NCT02543853

Brief Summary

The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

May 24, 2015

Last Update Submit

September 4, 2015

Conditions

Gastrointestinal Disorder Postoperative

Outcome Measures

Primary Outcomes (1)

  • Bowel sound (first bowel sound)

    time from surgery to first bowel sound as hours

    Postoperative first 72 hours

Secondary Outcomes (1)

  • Gas discharge

    Postoperative first 72 hours

Study Arms (2)

veres needle entry arm

ACTIVE COMPARATOR

Vere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared

Other: veres needle entry

direct trocar entry arm

ACTIVE COMPARATOR

Direct trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared

Other: direct trocar entry

Interventions

direct trocar entryOTHER

direct trocar entry to provide pneumoperitoneum

direct trocar entry arm
veres needle entryOTHER

veres needle entry to provide pneumoperitoneum

veres needle entry arm

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic surgery for benign or malignant disease

You may not qualify if:

  • Patients with gastrointestinal intervention
  • Patients who had undergone previous operations
  • Patients with gastrointestinal intervention dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Compeau C, McLeod NT, Ternamian A. Laparoscopic entry: a review of Canadian general surgical practice. Can J Surg. 2011 Oct;54(5):315-20. doi: 10.1503/cjs.011210.

    PMID: 21774882BACKGROUND

  • Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.

    PMID: 20124777BACKGROUND

  • Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.

    PMID: 22336819RESULT

Central Study Contacts

Enis Ozkaya, md

CONTACT

905054742459enozkaya1979@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 24, 2015

First Posted

September 7, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

TU(1)