Acute AppendicitisNCT02803463
Peritoneal Closure Versus Non Closure During Open Appendectomy
A study testing open appendectomy with peritoneal closure and open appendectomy without peritoneal closure in people with Acute Appendicitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- open appendectomy with peritoneal closure and open appendectomy without peritoneal closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute appendicitis
- age between 18-65 years
Who cannot join
- preoperatively diagnosed intraabdominal abcess
- intraoperatively diagnosed free purulent fluid in abdominal cavity
- pregnancy
- malignancy history
- mental retardation
- chronical renal failure
Show all 9Show fewer
- chronical liver disease
- diabetes mellitus
- patients' denial of participation to study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Faculty of Medicine
Istanbul, 34090
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Appendicitis
- Being tested
- open appendectomy with peritoneal closure, open appendectomy without peritoneal closure
- Keywords
- peritoneal closure, appendectomy, postoperative pain, life quality
- Medical subject headings
- Appendicitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open appendectomy with peritoneal closureProcedure or surgery
open appendectomy with peritoneal closure under general anesthesia for acute appendicitis
open appendectomy without peritoneal closureProcedure or surgery
open appendectomy without peritoneal closure under general anesthesia for acute appendicitis
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Closure | Active comparator | open appendectomy with peritoneal closure Receives: Procedure: open appendectomy with peritoneal closure |
| Peritoneal Non Closure | Active comparator | open appendectomy without peritoneal closure Receives: Procedure: open appendectomy without peritoneal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score
visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.
Measured: postoperative day 1
Surgical Site Infection
Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess
Measured: postoperative 30 days
Life Quality Score
Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th
Measured: postoperative day 10
Secondary outcomes (3)
operation time
time from beginning of incision to closure of incision
Measured: intraoperatively
wound dehiscence
fascial dehiscence during postoperative 30 days diagnosed via physical examination of sonography.
Measured: postoperative 30 days
postoperative mortality
mortality in postoperative 30 days
Measured: postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huseyin K Bektasoglu, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803463
- Sponsor's protocol ID
- 16_12_2015-23/14
- Status last verified
- Dec 2016
- First submitted
- 14 Jun 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 31249637
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Closure Versus Non Closure During Open Appendectomy: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02803463
- Acronym / sponsor ID
- 16_12_2015-23/14
- Conditions
- Acute Appendicitis
- Keywords
- peritoneal closure, appendectomy, postoperative pain, life quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Closure | Active comparator | Procedure: open appendectomy with peritoneal closureopen appendectomy with peritoneal closure |
| Peritoneal Non Closure | Active comparator | Procedure: open appendectomy without peritoneal closureopen appendectomy without peritoneal closure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with acute appendicitis
- age between 18-65 years
Key exclusion criteria (9 listed)
- preoperatively diagnosed intraabdominal abcess
- intraoperatively diagnosed free purulent fluid in abdominal cavity
- pregnancy
- malignancy history
- mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open appendectomy with peritoneal closureopen appendectomy with peritoneal closure under general anesthesia for acute appendicitis | Procedure or surgery | Peritoneal Closure |
| open appendectomy without peritoneal closureopen appendectomy without peritoneal closure under general anesthesia for acute appendicitis | Procedure or surgery | Peritoneal Non Closure |
Primary outcome
Visual analogue pain score
Time frame: postoperative day 1
visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.
Surgical Site Infection
Time frame: postoperative 30 days
Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess
Life Quality Score
Time frame: postoperative day 10
Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th
3 secondary outcomes
operation time
Time frame: intraoperatively
wound dehiscence
Time frame: postoperative 30 days
postoperative mortality
Time frame: postoperative 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Derived from this study: PubMed 31249637Bektasoglu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huseyin K Bektasoglu, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open appendectomy with peritoneal closure and open appendectomy without peritoneal closure in people with Acute Appendicitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain score (time frame: postoperative day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.