Peritoneal Closure Versus Non Closure During Open Appendectomy

Not Applicable

Completed

• Conditions: Acute Appendicitis
• Interventions: Procedure: open appendectomy without peritoneal closure; Procedure: open appendectomy with peritoneal closure

• Registration Number: NCT02803463
• Lead Sponsor: Bezmialem Vakif University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peritoneal Non Closure	open appendectomy without peritoneal closure	open appendectomy without peritoneal closure
Peritoneal Closure	open appendectomy with peritoneal closure	open appendectomy with peritoneal closure

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bezmialem Vakif University, Faculty of Medicine; 🇹🇷 Istanbul, Turkey