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

Warm and Humidified vs Cold and Dry Dry Carbon Dioxide (CO2) Pneumoperitoneum in Minimally Invasive Colorectal Resection: A Randomized Controlled Trial and Study of Clinical Endpoints

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.

Study Overview

• Status: Withdrawn
• Conditions: Pneumoperitoneum
• Intervention / Treatment: Device: Cold and dry CO2 pneumoperitoneum; Device: Warm and humidified CO2 pneumoperitoneum

Detailed Description

This is a prospective, randomized controlled trial in which 120 patients undergoing elective laparoscopic colorectal resection will either undergo insufflation of the peritoneum with cold and dry (CD), control or warm and humidified (WH) CO2, experimental. Patients scheduled to undergo elective Laparoscopic Colon Resection (LCR) will be informed about the study and all questions answered. Consenting patients will be randomized (via envelope system) to have either standard cold (19-21°C) and nonhumidified (0%) CO2 or warm (37°C) and humidified (95%) CO2 utilized for their resection. To ensure that similar numbers of rectal resection patients are in each group, a separate envelop randomization will be used for colectomy and rectal resection cases.

The study will be conducted at Mount Sinai West hospital. The ambient operating room temperature will be regulated to 70-72° F. All patients will undergo laparoscopic surgery. During laparoscopic surgery the camera and instruments are inserted into the abdomen via small incisions allowing for the surgeon to explore the whole abdominal cavity without making larger cuts. In order to create space for surgical procedures, insufflation with CO2 is used. Regarding the method of insufflation, subjects will be randomized into 2 groups: i) standard CD CO2 insufflation ii) Lexion Insuflow device providing warmed humidified CO2 insufflation (95° F and 95% relative humidity) 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. This study was conceived and designed by the PI who approached Lexion seeking devices for the study. The company will provide no funds for the study and the data and all decision regarding presentation and publications are to be made by Mount Sinai West research team.

Study patients will receive anesthesia according to the following regimen (Mount Sinai West anesthesia department has suggested this regimen and has agreed to abide by it for LCR patients unless there is a contraindication to this approach in a given patient): Induction anesthesia will include IV midazolam, IV fentanyl (3-5 mcg/kg), IV propofol, IV rocuronium, perioperative IV antibiotics, IV ondansetron for nausea prophylaxis, IV dexamethasone (8mg), IV acetaminophen 1000mg, and IV ketorolac 15 mg. Maintenance anesthesia will included IV fentanyl (1-2 mcg/kg/hr), sevoflurane or desflurane inhalational agent, and 100% oxygen. Fentanyl doses can be increased at the discretion of the anesthesiologist. 30-40 minutes before the end of the procedure, the intraoperative narcotics will be discontinued and hydromorphone PCA will be started. Patients will receive hydromorphone in the post anesthesia care unit according to the discretion of the anesthesiologist.

Analysis: Data will be recorded by the Study RN and/or the research resident on a daily basis on Case Report Forms (paper) which will be entered into a HIPPA compliant dedicated study data base with access limited to study personnel and our data manager. The Non-parametric and parametric tests such as Kruskal-Wallis test and Analysis of Variance test shall be used to determine the impact of warm humidified vs cold dry CO2 on postoperative pain medication requirements as well as on other operative and short term clinical outcomes.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Cold and dry CO2 pneumoperitoneum; 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; In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.
Experimental: Warm and humidified CO2 pneumoperitoneum; 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; In this arm, patients undergo pneumoperitoneum by the insufflation of warmed (95° F) and humidified (95% relative humidity) CO2, using a Lexion Insuflow device.; Other Names: Lexion Insuflow device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain levels	Postoperatively, pain levels (visual analog hospital pain scale) will be measured and recorded. scale from no pain (0) to worse pain (10).	up to 21 days
Number of pain medications taken after discharge	Patients will likewise record the type and 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	CO2 gas volumes required for LCR	Day 1
Length of stay		up to 21 days
Time to first flatus		up to 21 days
Time to first bowel movement		up to 21 days
Time to solid diet		up to 21 days
Postoperative complications		up to 21 days
Duration of Surgery		Day 1
Incision length		Day 1

Collaborators and Investigators

• Sponsor: Northwell Health

Publications and helpful links

General Publications

• Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
• 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.
• 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.
• 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.
• 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.
• Almeida OD Jr. Awake microlaparoscopy with the Insuflow device. JSLS. 2002 Jul-Sep;6(3):199-201.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: laparoscope
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: GCO 16-2223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes