Digestive System Diseases

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Colitis

Colitis, Ulcerative

Ulcer

Diverticulum

Diverticular Diseases

Diverticulosis, Colonic

Diverticulum, Colon

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

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Pathological Conditions, Anatomical

Central Nervous System Depressants

All Drugs and Chemicals

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Anesthetics

Bupivacaine

Anesthetics, Local

Cola

Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

Ultrasound guided Transversus Abdominis Plane (TAP) bock

Local anaesthetic infiltration of laparoscopic port sites

Nicholas Crabtree, MB,ChB, FRCA

Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery.

Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, earlier return of bowel function and earlier hospital discharge.

The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)

Summary of Study Design The study will be a double blind randomised controlled trial with patients undergoing laparoscopic right hemicolectomy or laparoscopic high anterior resection randomly allocated into two groups, with the study group receiving bilateral TAP blocks followed by a morphine PCA and the control group receiving local anaesthetic infiltration of the laparoscopic port sites and specimen extraction site and a morphine PCA.

A double blind design was chosen to eliminate patient and observer bias in reporting of pain scores.

The presence of the control arm will ensure that any difference observed will be due to the effect of sensory nerve block due to the TAP block than due to the systemic effect of the injected local anaesthetic.

The null hypothesis will be that there is no difference between the groups in the amount of morphine consumed by the patients during 48 hours after the operation. We chose this measurement as an objective but indirect measurement of efficacy of TAP block and pain relief thus received. Measurement of pain with various scoring methods are reliable only when concurrent reduction in consumption of pain killers are demonstrated.

Recruitment and randomisation:

All patients meeting the inclusion criteria will receive a patient information leaflet and an invitation letter to participate in the study during the pre-assessment visit. We aim to recruit 72 patients (36 patients per group).

Informed consent will be taken by one of the investigators on the morning of the surgery, if the exclusion criteria are not applicable. Patients will be allotted consecutive participant numbers starting from one. Patients will be randomly allocated into either the study group and a control group. Randomisation will occur by using computer generated random numbers. Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the controlled drugs cupboard in theatre-6 anaesthetic room of Churchill hospital.Once patient has consented, the anaesthetist will open the corresponding numbered envelope and perform bilateral TAP blocks after induction of general anaesthesia, if the patient is in the study group the surgeons will infiltrate the port sites with local anaesthetic at the end of the procedure if the patient is in the control group.

Blinding:

The study group will receive bilateral TAP blocks with 20mls 0.25% bupivacaine on each side and the skin punctures on either sides will be covered with a small plaster. Patients in the control group will receive subcutaneous infiltration of the laparoscopic port sites and specimen extraction site with equivalent amount bupivacaine at the end of the procedure and small plasters will be stuck on either flanks approximately where the skin punctures for TAP block will be made.

The assessor of pain scores and morphine doses (Recovery nurse \& Colo-rectal house officer) and the patient will be blinded to group allocation.

Patient: Plasters will be stuck on flanks of all the patients both study and control group so that patient will not know if they have received TAP block.

Recovery nurse: During handover to recovery the anaesthetist and scrub nurse will not mention about group allocation.

Colo-rectal house officer: The house officers( Junior Doctors) who will be following up in the ward will not present in the operating theatre, so they will be blinded

The study duration will be from induction of anaesthesia until the patients are medically fit for discharge from hospital. No extra visits other than routinely required for the surgical procedure is expected.

Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection

Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection- a Double Blind Randomised Controlled Trial

Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.

Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain

The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered

Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.

Time will be calculated from the nursing notes and patient diary, when the patient had first successful intake of oral fluids.

Time will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.

Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.

Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.

Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.

Oxford University Hospitals NHS Trust

Consultant Anaesthetist

Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

Ultrasound guided Transversus Abdominis Plane (TAP) bock: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster

TAP Block

Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Local anaesthetic infiltration of laparoscopic port sites: Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.

Local Anaesthetic Infiltration

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United Kingdom

Region of Enrollment

8 cases converted to open and therefore excluded from analysis. 7 cases had incomplete and missing follow up data from the ward and were excluded from analysis.

Smaller number of subjects analysed than planned. Presented data should be carefully interpreted (and no conclusions should be drawn) since not enough patients were analyzed.

Dr Nicholas Crabtree

Morphine Consumption in the First 48hours After the Operation

Numerical Rating Pain Scores at 48 Hours Postoperatively

Nausea Score at 48 Hours Postoperatively

Time to First Request for Rescue Analgesia

Time to Mobilisation

Time to Successful Intake of Fluids

Time to Resumption of Normal Diet

Time to First Bowel Motion

Time to First Flatus

Time to Medically Fit to Discharge

Total Morphine Consumption at 24hours

Nausea at 24hours Post Operatively

Time to Mobilization

Time to Hospital Discharge

Overall Study

Rectal Neoplasms

Anastomotic Leak

Rectal Diseases

Postoperative Complications

After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results. In this group, a silicone tube (28Fr, Sumitomo Bakelite Co, Japan) was inserted through the anus and the tip of the tube was placed approximately 5 cm above the anastomosis at the end of the surgery in patients from the TDT group. The tube was fixed with a skin suture and connected to a drainage bag. TDT was planed to remove 3-7 days after surgery and early removal was allowed if the patient experienced intolerable pain.

with TDT

After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.

without TDT

Tong weidong, Professor

The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium \& low rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for deduce the rate. There were several studies, but most of them were not randomized controlled trial (RCT) studies. There was only one RCT study with enough samples, but it was designed for open anterior resection, and the patients underwent diverting stoma were excluded, so there was the selection bias. LAR now is thought to been with the same effect, and it is safe and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic leakage after LAR for medium \& low rectal cancer is needed.

Patients were randomly assigned to two groups, the TDT and non-TDT group after the laparoscopic LAR and DST procedure was decided during operation. Randomization was obtained through a computer-generated random number sequence allocation. Surgeon blinding was performed to ensure all the intraoperative decisions made by the surgeon were not interfered with by the grouping. All the operative procedures fully complied with the guideline for the diagnosis and treatment of colorectal cancer and the technique of total mesorectal excision (TME). The preservation of the left colonic artery was judged by the surgeon according to his own experiences and assessment of the patient's conditions. When the anastomosis was accomplished, the discretion of DS construction was made by the surgeon based on assessing the risk factors of AL. Pelvic drainages were used in all cases in this study. After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results.

Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer

The Use of the Transanal Drainage Tube for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Medium & Low Rectal Cancer

DT-related adverse events : iatrogenic colonic perforations

The primary endpoint was the AL within 30 days after surgery. AL is defined when the following symptoms were noticed: abdominal pain, fever, peritonitis, leukocytosis, procalcitonin (PCT) or c-reactive protein (CRP) increase, discharge of feces, pus, or gas from the drainage or vagina, septicemia with pelvic abscess. All clinically suspicious symptoms were confirmed by digital rectal examination, computed tomography (CT) scan or surgery when necessary. The severity grading of AL was defined according to the International Study Group of Rectal Cancer. In the present study, AL was referred to grade B and C, asymptomatic AL (grade A) was not considered because no active therapeutic intervention was required.

The grades of AL, including grade B, grade C. The severity grading of AL is defined according to the International Study Group of Rectal Cancer

Postoperative pain score. Numerical Rating Scale (NRS) for pains is used to assess the anal postoperative pain score of patients in the TDT group. NRS is the simplest and most commonly used scales for pain evaluation.The numerical scale is most commonly 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. (for the details, please see the literature below FERREIRA-VALENTE M A, PAIS-RIBEIRO J L, JENSEN M P. Validity of four pain intensity rating scales\[J\]. Pain. 2011, 152(10): 2399-2404)

Third Military Medical University

Director of department of gastric and colorectal surgery, Daping Hospital

Intraoperative verdye green iv administration to visualize blood supply to the anastomosis

No administration of verdye green intraoperatively

intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection

Verdye Green

Pawel Bogacki

The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.

Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection

Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line

Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery

Jagiellonian University

Principle Investigator

Patients with CuRC undergoing laparoscopic colectomy or anterior resection in day surgery center.

Patients with CuRC who meet the standards will be assigned to day surgery center for surgery

Day surgery

Ziqiang Wang

To evaluate the feasibility and safety of laparoscopic colectomy and anterior resection for patients with colon/upper rectal cancer (CuRC) in day surgery center. Patients with colon or upper rectal cancer who meet the standards of day surgery will be enrolled, and laparoscopic radical resection of tumor will be performed in day surgery center. Perioperative outcomes of these patients and reasons for transferring to inpatient ward will be recorded prospectively.

At present, with the development of laparoscopic surgery and the application of rapid rehabilitation, colorectal surgery has made great progress . At the same time, the application of evidence-based surgery and multimodal anesthesia in postoperative rehabilitation has accelerated the postoperative recovery. Moreover, several previous studies have shown that the implementation of ambulatory colorectal surgery can reduce the incidence of postoperative complications and shorten hospital stay. With the continuous development of rehabilitation surgery, the hospitalization time of colorectal surgery has been gradually shortened. In addition, studies had preliminarily proved the feasibility, safety and repeatability of outpatient colectomy and showed that 30% of patients with elective colectomy can be completed in outpatient department.

Therefore, the investigators designed the clinical pathway of day surgery for patients screened by outpatient department, so that these patients can complete laparoscopic radical resection of colon cancer or high rectal cancer in the day surgery center.

The aim of this study is to evaluate the feasibility and safety of day surgery center for patients with colon/upper rectal cancer (CuRC). Patients meet the inclusion criteria and exclusion criteria will be assigned to day surgery center to perform radically laparoscopic colectomy or anterior resection. Outcomes of interests including incidence of transfer to inpatient ward, readmission, perioperative adverse events will be recorded prospectively.

Evaluation of Short-term Outcomes of Day Surgery for Patients With CuRC

Evaluation of Short-term Outcomes of Laparoscopic Radical Resection for Patients With Colon and Upper Rectum in Day Surgery Center

The incidence of patients who did not transfer to community hospital according to the plan after operation, and the causes of this situation.

From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision

including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding, and so on.

Expense for disease treatment during hospitalization

The proportion of patients who are re-hospitalized for postoperative adverse events within 90 days after discharge in all subjects.

Death rate within 90 days after surgery in all patients after operation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection	NCT01339273	Colonic Cancer Rectal Cancer Colonic Diverti... Ulcerative Coli...	Ultrasound guid... Local anaesthet...	18 Years -	Oxford University Hospitals NHS Trust
Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer	NCT02686567	Anastomotic Lea... Rectal Neoplasm...	with TDT without TDT	18 Years - 80 Years	Third Military Medical University
Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum	NCT05263336	Rectal Cancer	Verdye Green	-	Jagiellonian University
Evaluation of Short-term Outcomes of Day Surgery for Patients With CuRC	NCT04646915	Colorectal Canc...	Day surgery	18 Years -	West China Hospital
Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer	NCT02686567	Anastomotic Lea... Rectal Neoplasm...	with TDT without TDT	18 Years - 80 Years	Third Military Medical University

Spots Global Cancer Trial Database for laparoscopic anterior resection