The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

Gastrointestinal Disorder Postoperative Clinical Trial

Official title:

The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543853
• Other study ID #: 990902
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2015
• Last updated: September 4, 2015
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: Enis Ozkaya, md
• Phone: 905054742459
• Email: enozkaya1979[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Laparoscopic surgery for benign or malignant disease

Exclusion Criteria:

• Patients with gastrointestinal intervention

• Patients who had undergone previous operations

• Patients with gastrointestinal intervention dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Disorder Postoperative

Intervention

Other:
• direct trocar entry
direct trocar entry to provide pneumoperitoneum
• veres needle entry
veres needle entry to provide pneumoperitoneum

Locations

Country	Name	City	State
Turkey	Zeynep Kamil	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel sound (first bowel sound)	time from surgery to first bowel sound as hours	Postoperative first 72 hours	Yes
Secondary	Gas discharge	time from surgery to first bowel sound as hours	Postoperative first 72 hours	Yes