Warm and Humidified vs Cold and Dry Carbon Dioxide (CO2) Pneumoperitoneum

NCT03330067 | Withdrawn FDA Device

• 1 other identifier: GCO 16-2223
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery (surgery with the use of a camera and small instruments) uses insufflation, which is the standard medical practice where CO2 (carbon dioxide) gas is blown into the abdomen to create space for surgical procedures. The purpose of this study is to investigate whether heating and humidifying surgical CO2 will reduce surgery-related inflammation and postoperative pain.

Conditions

Pneumoperitoneum

Keywords

laparoscope

Outcome Measures

Primary Outcomes (2)

• Number of pain medications taken postoperatively

  The number of pain medications administered while hospitalized postoperatively will be tracked and recorded.

  up to 7 days

• Timing of pain medications taken postoperatively

  The timing of pain medications administered while hospitalized postoperatively will be tracked and recorded.

  up to 7 days

Secondary Outcomes (12)

• Postoperative pain levels

  up to 21 days

• Number of pain medications taken after discharge

  up to 21 days

• Intraoperative narcotic use

  Day 1

• Analgesia requirements in the post anesthesia care unit

  Day 1

• Volume of CO2 consumed during surgery

  Day 1

Study Arms (2)

Cold and dry CO2 pneumoperitoneum

SHAM COMPARATOR

Pneumoperitoneum is created by insufflation of standard cold (19-21°C) and nonhumidified (0%) CO2 directly from a standard CO2 tank or wall source.

Device: Cold and dry CO2 pneumoperitoneum

Warm and humidified CO2 pneumoperitoneum

EXPERIMENTAL

The humidification and warming device to be used is the Insuflow Synergy Port (Lexion Company, FDA approved) which is a specialized 5 mm port that delivers warmed (95° F) and humidified (95% relative humidity) CO2, the source of which is a standard CO2 tank or wall source.

Device: Warm and humidified CO2 pneumoperitoneum

Interventions

Cold and dry CO2 pneumoperitoneum DEVICE

In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.

Cold and dry CO2 pneumoperitoneum

Warm and humidified CO2 pneumoperitoneum DEVICE

In this arm, patients undergo pneumoperitoneum by the insufflation of warmed (95° F) and humidified (95% relative humidity) CO2, using a Lexion Insuflow device.

Also known as: Lexion Insuflow device

Warm and humidified CO2 pneumoperitoneum

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective laparoscopic colorectal resection (LCR) for all indications (cancer, diverticular disease, benign neoplasm, inflammatory bowel disease, etc)

You may not qualify if:

• Patients younger than 18 and older than 85, emergency surgery, reoperation within 30 days, patients who are taking pain medications (either NSAID's or narcotics) on a daily basis preoperatively for whatever reason, patients with a history of narcotics addiction, paraplegic and quadriplegic patients, patients with dementia or altered mental status, and patients on steroids.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Mount Sinai West Hospital

New York, New York, 10019, United States

Location

Related Publications (14)

• Neuhaus SJ, Gupta A, Watson DI. Helium and other alternative insufflation gases for laparoscopy. Surg Endosc. 2001 Jun;15(6):553-60. doi: 10.1007/s004640080060. Epub 2001 Apr 3.

  PMID: 11591939 BACKGROUND

• Brokelman WJ, Lensvelt M, Borel Rinkes IH, Klinkenbijl JH, Reijnen MM. Peritoneal changes due to laparoscopic surgery. Surg Endosc. 2011 Jan;25(1):1-9. doi: 10.1007/s00464-010-1139-2. Epub 2010 Jun 15.

  PMID: 20552372 BACKGROUND

• Erikoglu M, Yol S, Avunduk MC, Erdemli E, Can A. Electron-microscopic alterations of the peritoneum after both cold and heated carbon dioxide pneumoperitoneum. J Surg Res. 2005 May 1;125(1):73-7. doi: 10.1016/j.jss.2004.11.029.

  PMID: 15836853 BACKGROUND

• Holmdahl L, Ivarsson ML. The role of cytokines, coagulation, and fibrinolysis in peritoneal tissue repair. Eur J Surg. 1999 Nov;165(11):1012-9. doi: 10.1080/110241599750007810.

  PMID: 10595602 BACKGROUND

• Almeida OD Jr. Awake microlaparoscopy with the Insuflow device. JSLS. 2002 Jul-Sep;6(3):199-201.

  PMID: 12166755 BACKGROUND

• Demco L. Effect of heating and humidifying gas on patients undergoing awake laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):247-51. doi: 10.1016/s1074-3804(05)60585-3.

  PMID: 11342732 BACKGROUND

• Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.

  PMID: 1688289 BACKGROUND

• Braga M, Vignali A, Gianotti L, Zuliani W, Radaelli G, Gruarin P, Dellabona P, Di Carlo V. Laparoscopic versus open colorectal surgery: a randomized trial on short-term outcome. Ann Surg. 2002 Dec;236(6):759-66; disscussion 767. doi: 10.1097/01.SLA.0000036269.60340.AE.

  PMID: 12454514 BACKGROUND

• Chen HH, Wexner SD, Weiss EG, Nogueras JJ, Alabaz O, Iroatulam AJ, Nessim A, Joo JS. Laparoscopic colectomy for benign colorectal disease is associated with a significant reduction in disability as compared with laparotomy. Surg Endosc. 1998 Dec;12(12):1397-400. doi: 10.1007/s004649900867.

  PMID: 9822465 BACKGROUND

• Franklin ME Jr, Rosenthal D, Abrego-Medina D, Dorman JP, Glass JL, Norem R, Diaz A. Prospective comparison of open vs. laparoscopic colon surgery for carcinoma. Five-year results. Dis Colon Rectum. 1996 Oct;39(10 Suppl):S35-46. doi: 10.1007/BF02053804.

  PMID: 8831545 BACKGROUND

• Franklin ME Jr, Rosenthal D, Norem RF. Prospective evaluation of laparoscopic colon resection versus open colon resection for adenocarcinoma. A multicenter study. Surg Endosc. 1995 Jul;9(7):811-6. doi: 10.1007/BF00190088.

  PMID: 7482191 BACKGROUND

• Schwenk W, Bohm B, Muller JM. Postoperative pain and fatigue after laparoscopic or conventional colorectal resections. A prospective randomized trial. Surg Endosc. 1998 Sep;12(9):1131-6. doi: 10.1007/s004649900799.

  PMID: 9716766 BACKGROUND

• Birch DW, Manouchehri N, Shi X, Hadi G, Karmali S. Heated CO(2) with or without humidification for minimally invasive abdominal surgery. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD007821. doi: 10.1002/14651858.CD007821.pub2.

  PMID: 21249696 BACKGROUND

• Ott DE, Reich H, Love B, McCorvey R, Toledo A, Liu CY, Syed R, Kumar K. Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study. JSLS. 1998 Oct-Dec;2(4):321-9.

  PMID: 10036122 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Richard Whelan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before surgery patients will be assigned to one of two types of CO2 gas (conventional-room temperature and dry, or conditioned-95°F and 95% humidity) by a method similar to the flip of a coin.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: January 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2025
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)