LapEmerge-trial: laparoscopic approach for emergent colon resection; a multicentre, open label, randomized controlled trial.

doi:10.21203/rs.3.rs-3345819/v1

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Research Article

LapEmerge-trial: laparoscopic approach for emergent colon resection; a multicentre, open label, randomized controlled trial.

https://doi.org/10.21203/rs.3.rs-3345819/v1

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Background

Because of faster recovery and less morbidity, laparoscopy has become the golden standard in elective colorectal surgery both for benign and malignant disease. A substantial portion of colorectal surgery is however carried out in emergency settings and most of the emergency resections are still performed open. The aim of this study is to compare laparoscopic versus open approach for emergency colorectal surgery.

Method/Design

This is a multicenter prospective randomized controlled trial including adult patients presenting with a condition requiring emergency colorectal resection.

Discussion

Previous studies cautiously recommend wider use of laparoscopy in emergency colorectal resections, but all earlier reports are retrospective, mostly single center studies and have limited number of patients. There might be unpredictable risks with laparoscopy yet not reported because of infrequent use of the technique. A prospective randomized controlled trial is urgently needed to assess the safety of laparoscopy as well as advantages and disadvantages between open and laparoscopic emergency surgery.

Trial registration number: NCT05005117, URL: https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05005117

Laparoscopy

Emergency surgery

Colon

Colon cancer

Large bowel obstruction

Randomized controlled trial

The first laparoscopic colon resection for colorectal cancer was performed in 1990. In the beginning there were concerns about achieving adequate oncological results with laparoscopic technique. Additionally there were considerable amounts of port site metastases in the 1990´s which by time diminished along with the development of laparoscopic instrumentation². Quite soon after initial doubts, laparoscopy was proven to be both safe and equal to open surgery regarding oncological results^3–5. Further, patient recovery was faster, postoperative ileus occurred less often and overall morbidity was lower^5–7. Therefore, laparoscopy proved to be cost efficient⁸.

Today, laparoscopic colorectal resections have become well established in elective surgery but the role of laparoscopy in emergency operations remains uncertain^{9, 10}. It may be expected that the same beneficial factors achieved by mini-invasive techniques in elective surgery also advocate the use of laparoscopy in emergency operations^11–13. There are, however, several concerns regarding laparoscopy in emergency settings. The operations are technically more challenging due to distortion of normal anatomy and the presence of dilated vulnerable bowel¹⁴. The intra-abdominal lavage in inflammatory processes might be less effective¹⁵ and the operative time is longer which could be a disadvantage to the critically ill patient¹⁶.

Approximately 10–20% of colorectal resections are carried out as emergency operations which are associated with higher risk for in-hospital mortality, two times higher risk for reoperation and three times higher risk for failure to rescue, compared to elective surgery^17–19. The type of complications varies greatly depending on whether the operation has been elective or emergent which most likely also reflect the type of technical approach. For an example, fascial rupture is almost three times more common after emergency operation¹⁹. In many other entities demanding emergency surgery, the laparoscopic approach has proven to diminish both morbidity and mortality²⁰ and can therefore be assumed to do so also in colorectal surgery.

As many as 15–20% of patients with colorectal cancer present with obstruction¹⁷ and it is important that the oncologic results doesn´t get worse with implementing a new surgical technique. There are no previous reports assessing oncologic outcome between laparoscopic and open approach in emergency operations. In the evaluation of oncologic adequacy of surgical approach, the pathology report and the quality of the surgical specimen are of utmost importance. Classifying the surgical specimen is only possible in a prospective study design. Benz et al proposed a new classification system for surgical specimen that facilitates this evaluation²¹.

Previous reports on laparoscopy for emergency colorectal resections cautiously propose using laparoscopy more often in emergency settings but most of the reports are retrospective, register based or single center studies with limited number of patients^22–24. The aim of this study is to evaluate whether patients benefit from the laparoscopic approach in emergency colorectal surgery, both in benign and malignant disease.

Objectives

The objective of the “Laparoscopic approach for emergent colon resection; a multicenter, open label, randomized controlled trial, protocol”-trial is to evaluate whether patients benefit from the laparoscopic approach in emergency colorectal surgery, both in benign and malignant disease.

Our hypothesis is that the same beneficial effects of laparoscopy seen in elective surgery and in other entities needing emergency surgery, will also apply for emergency colorectal surgery. These effects are lower overall postoperative morbidity, shorter length of stay, less post-operative ileus, less postoperative pain, less wound complications, and lower risk of mortality.

For oncologic patients our hypothesis is that the laparoscopic approach is superior to the open approach, partially because of faster recovery associated with increased access to oncologic treatment and partially because in laparoscopy the intra-operative circumstances need to be optimized to mimic the elective situation leading to good visualization and standardized approach.

Trial design

“Laparoscopic approach for emergent colon resection; a multicenter, open label, randomized controlled trial, protocol” is a prospective, randomized, controlled, multicenter study comparing laparoscopic and open approach for emergency colorectal resections. The main outcome is post-operative morbidity. The trial is independent from any kind of industrial sponsorship.

Study setting

This study will be carried out in six university or central hospitals in Finland: Päijät-Häme Central Hospital, Pohjois-Karjala Central Hospital, Jorvi Helsinki University Hospital, Kanta-Häme Central Hospital, Keski-Suomi Central Hospital and Oulu University Hospital.

Eligibility criteria

Inclusion criteria

The patient has a condition necessitating emergency colorectal resection

Age 18 years or older

The patient is competent to make decision to consent

Signed informed consent

Exclusion criteria

The patient´s condition is due to trauma

Simultaneous acute pancreatitis

The need of resection is due to a complication of a previous procedure, i.e. reoperation

Simultaneous ruptured aortic aneurysm or ruptured aortic aneurysm as the underlying cause of need for surgery

All patients arriving in the emergency room and diagnosed with a condition requiring emergency colorectal resection will be considered for inclusion. After receiving proper information on the possible advantages and disadvantages of intervention, and after voluntarily signing the informed consent form, the subjects will be enrolled in the trial. The written consent is obtained by a member of the research group and a copy of it is given to the patient. After enrolment the patient is randomized into either open or laparoscopic surgery. The procedure is carried out or closely supervised by a specialist in gastrointestinal surgery experienced in colorectal resections. Patients considered but not for filling the inclusion criteria or patients with at least one exclusion criteria will not be enrolled. These patients and reasons for exclusion will be documented. The post-operative care and follow-up is conducted according to normal praxis and the case report form is filled. After 90 days from surgery, patients are requested to fill the Gastrointestinal Quality of Life Index (GIQLI) questionnaire which is the only deviation from normal follow-up. The GIQLI questionnaire is delivered and received by post with no additional cost for the patients. Enrolled patients will not be exposed to any additional visits to the hospital, radiation, or medical procedures. Oncological patients’ follow up is also arranged according to normal follow-up schedule.

If, at any point the allocated intervention needs to be modified or even discontinued because of patient safety or any other reason, the circumstances and reasons will be accurately documented, and the patient will be informed. For an example if the patient’s condition changes making the patient unfit for surgery in general exclusion takes place. In case of conversion during the operation circumstances will be carefully documented but the patient can continue to participate.

Surgical technique

The operations will be conducted according to the requirements of the underlying medical condition of the patient, for an example whether the reason for surgery is perforation or obstruction.

For obstruction in the right-sided colon or transversum the aim is primary resection and anastomosis. The anastomosis is done extracorporeally to avoid fecal contamination. In case of perforation with wide contamination in the critically ill patient solely ostomy is considered instead of anastomosis or with a defunctioning stoma. For obstruction in the left sided colon the aim is also to conduct primary resection with anastomosis. Because of the elevated risk for anastomotic leakage, a defunctioning loop transversostomy or ileostomy will be considered even in the absence of perforation. Considering the clinical condition of the patient, primary resection with end colostomy is also an option.

In case of perforation and peritonitis, intra-abdominal lavage is performed. If the reason for surgery is colorectal cancer the operation is done according to CME principles.

In laparoscopic operations, decompression of the enlarged intestine is done in the beginning of the procedure by making a small incision in the planned place of specimen removal. The wound is protected by a wound protector. After making a purse-string suture a small enterotomy is done to the intestinal wall through which a suction tube is placed to decompress the bowel. After sufficient decompression the enterotomy is closed and the lid is placed on the wound protector. After this pneumoperitoneum is created and the procedure is carried out laparoscopically according to same principles as in elective surgery. In open surgery, either a midline or a horizontal incision is made, and the procedure is carried out according to normal praxis. Usually, a separate decompression is not needed. The wound is closed according to the Israelsson´s technique with slowly absorbable monofilament sutures.

If at any point of the protocol for patient safety or any another reasons the allocated intervention needs to be modified or discontinued.

Outcomes

The main endpoint of the study will be 30-days postoperative morbidity which will be evaluated by the Comprehensive Complication Index (CCI) of all patients. CCI is the sum of all complications that are weighted on their severity based on Clavien-Dindo classification (CCI=√(wC+wC2+…+wCx)/2) and has values ranging from 0-100²⁵.

The secondary endpoints of the study are as follows:

90 days mortality:

Death for any reason within 90 days of surgery (yes/no)

Surgical site infection (SSI):

SSI is defined as infections occurring up to 30 days after surgery (or up to one year after surgery in patients receiving implants) and affecting either the incision or deep tissue at the operation site. SSI are divided into Superficial incisional, deep incisional and organ/space surgical site infections²⁶.

Intensive care unit (ICU) free days:

ICU free days is defined as days alive within 30 days postoperative minus days spent in the ICU (range 0-30).

Length of stay (LOS):

LOS is defined as the time (days) between the index emergency operation and the day of discharge.

Permanent ostomy:

Permanent ostomy (yes/no) is defined as no stoma reversal within two years of operation as nearly all reversals are performed within that timeframe²⁷.

Reoperation risk:

Reoperation within 30 days after primary intervention (yes/no) and reason for reoperation. Only operations that are due to a (suspected) complication and a directly related to the primary operation is considered as a reoperation.

Bowel function:

The time (days) from operation to the first defecation.

Readmission:

Readmission within 30 days after surgery for any reason (yes/no and reason for readmission)

Quality of life (QoL):

QoL is measured by the GIQLI health survey²⁸ 90 days after surgery.

For oncological patients

Quality of surgical specimen:

All surgical specimens will be photographed according to agreed protocol. The specimen is placed on a clean surface, before opening the bowel. The mesentery is spread out for visualisation. Main vascular branches as well as the tumour are pointed out with an instrument (e.g Crile). The specimen is evaluated by an independent, blinded specialist in gastroenterological surgery. For classification of right sided colon specimen, the Benz classification will be used²¹. Left sided specimens are classified according to beforehand agreed criteria including the level of vascular ligation and quality of mesentery (Appendix 3).

Number of lymph nodes:

Both the number of retrieved lymph nodes and nodes affected by cancer are registered

Overall Survival (OS):

OS is defined as the time of the initial treatment of cancer to death caused by any reason (years)

Cancer specific survival (CSS):

CSS is defined as the time of the initial treatment of cancer to death caused by the same cancer (years).

Disease free survival (DFS):

DFS is defined as the time after initial treatment of cancer to recurrence of the cancer or death by any reason.

Pre-intervention data

Diagnosis and reason for emergency operation (Obstruction, perforation, ischemia etc).

Age, sex, BMI, ASA-classification, co-morbidity according to the Charlson comorbidity index²⁹, previous abdominal operations and medication (the usage of anticoagulation, oral cortisone or immunosuppressants).

Need for ICU treatment preoperatively (yes/no).

Intervention data

Technique (open/laparoscopic/conversion) and type of resection using the Nordic Medico-Statistical Committee (NOMESCO) Surgical Procedural codes.

Anastomosis (intra-or extracorporeal, hand-sewn or stapled) or/and ostomy (loop-ileo-or colostomy or end ileo-or colostomy). Was the anastomosis tested intraoperatively (air-water leak test/endoscopy).

Contamination (preoperative/perforation/abscess/local peritonitis/general peritonitis).

Operative time (min), time of anesthesia (min), blood loss (ml), blood transfusion (IU), intraoperative fluids (ml), the need for vasoactive drugs (noradrenaline) during the operation (yes/no).

Post-intervention data

Need for ICU treatment (days), need of naso-gastric tube (days), flatus (days), first bowel movement (days)

Pain medication:

Epidural anesthesia (days), need for opioids (days), pain medication at discharge.

LOS, discharge to home or to rehabilitation unit

All complications described and measured by the Clavien-Dindo classification

Demand for re-operation

The GIQLI questionnaire (points) 90days post-operatively

For oncological patients:

OS, CSS, DFS, adjuvant therapy (days)

Follow-up at 6 months, 1,3, -and 5 years.

In case of metastatic disease:

OS, CSS, chemotherapy (days)

If remission is achieved (days)->DFS

Participant timeline

Randomization of patients started in September 2021 at Päijät-Häme central hospital and will last for 3-4 years. The estimated enrolment schedule is presented in Table1. The progress of enrolment is assumed to vary between participating hospitals because of differences in annual caseloads of emergency colorectal diseases.

Table 1. Estimation on enrolment timeline

Table 2. Spirit Figure.

Schedule of Events	Baseline	Procedure	Postoperative monitoring during hospital stay	Discharge	30 days	90 (+60) days	1 years	2 years	3 years	5 years	Unscheduled Visit
Informed Consent	X
Need of preoperative intensive care/intensive care unit treatment	X
Demographics and medical history	X
Procedure details		X
Need of postoperative intensive care/intensive care unit treatment			X
Bowel function			X
Analgesics			X	X
Complications		X	X	X	X
The Gastrointestinal Quality of Life Index (GIQLI)						X
Mortality						X
Oncological patients: TNM-classification, adjuvant chemotherapy, chemotherapy OS, CSS, DFS*							X		X	X	X
Ostomy closure								X
Protocol Deviation	X	X	X	X	X		X		X	X	X

*OS =overall survival, CSS=cancer-specific survival, DFS =disease-free survival.

Sample size

Sample size calculations are based on previous studies reporting 48.3% 30-days post-operative morbidity after open surgery and 27.8% after laparoscopy²³. The aim of study is to show that post-operative morbidity is lower after laparoscopic surgery. Assuming α = 0.05 and a power = 80, 87 patients are needed for both groups. Assuming 10% drop-out rate of patients for 30 days follow-up period, a total of 192 patients i.e., 96 in each group is needed.

Recruitment

All subjects fulfilling the inclusion criteria will be considered to participate in the trial. An anonymous record will be kept prospectively on all subjects fulfilling the inclusion criteria but not attending, either by not consenting or for any other reason, for later assessment of selection bias.

Assignment of interventions

Allocation

Patients are randomly allocated to the study group according to a computer-generated list, compiled by a person who is not involved in the clinical care of trial patients. The randomization is performed in blocks, where the block size is six patients. A separate randomization list is created for each center. Also, a separate randomization list is created according to the indication for surgery: obst-ruction, perforation or other reason. The results of randomization are read by opening sealed envelopes in numerical order. Randomization will be performed after confirmation of patient eligibility and consenting.

Blinding

Blinding is impossible after surgery since wound size will reveal which technique was used. The independent surgeon evaluating photographed surgical specimen is however, blinded to the technique used.

Data collection, management, and analysis

Data collection methods

All data will be collected prospectively on an electronic database designed for this study.

The reasons for withdrawal will be documented carefully. The investigator will attempt to contact the subject at least three times prior to designating them as lost to follow-up. The investigator will document the date and type of attempted communication. If a subject cannot be reached during the visit window, a missed visit will be recorded; after three consecutive missed visits, the subject will be considered lost to follow-up, and a study exit form will be completed in the CRFs. Any data on subject participation and procedures until their withdrawal will be analysed within the research.

Data management

All data will be handled with utmost confidentiality. Permission for the study register has been admitted by the ethics committee of Helsinki University Hospital and further by the Päijät-Häme central hospital administration.

Data monitoring

There is no data monitoring committee named in this trial. All complications and harmful events will be carefully reported using specific CRFs, and serious events will be reported to the principal investigator immediately. As previous studies do not provide enough information on differences in recovery between open and laparoscopic approach in emergency setting, a preliminary safety analysis at 30 day follow up on 50 patients on each group will be done. Presumably laparoscopy is safer but there might also be unknow factors that affect patient recovery. Any serious concern raised at any point in the study will result in the consideration of preliminarily terminating the study. All authors will have access to the data. All raised concerns from any author or person outside the study group will be documented and assessed by authors.

Statistical methods

Analyses will be performed using SPSS (version 27 or higher) (IBM Corp., Armonk, NY, USA) for Windows. Between-group comparisons of continuous variables will be performed by Student’s t test or Mann-Whitney U test, the latter of which will be used if heterogeneous variances persist. Categorical data will be compared using χ² or Fisher’s exact test. Long term survival will be analysed using Cox regression or Kaplan-Meier´s analysis. Two-tailed p values will be reported. P-values ≤0.05 are considered significant. In case of missing data for a certain variable the case is removed from the analyses in question.

Ethics and dissemination

Research ethics approval

This study follows the Declaration of Helsinki on medical protocols and ethics, and the study’s protocol has been approved by the Ethics Committee of Helsinki University Hospital 7.4.2021 (reference number 1106/2021). The amendment for participation of Pohjois-Karjala Central Hospital was approved 30.11.2022. The amendment for participation of Keski-Suomi Central Hospital and Jorvi Helsinki University Hospital was approved 18.1.2023. The amendment for participation of Oulu University Hospital was approved 5.7.2023. Each participating hospital apply for study permission at their unit.

Protocol amendments

Important protocol modifications will be communicated to the Helsinki University Hospital Ethics Committee by amendments. All modifications will also be registered at Clinical Trials.

Confidentiality

Patient confidentiality will be strictly maintained. Patients will be pseudonymized by study identification numbers, and all data will be handled without using names or personal social security numbers. Access to patient records will be limited to the study group and the investigator-delegated study coordinator.

Mini-invasive surgery has become the golden standard in elective colorectal surgery due to faster recovery, diminished pain medication, decreased post-operative morbidity and good oncological results^{5–7, 18, 30–35}. For some reason there has not been the same enthusiasm for mini-invasive surgery in emergency settings even though presumably the same advantages in favour of laparoscopy could potentially apply. Previous studies cautiously recommend wider use of laparoscopy but as mentioned earlier, they are all retrospective, most single-center studies with small numbers of patients^{18, 24, 36–42}. In retrospective studies, comparing two different techniques, selection bias is inevitable. Some register-based studies have tried to balance the open and laparoscopic groups by propensity score methods^{18, 24, 36–42}. However, these studies still have remarkable limitations such as retrospective nature of the study, data loss, nonuniformity, selection bias, and coding errors.

There are many possible risk factors which can be attributed to laparoscopic emergency colorectal surgery, like iatrogenic bowel perforations, inadequately performed abdominal lavage, risk for contamination and poor decompression. Because laparoscopy has been infrequently used in emergency situations there might also be many unpredictable risk factors that has not yet been recognized. A theoretical disadvantage of laparoscopic technique is the use of pneumoperitoneum in critically ill patients with peritonitis-related injury of peritoneal lining. It has been shown that laparoscopy induces negative effects on peritoneal integrity, modifies its immune system, and induces peritoneal acidosis⁴³. However, the clinical meaning of these factors is not known.

In other words, there are many probable advantages in introducing laparoscopy more widely in emergency colorectal surgery but at the same time risk factors should be properly assessed.

In April 2020 Harji et all published the LaCeS-feasibility trial where safety and overall implementation of a prospective randomized controlled trial assessing laparoscopy versus open approach in emergency colorectal surgery was evaluated. Statistical analyses were not done but post-operative morbidity and mortality were somewhat lower for patients that had a laparoscopic procedure indicating that laparoscopic emergency colorectal surgery could be safe. Recruitment and patient compliance were also found to be good⁴⁴. We found the results encouraging for implementation of the LapEmerge-trial.

This is the first full-scale randomized, controlled study to compare open and laparoscopic emergency colorectal resection. This trial will provide novel information on both the short- and long-term effects and safety of laparoscopy in emergency colorectal surgery.

Trial status

Approval by the Ethics Committee of Helsinki University Hospital was received (reference1106/2021), and patient recruitment at Päijät-Häme Central Hospital started in September 2021. So far 75 patients have been enrolled. Other hospitals have started the trial during the year 2023. Recruitment is estimated to end on the 30th of September 2025. This is version 1 of the protocol.

Ethics approval and consent to participate

Helsinki University Hospital Ethics Committee approval 1106/2021. Written, informed consent to participate will be obtained from all participants.

Consent for publication

Not applicable

Availability of data and materials

Marie Grönroos-Korhonen and Jyrki Kössi have access to the final trial dataset. There are no contractual agreements limiting such access for investigators.

Competing interests

The authors declare that they have no competing interests.

Funding

The study is funded by the Helsinki University Hospital specific catchment area state research funding. The funding body has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

Authors' contributions

Marie Grönroos-Korhonen is the Chief Investigator; she conceived the study, led the proposal and protocol development. Jyrki Kössi contributed to the study conceiving, design and to development of the proposal. All authors read and approved the final manuscript.

Publication policy

The trial results will be proposed for publication in an international scientific journal.

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Attachment 1. Study subject information sheet.

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Editorial decision: Minor revision
20 Jan, 2024
Reviewers agreed at journal
20 Dec, 2023
Reviewers invited by journal
19 Dec, 2023
Editor assigned by journal
15 Dec, 2023
First submitted to journal
25 Oct, 2023

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LapEmerge-trial: laparoscopic approach for emergent colon resection; a multicentre, open label, randomized controlled trial.

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