Predictive Factors of Conversion in Laparoscopic Colorectal Cancer Resection

NCT ID: NCT04589975

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

829 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2018-12-31

Brief Summary

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Background Laparoscopic resection is the treatment of choice for colorectal cancer. Rates of conversion to open surgery range between 7% and 30% and controversy exists as to the effect of this on oncologic outcomes. The objective of this study was to analyze what factors are predictive of conversion and what effect they have on oncologic outcomes.

Material \& Methods From a prospective database of patients undergoing laparoscopic surgery between 2000 and 2018 a uni- and multivariate analyses were made of demographic, pathological and surgical variables together with complementary treatments comparing purely laparoscopic resection with conversions to open surgery. Overall and disease-free survival were compared using the Kaplan-Meier method.

Detailed Description

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Laparoscopic resection of colorectal cancer is the surgical option of choice provided that established oncologic principles are guaranteed \[1-4\].

Apart from the well-known advantages of minimally invasive surgery (shorter hospital stays, lower pain levels, faster return of bowel functions and rapid return to normal daily activities) reductions in operative morbidity and mortality have been reported together with oncologic outcomes which are similar to those of open surgery \[5-7\].

However, reported conversion rates to open surgery are highly variable (7% - 30%) as is the impact of conversion on oncologic outcomes \[8-10\]). The objectives of this study were to identify the risk factors associated with conversion and to assess their impact on operative morbidity and mortality and long-term oncologic outcomes.

Conditions

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Surgery Colorectal Neoplasm Laparoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All laparoscopic colorectal neoplasia, laparoscopic resected

Exclusion Criteria

* Palliative and emergency procedures
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.

Reference Type BACKGROUND
PMID: 19071061 (View on PubMed)

Fleshman J, Sargent DJ, Green E, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Nelson H; Clinical Outcomes of Surgical Therapy Study Group. Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg. 2007 Oct;246(4):655-62; discussion 662-4. doi: 10.1097/SLA.0b013e318155a762.

Reference Type BACKGROUND
PMID: 17893502 (View on PubMed)

Allaix ME, Furnee E, Esposito L, Mistrangelo M, Rebecchi F, Arezzo A, Morino M. Analysis of Early and Long-Term Oncologic Outcomes After Converted Laparoscopic Resection Compared to Primary Open Surgery for Rectal Cancer. World J Surg. 2018 Oct;42(10):3405-3414. doi: 10.1007/s00268-018-4614-x.

Reference Type BACKGROUND
PMID: 29610930 (View on PubMed)

de Neree Tot Babberich MPM, van Groningen JT, Dekker E, Wiggers T, Wouters MWJM, Bemelman WA, Tanis PJ; Dutch Surgical Colorectal Audit. Laparoscopic conversion in colorectal cancer surgery; is there any improvement over time at a population level? Surg Endosc. 2018 Jul;32(7):3234-3246. doi: 10.1007/s00464-018-6042-2. Epub 2018 Jan 17.

Reference Type BACKGROUND
PMID: 29344789 (View on PubMed)

Related Links

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http://www.sages.org/publications/guidelines/guidelines

Society of American Gastrointestinal and and Endoscopic Surgeons, Guidelines for Laparoscopic resection of curable colon and rectal cancer, Guidelines. (2015)

Other Identifiers

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PFLC

Identifier Type: -

Identifier Source: org_study_id

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