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Peritoneal Closure Versus Non Closure During Open Appendectomy

NCT ID: NCT02803463

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-12-31

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.

Conditions

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Acute Appendicitis

Keywords

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peritoneal closure appendectomy postoperative pain life quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Peritoneal Closure

open appendectomy with peritoneal closure

Group Type ACTIVE_COMPARATOR

open appendectomy with peritoneal closure

Intervention Type PROCEDURE

open appendectomy with peritoneal closure under general anesthesia for acute appendicitis

Peritoneal Non Closure

open appendectomy without peritoneal closure

Group Type ACTIVE_COMPARATOR

open appendectomy without peritoneal closure

Intervention Type PROCEDURE

open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

Interventions

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open appendectomy with peritoneal closure

open appendectomy with peritoneal closure under general anesthesia for acute appendicitis

Intervention Type PROCEDURE

open appendectomy without peritoneal closure

open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huseyin K Bektasoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University, Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 31249637 (View on PubMed)

Other Identifiers

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16_12_2015-23/14

Identifier Type: -

Identifier Source: org_study_id