NCT02803463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

June 14, 2016

Last Update Submit

December 15, 2016

Conditions

Acute Appendicitis

Keywords

peritoneal closureappendectomypostoperative painlife quality

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • operation time

    intraoperatively

  • wound dehiscence

    postoperative 30 days

  • postoperative mortality

    postoperative 30 days

Study Arms (2)

Peritoneal Closure

ACTIVE COMPARATOR

open appendectomy with peritoneal closure

Procedure: open appendectomy with peritoneal closure

Peritoneal Non Closure

ACTIVE COMPARATOR

open appendectomy without peritoneal closure

Procedure: open appendectomy without peritoneal closure

Interventions

open appendectomy with peritoneal closurePROCEDURE

open appendectomy with peritoneal closure under general anesthesia for acute appendicitis

Peritoneal Closure
open appendectomy without peritoneal closurePROCEDURE

open appendectomy without peritoneal closure under general anesthesia for acute appendicitis

Peritoneal Non Closure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University, Faculty of Medicine

Istanbul, 34090, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31249637DERIVED

MeSH Terms

Conditions

AppendicitisPain, Postoperative

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Huseyin K Bektasoglu, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

TU(1)