outcome Measures

operation time
time from beginning of incision to closure of incision
wound dehiscence
fascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography.
postoperative mortality
mortality in postoperative 30 days

Full Information

First Posted
June 14, 2016
Last Updated
December 15, 2016
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT02803463
Brief Title
Peritoneal Closure Versus Non Closure During Open Appendectomy
Official Title
Peritoneal Closure Versus Non Closure During Open Appendectomy: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There has been no consensus over closure versus non closure of peritoneum during abdominal operations. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.
Detailed Description
There has been no consensus over closure versus non closure of peritoneum during abdominal operations. in literature, few reports suggested that peritoneal closure may prolong the operation time, may increase the costs and has a probable aggravating effect on postoperative pain. In addition, there have been some reports that suggest non closure of peritoneum may not increase the postoperative complications. The need of further studies to clarify the effect of peritoneal closure versus non closure on postoperative pain and life quality especially has been specified in some literature. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
Keywords
peritoneal closure, appendectomy, postoperative pain, life quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peritoneal Closure
Arm Type
Active Comparator
Arm Description
open appendectomy with peritoneal closure
Arm Title
Peritoneal Non Closure
Arm Type
Active Comparator
Arm Description
open appendectomy without peritoneal closure
Intervention Type
Procedure
Intervention Name(s)
open appendectomy with peritoneal closure
Intervention Description
open appendectomy with peritoneal closure under general anesthesia for acute appendicitis
Intervention Type
Procedure
Intervention Name(s)
open appendectomy without peritoneal closure
Intervention Description
open appendectomy without peritoneal closure under general anesthesia for acute appendicitis
Primary Outcome Measure Information:
Title
Visual analogue pain score
Description
visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.
Time Frame
postoperative day 1
Title
Surgical Site Infection
Description
Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess
Time Frame
postoperative 30 days
Title
Life Quality Score
Description
Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th
Time Frame
postoperative day 10
Secondary Outcome Measure Information:
Title
operation time
Description
time from beginning of incision to closure of incision
Time Frame
intraoperatively
Title
wound dehiscence
Description
fascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography.
Time Frame
postoperative 30 days
Title
postoperative mortality
Description
mortality in postoperative 30 days
Time Frame
postoperative 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with acute appendicitis age between 18-65 years Exclusion Criteria: preoperatively diagnosed intraabdominal abcess intraoperatively diagnosed free purulent fluid in abdominal cavity pregnancy malignancy history mental retardation chronical renal failure chronical liver disease diabetes mellitus patients' denial of participation to study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin K Bektasoglu, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University, Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31249637
Citation
Bektasoglu HK, Hasbahceci M, Yigman S, Yardimci E, Kunduz E, Malya FU. Nonclosure of the Peritoneum during Appendectomy May Cause Less Postoperative Pain: A Randomized, Double-Blind Study. Pain Res Manag. 2019 May 23;2019:9392780. doi: 10.1155/2019/9392780. eCollection 2019.
Results Reference
derived

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Peritoneal Closure Versus Non Closure During Open Appendectomy

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