Peritoneal Closure Versus Non Closure During Open Appendectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: open appendectomy with peritoneal closure; Procedure: open appendectomy without peritoneal closure

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34090
    • Bezmialem Vakif University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peritoneal Closure; open appendectomy with peritoneal closure	Procedure: open appendectomy with peritoneal closure; open appendectomy with peritoneal closure under general anesthesia for acute appendicitis
Active Comparator: Peritoneal Non Closure; open appendectomy without peritoneal closure	Procedure: open appendectomy without peritoneal closure; open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Huseyin K Bektasoglu, MD, Bezmialem Vakif University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: postoperative pain; life quality; appendectomy; peritoneal closure
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: 16_12_2015-23/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided