Incisional HerniaNCT04394988
Total 102 Natural Orifice Specimen Extractions Following Laparoscopic Colorectal Resections
An observational study of Incisional Hernia and Incision Infection, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
In the development of surgical technique, laparoscopic surgery has created a major breaking point. Although laparoscopy (decreased hospital stay, decreased incisional hernia and wound infection rate…) provides a remarkable advantage compared to open surgery, the need for the extraction site incision could not bring… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incisional Hernia, Incision Infection
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2013to 1 Aug 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent laparoscopic-natural orifice colectomy at General Surgery Clinic in Inonu University between January 2013 and July 2018
Who may be able to join
- patients who underwent laparoscopic - natural orifice colectomy.
Who cannot join
- patients with missing data
- patients who underwent open colectomy
Trial locations and contacts
1 site in 1 country.
About this study
In the development of surgical technique, laparoscopic surgery has created a major breaking point. Although laparoscopy (decreased hospital stay, decreased incisional hernia and wound infection rate…) provides a remarkable advantage compared to open surgery, the need for the extraction site incision could not bring the incision-related morbidity rates to the desired level. That's why SILS and natural hole surgery came to the fore. Colorectal surgery was also affected by this process, and the laparoscopic colectomy procedure combined with transrectal colon extraction was first performed in 1993 (1). Although its use increased gradually after this period, it could not reach the expected levels and this could not resolve the concerns on natural hole surgery.
In this article, our aim is to present the single center results of the patients who performed the extraction with the NOSE method after laparoscopic colorectal surgery.
- Conditions
- Incisional Hernia, Incision Infection
- Keywords
- natural orifice surgery, minimally invasive surgery, colon cancer, laparoscopic colorectal
- Medical subject headings
- Incisional Hernia, Surgical Wound Infection, Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
complications due to incision and aesthetic score
Hernia, infection, hospital stay and aesthetic score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jan 2013
- Primary completion30 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Gündoğan, Inonu University
- Investigators
- Ersin Gundogan, MD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394988
- Sponsor's protocol ID
- 2018/21-41
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gundogan E, Aktas A, Kayaalp C, Gonultas F, Sumer F. Two cases of laparoscopic total colectomy with natural orifice specimen extraction and review of the literature. Wideochir Inne Tech Maloinwazyjne. 2017 Sep;12(3):291-296. doi: 10.5114/wiitm.2017.69227. Epub 2017 Jul 27.
PubMed 29062451Kayaalp C, Kutluturk K, Yagci MA, Ates M. Laparoscopic right-sided colonic resection with transluminal colonoscopic specimen extraction. World J Gastrointest Endosc. 2015 Sep 10;7(12):1078-82. doi: 10.4253/wjge.v7.i12.1078.
PubMed 26380054Karagul S, Kayaalp C, Sumer F, Ertugrul I, Kirmizi S, Tardu A, Yagci MA. Success rate of natural orifice specimen extraction after laparoscopic colorectal resections. Tech Coloproctol. 2017 Apr;21(4):295-300. doi: 10.1007/s10151-017-1611-2. Epub 2017 Apr 26.
PubMed 28447167Awad ZT, Griffin R. Laparoscopic right hemicolectomy: a comparison of natural orifice versus transabdominal specimen extraction. Surg Endosc. 2014 Oct;28(10):2871-6. doi: 10.1007/s00464-014-3540-8. Epub 2014 May 2.
PubMed 24789131Gundogan E, Kayaalp C, Alinak Gundogan G, Sumer F. Total 102 natural orifice specimen extraction following laparoscopic colorectal resections. Updates Surg. 2023 Jan;75(1):197-203. doi: 10.1007/s13304-022-01412-4. Epub 2022 Nov 1.
PubMed 36319790
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total 102 Natural Orifice Specimen Extractions Following Laparoscopic Colorectal Resections
- ClinicalTrials.gov ID
- NCT04394988
- Acronym / sponsor ID
- 2018/21-41
- Conditions
- Incisional Hernia, Incision Infection
- Keywords
- natural orifice surgery, minimally invasive surgery, colon cancer, laparoscopic colorectal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 20 May 2020 (actual)
- 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.
In the development of surgical technique, laparoscopic surgery has created a major breaking point. Although laparoscopy (decreased hospital stay, decreased incisional hernia and wound infection rate…) provides a remarkable advantage compared to open surgery, the need for the extraction site incision could not bring the incision-related morbidity rates to the desired level. That's why SILS and natural hole surgery came to the fore. Colorectal surgery was also affected by this process, and the laparoscopic colectomy procedure combined with transrectal colon extraction was first performed in 1993 (1). Although its use increased gradually after this period, it could not reach the expected levels and this could not resolve the concerns on natural hole surgery.
In this article, our aim is to present the single center results of the patients who performed the extraction with the NOSE method after laparoscopic colorectal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent laparoscopic-natural orifice colectomy at General Surgery Clinic in Inonu University between January 2013 and July 2018
Key inclusion criteria (1 listed)
- patients who underwent laparoscopic - natural orifice colectomy.
Key exclusion criteria (2 listed)
- patients with missing data
- patients who underwent open colectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
complications due to incision and aesthetic score
Time frame: 6 months
Hernia, infection, hospital stay and aesthetic score
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 20 May 2020.
- Background: PubMed 29062451Gundogan E, Aktas A, Kayaalp C, Gonultas F, Sumer F. Two cases of laparoscopic total colectomy with natural orifice specimen extraction and review of the literature. Wideochir Inne Tech Maloinwazyjne. 2017 Sep;12(3):291-296. doi: 10.5114/wiitm.2017.69227. Epub 2017 Jul 27.
- Background: PubMed 26380054Kayaalp C, Kutluturk K, Yagci MA, Ates M. Laparoscopic right-sided colonic resection with transluminal colonoscopic specimen extraction. World J Gastrointest Endosc. 2015 Sep 10;7(12):1078-82. doi: 10.4253/wjge.v7.i12.1078.
- Background: PubMed 28447167Karagul S, Kayaalp C, Sumer F, Ertugrul I, Kirmizi S, Tardu A, Yagci MA. Success rate of natural orifice specimen extraction after laparoscopic colorectal resections. Tech Coloproctol. 2017 Apr;21(4):295-300. doi: 10.1007/s10151-017-1611-2. Epub 2017 Apr 26.
- Background: PubMed 24789131Awad ZT, Griffin R. Laparoscopic right hemicolectomy: a comparison of natural orifice versus transabdominal specimen extraction. Surg Endosc. 2014 Oct;28(10):2871-6. doi: 10.1007/s00464-014-3540-8. Epub 2014 May 2.
- Derived from this study: PubMed 36319790Gundogan E, Kayaalp C, Alinak Gundogan G, Sumer F. Total 102 natural orifice specimen extraction following laparoscopic colorectal resections. Updates Surg. 2023 Jan;75(1):197-203. doi: 10.1007/s13304-022-01412-4. Epub 2022 Nov 1.
- Individual participant dataSharing planned: No
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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.
Ersin Gundogan, MD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia and Incision Infection, run by Inonu 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 1 inclusion and 2 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 20 May 2020. 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?
complications due to incision and aesthetic score (time frame: 6 months). 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 NCT04394988, which also lists 5 linked publications.
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 20 May 2020.