NCT03499769

Brief Summary

Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Last Updated

July 20, 2018

Status Verified

February 1, 2018

Enrollment Period

5 years

First QC Date

March 27, 2018

Last Update Submit

July 18, 2018

Conditions

Surgical Incision

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Score

    Visual Analog Score for pain (1-10 score)

    240 days

Study Arms (2)

natural orifice

EXPERIMENTAL

Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled

Procedure: natural orifice

conventional

NO INTERVENTION

patients who underwent laparoscopic surgery and removed specimen with conventional will be gathered. demographic data and perioperative results will be compiled. (conventional extraction is suprapubic or median incision)

Interventions

natural orificePROCEDURE

laparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather

Also known as: conventional
natural orifice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • laparoscopic total colectomy patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Natural Orifice Endoscopic SurgeryCongresses as Topic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrganizationsHealth Care Economics and Organizations

Study Officials

  • Ersin Gündoğan

    Inonu Unıversity- general surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
operator doctor

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 17, 2018

Study Start

January 1, 2013

Primary Completion

December 25, 2017

Study Completion

December 28, 2017

Last Updated

July 20, 2018

Record last verified: 2018-02

Locations

TU(1)