Incisional Hernia Clinical Trial
Official title:
Total 102 Natural Orifice Specimen Extractions Following Laparoscopic Colorectal Resections
| NCT number | NCT04394988 |
| Other study ID # | 2018/21-41 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2013 |
| Est. completion date | August 1, 2018 |
| Verified date | May 2020 |
| Source | Inonu University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 102 |
| Est. completion date | August 1, 2018 |
| Est. primary completion date | July 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - patients who underwent laparoscopic - natural orifice colectomy. Exclusion Criteria: - patients with missing data - patients who underwent open colectomy |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Inonu University | Malatya |
| Lead Sponsor | Collaborator |
|---|---|
| Inonu University |
Turkey,
Awad 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. — View Citation
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. — View Citation
Karagul 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. — View Citation
Kayaalp 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | complications due to incision and aesthetic score | Hernia, infection, hospital stay and aesthetic score | 6 months |
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