Operational Guidelines for Laparoscopic Radical Colorectal Cancer Surgery (2023 Edition)

Authors: Laparoscopic and Endoscopic Surgery Group of the Surgery Branch of the Chinese Medical Association, Colorectal Surgery Group of the Surgery Branch of the Chinese Medical Association, Colorectal Surgery Expert Working Group of the Surgeon Branch of the Chinese Medical Doctor Association, Laparoscopic and Robotic Surgery Branch of the Chinese Anti-Cancer Association, and Laparoscopic and Minimally Invasive Technology Branch of the Chinese Association of Medical Equipment

Source: Chinese Journal of Digestive Surgery, 2024, 23(1)

summary

Laparoscopic technique is currently an important means of radical surgical treatment of colorectal cancer. In recent years, with the further development and popularization of laparoscopic radical colorectal cancer surgery in mainland China, surgical techniques and concepts have undergone great changes and updates, and high-quality clinical studies and evidence-based medical evidence have been continuously released around the world. Laparoscopic radical colorectal cancer surgery has made many advances in surgical indications, laparoscopic display systems, surgical approaches, total laparoscopic surgery, and laparoscopic key anatomical landmarks and operation points. Based on the "Operation Guidelines for Laparoscopic Colorectal Cancer Surgery (2018 Edition)", combined with recent research hotspots and high-level evidence-based medical achievements, based on clinical evidence and guided by clinical problems, the Laparoscopic and Endoscopic Surgery Group of the Surgery Branch of the Chinese Medical Association, the Colorectal Surgery Group of the Surgery Branch of the Chinese Medical Association, the Colorectal Surgery Expert Working Group of the Surgeon Branch of the Chinese Medical Doctor Association, the Laparoscopic and Robotic Surgery Branch of the Chinese Anti-Cancer Association, The Laparoscopic and Minimally Invasive Technology Branch of the China Association of Medical Equipment organized domestic experts in related fields to revise and update the "Operational Guidelines for Laparoscopic Radical Colorectal Cancer Surgery (2023 Edition)".

Laparoscopic technique was first applied to the field of colorectal surgery, and has become an important means of radical surgical treatment of colorectal cancer. In order to popularize and standardize the clinical practice of laparoscopic colorectal cancer surgery in mainland China, the first edition of the "Operation Guidelines for Laparoscopic Colorectal Cancer Surgery" was first published in 2006 and updated and revised in 2018, and it has been 17 years since then. In recent years, with the further development and popularization of laparoscopic radical colorectal cancer surgery in mainland China, surgical techniques and concepts have undergone great changes and updates on the basis of the "Laparoscopic Colorectal Cancer Surgery Operation Guidelines (2018 Edition)", and high-quality clinical studies and evidence-based medical evidence have been continuously released around the world. Based on this, in order to meet the needs of discipline development and clinical practice, the Laparoscopic and Endoscopic Surgery Group of the Surgical Branch of the Chinese Medical Association, the Colorectal Surgery Group of the Surgical Branch of the Chinese Medical Association, the Colorectal Surgery Expert Working Group of the Surgeon Branch of the Chinese Medical Doctor Association, the Laparoscopic and Robotic Surgery Branch of the Chinese Anti-Cancer Association, and the Laparoscopic and Minimally Invasive Technology Branch of the Chinese Association of Medical Equipment organized domestic experts to update and revise the "Laparoscopic Colorectal Cancer Surgery" in the key areas of laparoscopic colorectal cancer surgery, based on evidence-based medical evidence, and focusing on key clinical issues. Laparoscopic Colorectal Cancer Surgery Operation Guidelines (2018 Edition)" to form the "Laparoscopic Colorectal Cancer Radical Colorectal Cancer Operation Guidelines (2023 Edition)".

1. Level of evidence and level of recommendation

The evidence included in this guideline is graded according to the Oxford centre for evidence-based medicine (OCEBM) grading system, with recommended levels A, B, C, and D.

(1) Level of evidence

The level of evidence was as follows: 1A: systematic review of RCTs (homogeneous studies) and 1B: high-quality RCTs. Grade 2A: systematic review of studies at level 2B (homogeneous across studies), grade 2B: prospective controlled studies (or RCTs of slightly lower quality), and category 2C: outcome studies (large sample analysis, population data, etc.). Level 3: Retrospective controlled study, case-control study. Level 4: Case studies (i.e., studies without a control group). Level 5: Expert opinion, animal or laboratory research.

(2) Recommended level

The level of recommendation from highest to lowest is: A: strongly recommended based on level 1 evidence ("standard" and "must be performed"). Grade B: Based on level 2 or 3 evidence, or inferences based on level 1 evidence, recommended ("recommended", "should be performed"). Level C: Based on Level 4 evidence, or inferences based on Level 2 or 3 evidence, recommended ("Select", "Can Execute"). Grade D: based on level 5 evidence, or based on evidence of lack of consistency or level of uncertainty, no recommendation, only a narrative.

2. Indications and contraindications for surgery

(1) Indications for surgery

1. Initially resectable colorectal cancer. For colorectal cancer that is evaluated as non-metastatic and locally resectable before surgery, there has been more high-level evidence-based medical evidence to confirm the safety and efficacy of laparoscopic colorectal surgery, and has been evaluated in the Chinese Society of Clinical Oncology (CSCO) guidelines, the National Comprehensive Cancer Network (NCCN) guidelines, It is recommended in the Japanese Colorectal Cancer Treatment Regulations.

For non-metastatic colon cancer with cT4b, combined organ resection or local resection of the invaded site can be selected depending on the site and extent of tumor invasion. Due to the requirement of R0 resection, there is still controversy about the safety and efficacy of laparoscopic surgery in patients with cT4b colon cancer, and most of the relevant evidence-based medical evidence is retrospective. Some studies have shown that the laparoscopic group can achieve similar outcomes to the open surgery group. Zhang et al. compared patients with laparoscopic multi-organ resection with patients undergoing laparotomy for cT4b colon cancer and patients undergoing laparotomy, and found that there was no significant difference in R0 resection rate between the laparoscopic group and the laparotomy group. The retrospective results of Miyo et al. showed that the laparoscopic group could achieve similar oncological efficacy to the laparotomy group while reducing trauma. However, some studies have shown that laparoscopy has certain limitations. The results of the retrospective controlled study by Duraes et al. showed that the oncological efficacy of the laparoscopic group was similar to that of the laparotomy group, but the laparoscopic group had a higher rate of conversion to laparotomy, so the laparotomy group had the advantage of being more convenient. Eom et al. found that laparoscopic surgery was one of the risk factors for poor disease-free survival (DFS) for cT4b colon cancer.

Recommendation 1: Laparoscopy can be used for non-metastatic initial resectable colorectal cancer. (Level of evidence: 1A; level of recommendation: A)

2. Colorectal cancer after neoadjuvant/conversion therapy. For rectal cancer after neoadjuvant therapy, laparoscopic radical surgery has similar efficacy and prognosis compared with traditional laparotomy. A Korean multicenter RCT (COREAN study) compared 340 patients with low- and medium-level rectal cancer who received neoadjuvant chemoradiotherapy, and the short-term postoperative results showed that the laparoscopic group had less bleeding than the laparotomy group, the operation time was longer, the postoperative bowel function recovery was faster, the postoperative analgesic was used less, and the postoperative physiological function and nutritional status were better. The 10-year follow-up results published in 2021 showed that there was no significant difference in the overall survival, disease-free survival and local recurrence-free survival between the two groups.

For colon cancer, the current standard of care is curative surgical resection combined with postoperative adjuvant chemotherapy. The CSCO guidelines point out that for some patients with T4bM0 stage, even combined organ resection cannot achieve the goal of radical cure, but for potentially resectable patients, conversion therapy can be selected first. At present, there is a lack of head-to-head controlled studies on laparoscopic and open surgery for colon cancer after conversion therapy, but some of the relevant studies have performed laparoscopically and have not shown significant laparoscopy-related adverse outcomes and obvious oncological efficacy disadvantages, so laparoscopy can be used as a surgical option for colon cancer after conversion therapy if R0 resection can be achieved through preoperative or intraoperative evaluation.

Recommendation 2: Laparoscopy can be used for radical surgery for colorectal cancer after neoadjuvant/conversion therapy. (Level of evidence: 1B; level of recommendation: A)

3. Metastatic colorectal cancer. For locally resectable stage IV colorectal cancer, laparoscopy of primary bowel segment resection can be based on the principle of non-metastatic colorectal cancer. The results of relevant studies have shown that laparoscopy can achieve better safety and efficacy in staged resection or simultaneous resection of primary lesions, metastases, and laparoscopic surgery has certain advantages over traditional laparotomy in terms of short-term efficacy and postoperative rehabilitation. The results of the meta-analysis by Morarasu et al. showed that compared with the laparotomy group, the laparoscopic group had faster postoperative recovery, fewer postoperative complications, and lower postoperative recurrence rate compared with the laparotomy group. Therefore, laparoscopy as a local radical surgery for stage IV colorectal cancer has a good safety and oncological efficacy. For the resection of metastases, the timing and method of surgery must be determined according to the location, size, number and general condition of the metastases, etc., and are not explained in detail in this guideline.

Recommendation 3: Laparoscopy can be applied to intestinal segment resection + regional lymph node dissection for metastatic colorectal cancer. (Level of evidence: 3; level of recommendation: B)

(2) Contraindications to surgery

1. Relative contraindications. (1) Colorectal cancer combined with intestinal obstruction. (2) cT4b colorectal cancer has a large invasion range.

2. Absolute contraindications. (1) The general condition before surgery is not good, and there is severe insufficiency of heart, lung, liver and kidney and cannot tolerate general anesthesia surgery. (2) Inability to tolerate CO2 pneumoperitoneum. (3) Pregnancy.

3. Equipment and instruments

(1) Display equipment

Including conventional high-definition camera and display system, 3D laparoscopic imaging system, 4K ultra-high-definition laparoscopic imaging system, near-infrared fluorescence laparoscopic imaging system, or an imaging system that integrates the above systems.

3D laparoscopy can provide the surgeon with stereo vision imaging, which has certain advantages in intraoperative anatomical identification and some surgical operations. In terms of rectal surgery, the RCT results of 3D laparoscopy versus traditional laparoscopic rectal surgery in mainland China showed that there were no significant differences in operation time, intraoperative blood loss, number of lymph node dissection, and postoperative hospital stay, while in colon surgery, relevant research results showed that 3D laparoscopy had certain advantages in intraoperative blood loss, number of D3 lymph node dissection, laparoscopic anastomosis time, etc. Compared with conventional high-definition laparoscopy, 4K ultra-high-definition laparoscopy has more advantages in the identification of anatomical structures, especially the observation of microscopic structures. In recent years, with the increasing attention to the technical points such as finding the correct tissue gap, protecting the pelvic autonomic nerve, and preserving the integrity of the mesangium, the above advantages of 4K ultra-high-definition laparoscopy have potential advantages in improving the quality of surgery and reducing surgical complications.

In recent years, near-infrared fluorescence imaging systems based on indocyanine green have also been applied in laparoscopic colorectal surgery: indocyanine green can be used to evaluate the blood supply to the anastomosis, and the re-completion of gastrointestinal reconstruction in patients with poor blood supply can reduce the occurrence of anastomotic leakage; Studies have also shown that indocyanine green can help improve the resection of suspicious peritoneal metastatic nodules and liver metastatic micronodules.

Recommendation 4: 3D laparoscopic imaging system and 4K ultra-high-definition laparoscopic imaging system can be used as display equipment for conventional laparoscopic surgery. (Level of evidence: 2B; level of recommendation: B)

Recommendation 5: The near-infrared fluorescence laparoscopic system can be used to evaluate the blood supply of the anastomosis, the localization of lesions, and the development of lymph nodes during surgery. (Level of evidence: 3; level of recommendation: B)

(2) Operate equipment

Conventional operating instruments: including laparoscopic lens, pneumoperitoneum needle, trocar puncture needle (Trocar), separation forceps, non-injury grasping forceps, scissors, needle holders, vascular clips, clamps, incision protectors, etc.

Energy devices and energy platforms: monopolar electric energy devices, bipolar electric energy devices, ultrasound energy devices, integrated devices and other energy platforms and instruments are suitable for conventional colorectal surgery, and the corresponding instruments can be selected according to the specific intraoperative situation and the operator's habits.

Suture instruments and sutures: In some colorectal surgeries, due to surgical needs [such as anastomosis suture reinforcement, complete laparoscopic intracavity anastomosis, transanal total mesorectal excision (taTME) purse suture, etc.], laparoscopic needle holders and sutures, complete laparoscopic anastomosis reinforcement sutures, common orifice closure, etc., barbed threads are recommended.

Anstomosis instruments: According to the anastomosis needs of different parts, you can choose a straight cutting closure or a circular stapler, and the appropriate nail length and nail height must be selected according to the specific anastomosis site and anastomosis method, and manual or electric stapler instruments can be used as a conventional surgical option.

(3) Other equipment

It includes laparoscopic pneumoperitoneum equipment, irrigation suction system, image recording and storage system, etc.

Fourth, the type of surgery

(1) Surgical method

1. Total laparoscopic colorectal cancer surgery. Intestinal segment resection, mesangial cutting, lymph node dissection, and gastrointestinal reconstruction were all performed laparoscopically. With the advancement of laparoscopic techniques and anastomosis devices, endoluminal anastomosis can reduce the free range of the intestinal tube and mesangium, reduce the risk of impairing the blood supply and function of the intestinal tube, reduce the traction of the mesangium, and reduce the dependence on the length of the incision. Therefore, the use of total laparoscopic surgery is gradually increasing.

2. Laparoscopic assisted colorectal cancer surgery. Intestinal segment free and lymph node dissection is done laparoscopically, and intestinal segment resection and/or gastrointestinal reconstruction is done through assisted small incisions. This type of surgery is currently the most widely used.

3. Hand assisted laparoscopic colorectal cancer surgery. During laparoscopic surgery, the surgeon inserts his hand into the patient's abdominal cavity through a small incision in the abdominal wall to assist in the operation. This type of surgery is rarely used today.

(2) Types of surgery

(1) Laparoscopic ileocececal resection. (2) Laparoscopic right hemicolectomy. (3) Laparoscopic transverse colectomy. (4) Laparoscopic left hemicolectomy. (5) Laparoscopic sigmoidectomy. (6) Laparoscopic anterior rectal resection. (7) Laparoscopic abdominoperineal resection. (8) Laparoscopic total colectomy. (9) Laparoscopic subtotal colectomy, etc.

5. Basic principles of surgery

(1) The scope of surgical resection

The surgical resection scope of laparoscopic radical colorectal cancer should be the same as that of open surgery, with the resection margin of colon cancer ≥ 10 cm from the tumor, the distal margin of medium and high rectal cancer ≥5 cm from the tumor, the distal margin of low rectal cancer ≥ 2 cm from the tumor, and the distal margin of T1~2 rectal cancer or T2~4N0~1 stage of rectal cancer undergoing neoadjuvant therapy can also be 1 cm from the tumor (level of evidence: 2B).

In laparoscopic colorectal surgery, the precise surgical level should be followed, and the embryological theory should be used as the anatomical basis, and the avascular space between the visceral layer and the parietal fascia should be sharply separated, and the integrity of the mesangium should be maintained, and the primary tumor lesion, mesentery and regional lymph nodes should be resected together. The principles include: (1) sharp separation between the parietal fascia and the visceral fascia to avoid any damage to the visceral fascia that may lead to tumor spread. (2) The initial part of the colorectal vessel must be completely exposed and ligated at the root to achieve maximum lymph node dissection. The short-term follow-up data of one multicenter RCT (RELARC study) in China showed that although the incidence of intraoperative vascular injury was slightly higher than that in the D2 lymph node dissection group (3% vs. 1%), right hemicolectomy following the principle of complete mesocolic excision (CME) could reduce III.~Grade IV. postoperative complication rates and no statistically significant difference in overall postoperative complication rates compared with D2 lymph node dissection confirms the safety and feasibility of CME (level of evidence: 1B). In terms of long-term efficacy, the results of a retrospective study in Denmark showed that CME in stage I~III colon cancer had better DFS than traditional surgery (level of evidence: level 3).

Recommendation 6: The scope of surgical resection for laparoscopic radical colorectal cancer surgery should be the same as that for laparotomy, and the TME principle is recommended for radical rectal cancer resection, and CME principle is recommended for radical colon cancer resection, and sufficient intestinal resection margin should be ensured, and the resection of the primary tumor, mesentery and regional lymph nodes should be completed (recommended grade: grade A).

(2) Lymph node dissection

For patients with no lymph node metastasis found in preoperative evaluation or intraoperative exploration, the scope of lymph node dissection is determined according to the depth of tumor invasion into the intestinal wall: (1) For cTis stage colorectal cancer (confined to the mucosa), D0 (local resection) or D1 (intestinal segment resection) lymph node dissection can be selected. (2) For patients with cT1 colorectal cancer infiltrated to the submucosa, D2 lymph node dissection is required because the probability of lymph node metastasis is close to 10%, and it is often accompanied by intermediate (second station) lymph node metastasis. (3) For cT2 colorectal cancer (infiltrated to the muscularis propria), at least D2 lymph node dissection is required, and D3 lymph node dissection can also be selected. (4) For colorectal cancer with cT3, cT4a, cT4b or any T stage but suspicious regional lymph node metastasis found in preoperative examination, or suspicious lymph node metastasis found in intraoperative exploration, D3 lymph node dissection shall be performed.

Recommendation 7: The principle of lymph node dissection for laparoscopic radical colorectal cancer surgery should be the same as that of laparotomy, and the corresponding range of lymph node dissection should be performed based on the lymph node metastasis of preoperative evaluation or intraoperative exploration or the depth of tumor infiltration into the intestinal wall (recommended grade: grade A).

(3) Surgical approach

1. Laparoscopic radical resection approach for rectal cancer and sigmoid colon cancer. (1) Intermediate approach. The sigmoid mesocolon was opened at the horizontal Toldt′s line projection of the sacral promontory, the Toldt′s space was expanded, the submesenteric vascular root or its branches were dissected, and the sigmoid mesocolon was free from the middle to the outside (level of evidence: level 1).

(2) Lateral approach. It enters the Toldt′s space from the left paracolic groove or the attachment of the abdominal wall of the sigmoid colon, and the mesocolon is free from the outside to the inside, and then the submesenteric vascular root or its branches are processed.

(3) Median cephalad approach. The inferior mesenteric vein, which is anatomically fixed and distinct, is used as a landmark. The mesocolon opens horizontally from the flex ligament and expands the left posterior colonic space near the cephalad. This approach can be applied to most laparoscopic radical rectal cancer surgery, especially for those with obesity or mesangial hypertrophy that makes anatomical landmarks such as the traditional intermediate approach submesenteric vessels difficult to identify. The results of previous studies showed that there were no significant differences between the cephalad intermediate approach and the traditional lateral intermediate approach in terms of operation time, intraoperative blood loss, number of lymph node dissections, and distance of tumor inferior resection margins (level of evidence: 3). The results of a single-blind multicenter prospective RCT in China showed that the cephalic intermediate approach group could achieve better 3-year overall survival (OS) than the traditional lateral intermediate approach group, and at the same time obtained more No.253 lymph node dissections, which showed the good safety and feasibility of the cephalad intermediate approach (level of evidence: 2B).

(4) Transanal approach. taTME is divided into complete taTME and laparoscopic-assisted taTME. taTME is usually performed by transanal endoscopic microsurgery (TEM) or transanal minimally invasive surgical platforms. taTME is mainly suitable for low rectal cancer, especially for male, prostatic hypertrophy, obesity, tumor length diameter of > 4 cm, mesorectal hypertrophy, anterior rectal wall tumor, pelvic stenosis, and unclear tissue plane caused by neoadjuvant radiotherapy. Its key technologies include: suture closure technology of intestinal lumen distal to the tumor, access to the correct layer gap, bottom-up mesorectal separation technology, anastomosis safety judgment and reinforcement suture technology.

In recent years, a lot of evidence-based medical evidence on taTME has been published, mainly focusing on key issues such as postoperative local recurrence and long-term survival. Larsen et al.'s study included 110 rectal cancer patients treated with taTME from 2015 to 2017, and 10 patients had local recurrence during the follow-up period, which was much higher than that of patients who underwent TME surgery during the same period (local recurrence rate was 9.5% vs. 3.4%), and the recurrence time was shorter than 1 year after surgery. The other study of 159 patients in the Netherlands did not observe similar conclusions. The results of the study showed that the 3-year and 5-year local recurrence rates were 2.0% and 4.0%, respectively, the median local recurrence time was 19.2 months, and the 3-year and 5-year DFS were 92% and 81%, respectively. As of 2023, the largest multicenter study of taTME enrolled a total of 767 patients, with a 2-year local recurrence rate of only 3%, and no multifocal local recurrence was observed. The results of a cohort study of 120 patients showed that the overall local recurrence rate was 10%, the mean recurrence interval was 15.2 months, and the multifocal local recurrence rate was 6.66%. In a subsequent long-term cohort study of 266 patients, the local recurrence rate was 5.6%, but decreased to 4.0% after excluding the first 10 surgeries at each medical center. These evidences confirm the oncological safety of taTME and suggest that the local recurrence rate may be related to the quality of the procedure rather than the procedure itself.

★

Click on the link below to view the full article

★

Operational Guidelines for Laparoscopic Radical Colorectal Cancer Surgery (2023 Edition)