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Hypothermia

Body Temperature Changes

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Benzocaine

Tannic Acid

HumiGard device will be used to provide warmed humidified CO2 for insufflation during laparoscopic surgery. The device will be used alongside standard methods of keeping the patient warm in theatre. The theatre team will monitor the patient's temperature at regular time points before, during and after surgery. Warmed fluids, forced air warming devices or warmed blankets will be used as required to maintain normothermia.

Patients will receive standard methods of keeping the patient warm in theatre. The theatre team will monitor the patient's temperature at regular time points before, during and after surgery. Warmed fluids, forced air warming devices or warmed blankets will be used as required to maintain normothermia.

A sham HumiGard device will be used in the standard care arm. This will be the same HumiGard device as is in the intervention arm. However, the sham device will be turned "off" so that the gas delivered to the peritoneal cavity for insufflation is not heated or humidified. The sham device will deliver CO2 (as is the case for current standard practice in the hospital) through the HumiGard tubing. The sham device will look and sound the same as the active intervention arm where the HumiGard device is switched "on" and is delivering warm, humidified CO2 to the peritoneal cavity.

HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery

HumiGard device

Standard methods of keeping the patient warm whilst in theatre, including warmed IV fluids, warming blankets/forced air warming devices.

Standard care (with sham HumiGard device)

Nicola Reeves, MD

During long surgical procedures under general anaesthetic, patients' body temperatures sometimes drop below 36°C. This is classified as hypothermia. These low temperatures are associated with medical complications and surgical wound infections. Despite various warming methods used during surgery a significant number of patients experience hypothermia during surgery. During laparoscopic procedures, standard practice is to use dry, unwarmed carbon dioxide (CO2) to inflate the peritoneum (insufflation). This may contribute to the risk of hypothermia and cause tissue desiccation.

HumiGard is a CE marked device which humidifies and heats CO2 for insufflation. It is used together with other standard methods of keeping patients warm. Other studies suggest that the HumiGard device may prevent hypothermia, and help patients recover more quickly and with fewer problems after surgery.

The investigators aim to find out whether the HumiGard device used with standard practice, gives better outcomes for patients, compared to standard care alone. To do this, the investigators first need to work out if such a study would be feasible to do and therefore whether a larger study can be done.

A total of 40 patients who are having a laparoscopic colectomy operation (where a portion of their bowel is removed) will be recruited. Half will be treated with the HumiGard device plus standard care and half will be treated with a sham HumiGard device plus standard care. Patients will be allocated to one of these groups by random chance. Neither the patient, the surgeon, nor the assessor will know which treatment the patient is having.

The investigators will measure patients' temperature during surgery, and also patients will be asked to complete a validated questionnaire to measure their quality of recovery and pain following surgery. The feasibility study will aim to highlight the most appropriate outcomes to be measured in a larger RCT.

Laparoscopic surgery involves filling the peritoneal cavity with carbon dioxide (CO2) gas (insufflation) to increase the working and viewing space in the abdomen. It is standard care in the United Kingdom (UK) to use dry, unwarmed CO2. There is evidence that dry, unwarmed insufflation is associated with tissue desiccation and intraoperative hypothermia showing that insufflation of cool dry gas resulted in a temperature drop of 1.3-1.7°C. Despite active warming methods, perioperative hypothermia is common. One study demonstrated that nearly half of patients had continuous core temperatures of 36°C for more than an hour.

HumiGard (Fisher and Paykel Healthcare) is a CE marked medical device designed to humidify and heat CO2 for insufflation. A meta-analysis included 13 studies (total of 796 patients) comparing warmed, humidified CO2 insufflation compared to unwarmed, dry CO2 in patients having a range of procedures. There was a significant difference in mean core temperature change, and an effect size of +0.3°C (95% confidence interval \[CI\]: 0.1-0.6). This was more pronounced in studies of long procedures (80 min). Another meta-analysis of 15 studies (1026 patients) demonstrated a small beneficial effect on immediate post-operative pain but not at day 1 or 2. Warmed, humidified CO2 reduced the risk of intraoperative hypothermia (p=0.004) but postoperative core temperatures were not significantly different (10 studies, 718 patients). No differences were observed in analgesic consumption, length of stay, or procedure duration.

This is a blinded, randomised controlled feasibility study on 40 patients receiving laparoscopic colorectal resectional surgery at a single site (University Hospital of Wales) and treated with either the HumiGard device plus standard care (20 patients) or a sham HumiGard device plus standard care (20 patients).

This study will assess various aspects of a proposed larger pragmatic blinded, RCT evaluating whether HumiGard insufflation device, when used with standard care, can improve patients' quality of recovery after laparoscopic colectomy surgery.

The feasibility study will aim to highlight the most appropriate outcomes to be measured in a main RCT, particularly looking at the role of Quality of Recovery (QoR-40) questionnaire or continuous temperature measurements. The investigators will assess whether the outcomes of the study are suitable, achievable and measurable. The study will assess recruitment, ability to blind operating surgeon with a sham HumiGard device, use of urinary temperature probe compared to standard temperature monitoring in theatre, use of QoR-40 and visual analogue score (VAS) pain score by patients preoperatively (for a baseline score) and on post-operative day (POD) 1, 3 and 30, analgesia use, and intraoperative patient warming techniques. Length of stay in hospital from procedure to discharge (or until medically fit for discharge) will also be recorded and reported.

Furthermore, methods for analysing the postoperative complication rate will be evaluated. Complications will be recorded at POD1, POD3, upon discharge and POD30. Their severity will be graded using the Clavien-Dindo scale, a widely used and valid method for grading severity of surgical complications which helps to reduce subjectivity. The Comprehensive Complication Index (CCI) will then be used to create a composite score (0-100) for each patient.

Feasibility study - 40 patients to be randomised 1:1 to two groups - 50% receiving HumiGard and 50% receiving standard care alone

Everyone will be blinded except for one member of the theatre staff who will operate the HumiGard, and the research team member who performs the randomisation process.

HEAT HumiGard Evaluation Study

Quality of Recovery and Perioperative Hypothermia in Elective Colectomy Patients: A Feasibility Study of a Blinded Randomised Controlled Trial

The recruitment rate will be assessed using the "screening and recruitment log" which will record the number of patients recruited each month and reasons for non-recruitment will be described.

The number of patients who successfully complete the QoR-40 questionnaire and VAS score pre-operatively and at post-operative days 1,3,30 will be measured.

The number of patients who have successful continuous intra-operative temperature readings using a urinary temperature probe will be measured. The feasibility of using these data to identify periods of intraoperative hypothermia will also be assessed.

The number of cases in which the treating surgeon correctly predicted the study arm allocation of the patient (HumiGard vs sham device) will be recorded in the case report form.

Cardiff and Vale University Health Board

Trial Manager

Herbal and Botanical

Cola

Woo Yong Lee, MD,PhD

This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).

Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy

Samsung Medical Center

Woo Yong Lee/Associate Professor, Department of Surgery, Samsung Medical Center

Wounds and Injuries

Surgical Wound

patients with colorectal cancer and undergo single incision laparoscopic surgery

patients with colorectal cancer and undergo conventional laparoscopic surgery

Patients undergo single incision laparoscopic surgery

single incision laparoscopic surgery

Patients undergo conventional laparoscopic surgery

conventional laparoscopic surgery

Liu Kun, MD

Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Single Incision Laparoscopic Colorectal Surgery

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease

Estimated blood loss（milliliters，ml）

Length of proximal and distal margin （centimeters，cm）

The diameter of tumors（centimeters，cm）

Duration of hospital stay（days after surgery）

Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）

Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge

Ruijin Hospital

chief physicion

Neoplasms

Carcinoma

Postoperative Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients offered surgery with the retractor sponge

Patients receiving standard care: surgery in Trendelenburg position

Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.

Sponge

Anke B Smits, MD

Alice M Couwenberg, BSc

Anke B Smits, MD/PhD

Johannes PM Burbach, MD

Helena M Verkooijen, MD/AssProf

Peter G Noordzij, MD/PhD

Onne Reerink, MD/PhD

Marco van Vulpen, MD/Prof

Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.

Objective: We study the efficacy of the retractor sponge in laparoscopic colorectal surgery to reduce hospital stay in patients operated for a malignancy. Secondary objectives are duration of surgery, blood-loss, use of diuretics as volume therapy (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative complications.

Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.

Study population: Patients with colorectal cancer who undergo laparoscopic surgery, and who have given informed consent to be offered experimental interventions within the PICNIC project. Patient who require open surgery or patients with benign colorectal diseases are excluded for this study.

Intervention: Intraoperative use of the retractor sponge versus usual care, i.e. the Trendelenburg position.

Main study parameters/endpoints: The primary endpoint is length of hospital stay. Secondary endpoints are duration of surgery, blood-loss, use of diuretics (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative surgical, pulmonary and cardiac complications.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will be conducted according to the cohort multiple Randomized Controlled Trial (cmRCT) design. Within the PICNIC cohort, we will identify all patients who are eligible for the experimental intervention (use of the sponge) and who have given informed consent to be invited for future experimental interventions. From this sub cohort, we will randomly select a group of patients to whom we will offer surgery with use of the retractor sponge, which they can accept or decline. Eligible patients from the sub cohort who were not randomly selected will undergo standard treatment, i.e. surgery in Trendelenburg position. We do not expect adverse events in patients in the intervention arm, besides dysfunction of the sponge, after which conversion to standard treatment (Trendelenburg position) needs to take place.

Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery

Randomized Controlled Trial to Evaluate the Effect of a Retractor Sponge in Postoperative Hospital Stay in Laparoscopic Colorectal Surgery in Patients With Malignancy

St. Antonius Hospital

Dr. A.M. Smits

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Rocuronium

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Deep neuromuscular block using rocuronium and reversal with suggamadex

Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion

Moderate neuromuscular block using rocuronium and reversal with suggamadex

Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an increased mean arterial pressure and systemic vascular resistance due to sympathetic excitation in the cardiovascular system. 10\~15 mmHg intra-abdominal pressure is required in order to achieve a pneumoperitoneum, and increased abdominal pressure following a pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by increasing the left ventricular end systolic wall stress and the right and left ventricular filling pressure, while decreasing the stroke volume and cardiac index. The author compared the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for colorectal cancer as part of preliminary research. The results showed that deep muscle relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle relaxation, the surgeon was able to maintain a view almost identical to the one afforded by medium muscle relaxation. However, up until now, no reports have clearly indicated the change in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and surgical prognosis depending on the depth of muscle relaxation.Against this background, this study aims to identify the degree to which intra-abdominal pressure in laparoscopic colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages this method presents in terms of physiological changes such as hemodynamic and respiratory system changes. In addition, the study intends to examine the difference between deep muscle relaxation and medium muscle relaxation in terms of surgical prognosis, including their effects on post-operative pain and on the patient's recovery of intestinal mobility.

The Benefits of Deep Neuromuscular Block and Sugammadex in Laparoscopic Colorectal Surgery

The difference of intra-abdominal pressure during peumoperitoneum between deep neuromuscular block and moderate neuromuscular block to identify the degree to which deep muscle relaxation can reduce intra-abdominal pressure while maintaining the surgeon's view in a laparoscopic colorectal surgery or laparoscopic rectal surgery, as well as examine the simultaneous hemodynamic changes and changes in the respiratory system.

Yonsei University

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

Patients underwent curative surgery with dissection of No.253 Lymph node

Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor.

Laparoscopic colorectal surgery

Qian Liu, Dr.

Mingguang Zhang, Dr.

Yi Xiao, Dr.

Lei Zhou, Dr.

Aiwen Wu, Dr.

Xiaohui Du, Dr.

The goal of this observational study is to learn about the the pattern of metastasis of the No.253 lymph node in colorectal cancer. The main questions it aims to answer are: 1. What are the risk factors for metastasis to the No.253 lymph node? 2.What is the prognosis for patients with metastasis to the No.253 lymph node? Patients with descending colon cancer, sigmoid colon cancer, and rectal cancer who undergo curative surgery with dissection of the No.253 lymph node are included in this study

The No. 253 lymph node (also named as apical lymph node of inferior mesenteric artery), as the third station in the inferior mesenteric artery lymphatic system, plays a vital role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They serve as the last barrier for tumor metastasis from regional to distant sites. The definition of the range of the No.253 lymph node primarily follows the Japanese Colorectal Cancer Treatment Guidelines: the medial boundary is the segment from the root of the inferior mesenteric artery to the origin of the left colic artery, the caudal boundary is from the origin of the left colic artery to the intersection with the inferior mesenteric vein, the lateral boundary is the outer margin of the inferior mesenteric vein, and the cranial boundary is from the horizontal section of the duodenum to the beginning of the jejunum. However, the pattern of metastasis of the No.253 lymph node in colorectal cancer remains unclear, with most studies being retrospective and showing significant differences in results. Therefore, the investigator plans to be the first internationally to carry out this retrospective, registry-based study to determine the metastasis pattern to the No. 253 lymph node in colorectal cancer. This will provide definitive clinical evidence for D3 lymph node dissection in colorectal surgery.

Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer

Real World Registry Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer

Pathologically confirmed tumor cell infiltration in the No.253 lymph node

Total number of lymph nodes dissected in the pathology report

The proportion of short-term complications occurring within 30 days post-surgery

Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.

Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.

Overall survival refers to the length of time from the primary treatment that patients are still alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HEAT HumiGard Evaluation Study	NCT04164706	Laparoscopic Co...	HumiGard device Standard care (...	18 Years -	Cardiff and Vale University Health Board
Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy	NCT00744159	Immunity		20 Years - 80 Years	Samsung Medical Center
Single Incision Laparoscopic Colorectal Surgery	NCT03151733	Laparoscopic Co...	single incision... conventional la...	18 Years - 80 Years	Ruijin Hospital
Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery	NCT03334383	Colon Carcinoma Rectum Carcinom...	Sponge	18 Years - 95 Years	St. Antonius Hospital
The Benefits of Deep Neuromuscular Block and Sugammadex in Laparoscopic Colorectal Surgery	NCT02266056	Colorectal Canc...	Deep neuromuscu... Moderate neurom...	19 Years - 70 Years	Yonsei University
HEAT HumiGard Evaluation Study	NCT04164706	Laparoscopic Co...	HumiGard device Standard care (...	18 Years -	Cardiff and Vale University Health Board
Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer	NCT06135571	Colorectal Canc... Lymph Node Meta...	Laparoscopic co...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Single Incision Laparoscopic Colorectal Surgery	NCT03151733	Laparoscopic Co...	single incision... conventional la...	18 Years - 80 Years	Ruijin Hospital

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