PneumoperitoneumNCT03330067
Warm and Humidified vs Cold and Dry Carbon Dioxide (CO2) Pneumoperitoneum
A study testing Cold and dry CO2 pneumoperitoneum and Warm and humidified CO2 pneumoperitoneum in people with Pneumoperitoneum, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- Cold and dry CO2 pneumoperitoneum and Warm and humidified CO2 pneumoperitoneum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective laparoscopic colorectal resection (LCR) for all indications (cancer, diverticular disease, benign neoplasm, inflammatory bowel disease, etc)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumoperitoneum
- Being tested
- Cold and dry CO2 pneumoperitoneum, Warm and humidified CO2 pneumoperitoneum
- Keywords
- laparoscope
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold and dry CO2 pneumoperitoneumDevice
In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.
Warm and humidified CO2 pneumoperitoneumDevice
Also called Lexion Insuflow 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Warm and humidified CO2 pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pain medications taken postoperatively
The number of pain medications administered while hospitalized postoperatively will be tracked and recorded.
Measured: up to 7 days
Timing of pain medications taken postoperatively
The timing of pain medications administered while hospitalized postoperatively will be tracked and recorded.
Measured: up to 7 days
Secondary outcomes (12)
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).
Measured: 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.
Measured: up to 21 days
Intraoperative narcotic use
Measured: Day 1
Analgesia requirements in the post anesthesia care unit
Measured: Day 1
Volume of CO2 consumed during surgery
CO2 gas volumes required for LCR
Measured: Day 1
Length of stay
Measured: up to 21 days
Time to first flatus
Measured: up to 21 days
Time to first bowel movement
Measured: up to 21 days
Time to solid diet
Measured: up to 21 days
Postoperative complications
Measured: up to 21 days
Duration of Surgery
Measured: Day 1
Incision length
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startJan 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: We are not performing the study and we don't plan to continue. We do not have support to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Whelan, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330067
- Sponsor's protocol ID
- GCO 16-2223
- Status last verified
- Feb 2023
- First submitted
- 31 Oct 2017
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11591939Brokelman 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.
PubMed 20552372Erikoglu 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.
PubMed 15836853Holmdahl 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.
PubMed 10595602Almeida OD Jr. Awake microlaparoscopy with the Insuflow device. JSLS. 2002 Jul-Sep;6(3):199-201.
PubMed 12166755Demco 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.
PubMed 11342732Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
PubMed 1688289Braga 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.
PubMed 12454514Chen 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.
PubMed 9822465Franklin 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.
PubMed 8831545Franklin 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.
PubMed 7482191Schwenk 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.
PubMed 9716766Birch 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.
PubMed 21249696Ott 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.
PubMed 10036122
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03330067
- Acronym / sponsor ID
- GCO 16-2223
- Conditions
- Pneumoperitoneum
- Keywords
- laparoscope
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are not performing the study and we don't plan to continue. We do not have support to complete the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold and dry CO2 pneumoperitoneum | Sham comparator | Device: Cold and dry CO2 pneumoperitoneumPneumoperitoneum is created by insufflation of standard cold (19-21°C) and nonhumidified (0%) CO2 directly from a standard CO2 tank or wall source. |
| Warm and humidified CO2 pneumoperitoneum | Experimental | Device: Warm and humidified CO2 pneumoperitoneumThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective laparoscopic colorectal resection (LCR) for all indications (cancer, diverticular disease, benign neoplasm, inflammatory bowel disease, etc)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold and dry CO2 pneumoperitoneumIn this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2. | Device | Cold and dry CO2 pneumoperitoneum |
| Warm and humidified CO2 pneumoperitoneumAlso: Lexion Insuflow deviceIn this arm, patients undergo pneumoperitoneum by the insufflation of warmed (95° F) and humidified (95% relative humidity) CO2, using a Lexion Insuflow device. | Device | Warm and humidified CO2 pneumoperitoneum |
Primary outcome
Number of pain medications taken postoperatively
Time frame: up to 7 days
The number of pain medications administered while hospitalized postoperatively will be tracked and recorded.
Timing of pain medications taken postoperatively
Time frame: up to 7 days
The timing of pain medications administered while hospitalized postoperatively will be tracked and recorded.
12 secondary outcomes
Postoperative pain levels
Time frame: up to 21 days
Number of pain medications taken after discharge
Time frame: up to 21 days
Intraoperative narcotic use
Time frame: Day 1
Analgesia requirements in the post anesthesia care unit
Time frame: Day 1
Volume of CO2 consumed during surgery
Time frame: Day 1
Length of stay
Time frame: up to 21 days
Time to first flatus
Time frame: up to 21 days
Time to first bowel movement
Time frame: up to 21 days
Time to solid diet
Time frame: up to 21 days
Postoperative complications
Time frame: up to 21 days
Duration of Surgery
Time frame: Day 1
Incision length
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 11591939Neuhaus 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.
- Background: PubMed 20552372Brokelman 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.
- Background: PubMed 15836853Erikoglu 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.
- Background: PubMed 10595602Holmdahl 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.
- Background: PubMed 12166755Almeida OD Jr. Awake microlaparoscopy with the Insuflow device. JSLS. 2002 Jul-Sep;6(3):199-201.
- Background: PubMed 11342732Demco 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.
- Background: PubMed 1688289Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc. 1991 Sep;1(3):144-50.
- Background: PubMed 12454514Braga 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.
- Background: PubMed 9822465Chen 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.
- Background: PubMed 8831545Franklin 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.
- Background: PubMed 7482191Franklin 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.
- Background: PubMed 9716766Schwenk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Whelan, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold and dry CO2 pneumoperitoneum and Warm and humidified CO2 pneumoperitoneum in people with Pneumoperitoneum, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pain medications taken postoperatively (time frame: up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330067, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.