Peritoneal Closure Versus Non Closure During Open Appendectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peritoneal Closure Versus Non Closure During Open Appendectomy: a Randomized Trial

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: open appendectomy with peritoneal closure
* Procedure: open appendectomy without peritoneal closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peritoneal Closure<br>open appendectomy with peritoneal closure | Procedure: open appendectomy with peritoneal closure<br>* open appendectomy with peritoneal closure under general anesthesia for acute appendicitis<br>|
| Active Comparator: Peritoneal Non Closure<br>open appendectomy without peritoneal closure | Procedure: open appendectomy without peritoneal closure<br>* open appendectomy without peritoneal closure under general anesthesia for acute appendicitis<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | time from beginning of incision to closure of incision | intraoperatively | 
| wound dehiscence | fascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography. | postoperative 30 days | 
| postoperative mortality | mortality in postoperative 30 days | postoperative 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal closure, appendectomy, postoperative pain, life quality