A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

Laparoscopic Entry Technique Clinical Trial

Official title:

A Comparison of Three Different Puncture Points to Establish the Pneumoperitoneum in Laparoscopic Gastrointestinal Surgery: A Randomized Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804529
• Other study ID #: ChinaJapanFH Meng001
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2016
• Last updated: February 8, 2018
• Start date: July 2016
• Est. completion date: September 2018

Study information

• Verified date: February 2018
• Source: China-Japan Friendship Hospital
• Contact: Fangqiang Meng, MD,CSCRS
• Phone: 861084206168
• Email: mengfq75[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Palmer's point and periumbilical region are the common laparoscopic entry site to establish the pneumoperitoneum. In the present study, the investigators assess the safety and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the gastrointestinal surgery.

This prospective and randomized study will compare the three entry techniques with regard to:

• Complications related to the entry technique

• Time taken to enter the abdomen.

• The number of attempts taken to enter the abdomen

Description:

Patients of China-Japan Friendship Hospital that are having a laparoscopic surgery for general surgery purposes will participate in the study. Patients with previous abdominal surgeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the three arms of the trial. All patient information will be confidential and only be available to researches involved in the study. Only one attending surgeon of the General Surgery Department of China-Japan Friendship Hospital will participate in the study. 90 patients will be recruited over one year period and the data will be analysed by a statistician.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any patient suitable for laparoscopic abdominal surgery

Exclusion Criteria:

• previous abdominal surgeries

Related Conditions & MeSH terms

• Laparoscopic Entry Technique
• Pneumoperitoneum

Intervention

Device:
• Veress needle

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Ahmad G, Gent D, Henderson D, O'Flynn H, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2015 Aug 31;8:CD006583. doi: 10.1002/14651858.CD006583.pub4. Review. — View Citation

Angioli R, Terranova C, De Cicco Nardone C, Cafà EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23. — View Citation

Granata M, Tsimpanakos I, Moeity F, Magos A. Are we underutilizing Palmer's point entry in gynecologic laparoscopy? Fertil Steril. 2010 Dec;94(7):2716-9. doi: 10.1016/j.fertnstert.2010.03.055. Epub 2010 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications during entry in laparoscopy		During surgery
Secondary	Time to enter in the abdominal cavity		During surgery