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Status unknownNCT01458353Updated Oct 24, 2011

Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer

A Phase 3 interventional study of Stapled anastomosis and Handsewn anastomosis in Peritoneal Contamination After Ileocolonic Anastomosis, Wound Infection and Intra-abdominal Abscess, sponsored by Hospital General Universitario Elche. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2011-10-24.

Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study summary

Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the suture is performed.

Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than after handsewn ones.

02

Conditions studied

  • Peritoneal Contamination After Ileocolonic Anastomosis
  • Wound Infection
  • Intra-abdominal Abscess

Keywords

  • Right-sided colon cancer
  • Ileocolonic anastomosis
  • stapled anastomosis
  • handsewn anastomosis
  • peritoneal contamination
  • microbiological spectrum
03

In context

Wound Infection

270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.

This study's planned enrollment of 80 is below the median of 141 across 228 interventional studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Hospital General Universitario Elche is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Handsewn ileocolonic anastomosis

    Swabs obtained from patients undergoing handsewn ileocolonic anastomosis

    Procedure: Handsewn anastomosis

  • Experimental
    Stapled ileocolonic anastomosis

    Swabs obtained for culture in those patients undergoing stapled ileocolonic anastomosis

    Procedure: Stapled anastomosis

Interventions

  • ProcedureStapled anastomosis

    Stapled anastomosis after ileocolonic resection

  • ProcedureHandsewn anastomosis

    Handsewn anastomosis after ileocolonic resection

06

What researchers measure

Primary outcomes

  1. Peritoneal contamination after finishing the ileocolonic anastomosis

    Swabs will be obtained from the peritoneal surface for microbiological culture

    Time frame: 1 year

07

Study locations

1 site
  • Hospital General de Elche
    Elche, Alicante 03202, Spain
08

References and documents

Publications

  • Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Lopez A, Frangi A, Armananzas L, Alcaide MJ, Candela F, Calpena R. Microbiological spectrum of the intraperitoneal surface after elective right-sided colon cancer: are there differences in the peritoneal contamination after performing a stapled or a handsewn anastomosis? Int J Colorectal Dis. 2012 Nov;27(11):1515-9. doi: 10.1007/s00384-012-1492-9. Epub 2012 May 12. PubMed 22581209 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01458353
Lead sponsor
Hospital General Universitario Elche
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Doctor in Surgery by Universidad Autonoma de Madrid (Spain), Hospital General Universitario Elche) — Principal investigator
First posted
Oct 24, 2011
Start date
Nov 2011
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Oct 24, 2011

Study contacts

Jaime Jaime, MD, PhD
Contact
jruiztovar@gmail.com
(0034)630534808
Jaime Ruiz-Tovar, MD, PhD
principal investigator · Hospital General de Elche
Antonio Arroyo, MD, PhD
study director · Hospital General de Elche

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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