Clinical trial NCT02804529: A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum
Official title: A Comparison of Three Different Puncture Points to Establish the Pneumoperitoneum in Laparoscopic Gastrointestinal Surgery: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Entry Technique
Keywords: Laparoscopic entry
Meng's point
Veress needle
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Any patient suitable for laparoscopic abdominal surgery

Exclusion Criteria:

* previous abdominal surgeries

Primary outcomes:
measure: Complications during entry in laparoscopy
timeFrame: During surgery
Secondary outcomes:
measure: Time to enter in the abdominal cavity
timeFrame: During surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Fanqiang Meng, MD,CSCRS
role: STUDY_DIRECTOR
References:
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.
citation: Angioli R, Terranova C, De Cicco Nardone C, Cafa 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.
citation: 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.