Peritoneal Closure Versus Non Closure During Open Appendectomy

Acute Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803463
• Other study ID #: 16_12_2015-23/14
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: December 15, 2016
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• open appendectomy with peritoneal closure
open appendectomy with peritoneal closure under general anesthesia for acute appendicitis
• open appendectomy without peritoneal closure
open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University, Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue pain score	visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.	postoperative day 1	No
Primary	Surgical Site Infection	Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess	postoperative 30 days	No
Primary	Life Quality Score	Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th	postoperative day 10	No
Secondary	operation time	time from beginning of incision to closure of incision	intraoperatively	No
Secondary	wound dehiscence	fascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography.	postoperative 30 days	No
Secondary	postoperative mortality	mortality in postoperative 30 days	postoperative 30 days	No