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NCT Number: NCT02803463

Peritoneal Closure Versus Non Closure During Open Appendectomy

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.

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Key information

Conditions

Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University, Faculty of Medicine

Istanbul, 34090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

open appendectomy with peritoneal closure

Procedure

open appendectomy with peritoneal closure under general anesthesia for acute appendicitis

open appendectomy without peritoneal closure

Procedure

open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

Primary outcomes

  1. Visual analogue pain score

    Time frame: postoperative day 1

    visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.

  2. Surgical Site Infection

    Time frame: postoperative 30 days

    Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess

  3. Life Quality Score

    Time frame: postoperative day 10

    Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th

Secondary outcomes

  1. operation time

    Time frame: intraoperatively

    time from beginning of incision to closure of incision

  2. wound dehiscence

    Time frame: postoperative 30 days

    fascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography.

  3. postoperative mortality

    Time frame: postoperative 30 days

    mortality in postoperative 30 days

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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