Primary Anastomosis After Left Colectomy in Emergency Cases
Phase: NA
Conditions: Complete Obstruction
Sponsor: Ain Shams University

      
    
   
1 | P a g e   
   
   
   
   
PROTOCOL OF A THESIS FOR PARTIAL FULFILMENT OF MD DEGREE IN   
GENERAL SURGERY   
   
Title of the Protocol: Primary Anastomosis After Left Colectomy in Emergency   
Cases: Clinical Trial   
  
Postgraduate Student: Asmaa Ali Zaki   
Degree: M.Sc. Of General surgery  
   
   
   
   
DIRECTOR: prof. DR /Tarek Youssef Ahmed   
Academic Position: professor of general surgery   
Department:  General Surgery Department, Faculty of Medicine, Ain shams University.   
   
   
Co-DIRECTOR: Asst. Prof. Dr /Ahmed Aly Khalil   
Academic Position: associate professor of general surgery Department:   
General Surgery Department, Faculty of Medicine, Ain shams University.   
   
   
Co-DIRECTOR: Dr /Ibrahim Magid Abdel Maksoud   
Academic Position: lecturer of general surgery   
Department:  General Surgery Department, Faculty of Medicine, Ain shams University.   
            NCT number: IRB 00006373 
       Approval of the study: 11/2/2024 
 
   
   
Faculty of medicine   
Ain shams university   
2024   

      
    
   
2 | P a g e   
   
   
   
   
        What is already known on this subject? AND What does this 
study add?    
           Colorectal emergencies are among the most frequent in the field of abdominal 
surgery [1]. Colon perforation can cause severe sepsis, with subsequent multiorgan 
dysfunction, but colonic intestinal occlusions or hemorrhages are also clinical 
scenarios that should not be underestimated, as they might lead to life-threatening 
conditions for the patient [2]. The principal emergencies related to colorectal diseases 
are intestinal obstruction, hemorrhage, and perforation. Intestinal obstruction is the 
most frequent in the literature [4]   
          Treatment options for emergency cases with left colon pathology are diverse 
and controversial. Conventionally, primary resection with end stoma formation has 
been highly preferred to treat emergency left-sided colon presented in an emergency 
setting[5].Although the operative approach with primary resection with end stoma is 
considered the safest option due to the absence of anastomotic complications[4], 
reported cases of primary resection and anastomosis without lavage have appeared in 
western literature[6]. outcomes of primary resection and anastomosis have been 
reported to be comparable to those of Hartman Procedure [7,8].   
          Primary resection and anastomosis for left-sided colonic emergencies is 
currently gaining acceptance even in the elderly. This is in sharp contrast to the 
traditional concept of multistage refunctioning colostomy and resection [3,4] 
However, in some reported series, on-table antegrade irrigation was performed. While 
decompression may be desirable, there is some evidence that cleaning the colon of 
fecal matter does not ensure anastomotic integrity [6,9]   
   
   
           The aim of this study is to know the results of primary anastomosis after left 
colectomy in emergency cases and corresponding to the including criteria regarding 
early post operative complications as surgical site infection, ileus, incidence of 
leakage, restoration of bowel movement and hospital stay and late complication as 
rate of readmission within one month from the time of intervention.    

      
    
   
3 | P a g e   
   
  
         
   
1. INTRODUCTION/ REVIEW    
      According to the latest global cancer burden data released by the International 
Agency for Research on Cancer of the World Health Organization in 2020, incidence 
of colorectal cancer ranks third in terms of incidence among all cancers, accounting 
for approximately 10% of new cancer cases globally. Moreover, it has escalated to the 
second leading cause of cancer-related deaths worldwide [1]. Obstruction is one of the 
most common complications of colorectal cancer. It also constitutes a significant 
percentage of emergency department admissions [2].   
          Treatment options for left-sided obstructive colon cancer are diverse and 
controversial. Conventionally, primary tumor resection with end stoma formation has 
been highly preferred to treat emergency left-sided colon presented in an emergency 
setting[5].Although the operative approach with primary tumor resection with end 
stoma is considered the safest option due to the absence of anastomotic 
complications[4], the two-stage operation is complex and may significantly reduce 
patient quality of life, diverting stoma is another operative procedure for damage 
control in acute left-sided colonic emergency . The formation of a diverting stoma is 
followed by the second-stage operation of primary tumor resection with or without 
colostomy closure. Stoma closure can take place at a third stage. [6]Other  Reported 
cases of primary resection and anastomosis without lavage have appeared in Western 
literature[6] .   
       Different techniques can be used to perform colonic and rectal anastomosis, 
namely handsewn, stapled, or compression. The handsewn and stapled techniques are 
the most commonly used, although associated with the idea that the introduction of 
foreign materials can injure the intestinal tissue and trigger an inflammatory response 
[5]. Despite handsewn anastomosis being a traditional technique, stapled anastomosis 
has become very attractive due to its ease implementation. By its side, compression 
anastomosis involves the use of devices, such as clips and rings, to perform an end to-
end sutureless anastomosis [5].   
 
  
  
   

      
    
   
4 | P a g e   
   
   
2. AIM/ OBJECTIVES    
        The aim of this study is to know the results of primary anastomosis after left 
colectomy in emergency cases regarding early post operative complications as 
surgical site infection, ileus, incidence of leakage, restoration of bowel movement and 
hospital stay and rate of readmission within one month from the time of intervention.  
   
 
 
3. METHODOLOGY:     
 
 
 
 
 
 
 
 
 
 
 

      
    
   
5 | P a g e   
   
    
• Type of Study: one arm clinical trial following the SPIRIT guidelines   
• Study Setting This study will be conducted at Ain Shams University 
Hospitals. Approval of the Ethical Committee and written informed consent 
from all participants will be obtained.   
o Study period: Our study will be conducted over a period of 
12monthes, starting from the date of approval of the protocol 
by the faculty and the university committee.   
o Study Population  
 Inclusion Criteria:    
1. patient presented to emergency department with Obstructed left colon.  
2. Patients age from 18 years old to 80 years old.   
3. decision of laparotomy is taken.   
4. the intraoperative conditions are favorable to anastomosis (Good vascularity, 
no sever sepsis, no marked tissue edema, no thickened peritoneum).   
5. patient accepted to share in the study.   
   
Exclusion Criteria:   
1. Severe diffuse peritonitis (peritoneal thickening, thickened bowel 
loop, severe Tissue edema and pyogenic membrane)   
2. Marked Decreased tissue vascularity due to distension.   
3. Irresectable mass    
4. Rectal mass    
5. Patient who refusing the study.    
o Sampling Method: convenience sample (according 
to Inclusion criteria)   
o Sample Size: 37 patients.      
o Ethical Considerations  
   

      
    
   
6 | P a g e   
   
Informed consent: Informed consent from patients who are invited to 
participate in the research.     
 Confidentiality: All patients' data is confidential, and they will not be 
mentioned by name in any published paper.   
Right to refuse or withdraw: Patients have the right to refuse joining the 
research or withdraw at any time without   affecting their chances to receive 
the traditional therapy at any time.    
  
•   
Study Interventions    
1. History taking    
2. Full examination    
3. CBC, Serum Creatinine, Liver enzymes, PT PTT, Virology, ABG, Serum 
Albumin    
4. Ryle in obstructed cases    
5. Pelviabdominal ultrasonography    
6. Abdominal x ray, pelviabdominal computed tomography 
 7. Iv fluid    
8. Preoperative antibiotic    
9. Midline exploration (laparotomy) to the patients who were diagnosed with 
left colon pathology.   
10. Peritoneal lavage    
11. Assessment of the peritoneal sepsis, bowel vascularity, bowel edema, bowel 
distension then resection of diseased part (sigmoid and left colon) and stapled 
primary anastomosis (stapled using circular stapler 31 or 33) or hand sewn 
using vicryl 3/0 with second reinforcement interrupted suture using vicryl 
3/0).  
   
   
   
   
• Statistical Analysis: all data will be recorded, entered, and analyzed cohort 
study following the SPIRIT guidelines.   
   
        
     

      
    
   
7 | P a g e   
   
4-Referances 
1.International Agency for Research on Cancer. Latest global cancer data: cancer 
burden rises to 19.3 million new cases and 10.0 million cancers. deaths in 2020. 
https://www.iarc.fr/fr/news-events/latest-global-cancer-data-cancer-burden-risesto19-
3-million-new-cases-and-10-0-million-cancer-deaths-in-2020. Accessed 16 Dec 2020.   
2.Baer C, Menon R, Bastawrous S and Bastawrous A. Emergency presentations of 
colorectal cancer. Surg Clin North Am. 2017; 97:529–45.   
3. 
Naraynsingh V and Ariynanayagam DC. Obstructed left colon: one-stage 
surgery in a developing country. J. R. Coll. Surg. Edinb. 2019; 35: 360 − 1.   
4. 
Poon RTP, Law WL, Chu KW and Wong J. Emergency resection and primary 
anastomosis for left sided obstructing colorectal carcinoma in the elderly. Br. J. Surg. 
2018; 85: 1539 − 42.   
5. 
Neutzling CB, Lustosa SA, Proenca IM, da Silva EM and Matos D (2012) 
Stapled versus handsewn methods for colorectal anastomosis surgery.   
6. 
Irving AD and Scrimgeour D. Mechanical bowel preparation for colonic 
resection and anastomosis. Br. J. Surg. 2017; 74: 580 − 1.   
7.Banerjee S, Leather AJ, Rennie JA, Samano N, Gonzalez JG, et al. Feasibility, and 
morbidity of reversal of Hartmann’s. Color Dis. 2015; 7:454–459.   
8.Dudley HAF, Radcliffe AG and Mcgweehan D. Intraoperative irrigation of the colon 
to permit primary anastomosis Br. J. Surg. 2019; 67: 80 − 1.   
9.Carty NJ and Ravichandran D. The management of malignant large bowel 
obstruction. Recent Adv. Surg. 2018; 19: 1 – 8. 
    
    
   
   
   
 
 
 
 
 
 
  

      
    
   
8 | P a g e   
   
   
                                                                                     Research Guidelines   
According to EQUATOR Network   
(Enhancing the Quality and Transparency Of health Research)   
Type of Research (9)   
Guidelines   
Study Protocol Clinical  
Trials   
   
 SPIRIT     
Systematic Review/Meta-analysis   PRISMA   
Observational Study   
STROBE   
Cohort Study    
STROCSS   
Diagnostic/Prognostic Study    
STARD   
Case Report   
CARE   
Clinical Practice Guidelines    
AGREE RIGHT   
Quality Improvement    
SQUIRE 2.0   
Animal Studies    
ARRIVE   
    
 SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials   
PRISMA-P = Preferred Reporting Items for Systematic Reviews and Meta-Analyses  
Protocols   
PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analyses   
STROBE = Strengthening the Reporting of Observational Studies in Epidemiology   
STROCSS = Strengthening the Reporting of Cohort Studies in Surgery   
STARD = Standards for Reporting Diagnostic accuracy studies   
CARE = Case Reports Guidelines   
AGREE = Appraisal of Guidelines for REsearch & Evaluation   
RIGHT = Reporting Items for Practice Guidelines in Healthcare   
SQUIRE 2.0 = Standardsfor QUalityImprovement Reporting Excellence ARRIVE = 
Animal Research: Reporting of In Vivo Experiments   

      
    
   
9 | P a g e   
   
   
   
    
    
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and 
related documents*    
   
Section/item   Item Description    
No    
   
Administrative information    
Title   1   Descriptive title identifying the study design, population, interventions, and, 
if applicable, trial acronym    
Trial registration 2a   Trial identifier and registry name. If not yet registered, name of 
intended registry    
   
2b   All items from the World Health Organization Trial  
Registration Data Set    
Protocol version 3    
Date and version identifier    
Funding    
4    
Sources and types of financial, material, and other support   Roles  
 
and 5a   
Names, affiliations, and roles of protocol contributors   responsibilities  5b   
 
Name and contact information for the trial sponsor    
   5c   Role of study sponsor and funders, if any, in study design; collection, 
management, analysis, and interpretation of data; writing of 
the report; and the decision to submit the report for 
publication, including whether they will have ultimate 
authority over any of these activities    
   5d   Composition, roles, and responsibilities of the coordinating centre, steering 
committee, 
endpoint 
adjudication 
committee, 
data 
management team, and other individuals or groups overseeing 
the trial, if applicable (see Item 21a for data monitoring 
committee)    

      
    
   
10 | P a g e   
   
Introduction       
    
Background and 6a   Description of research question and justification for rationale     
 
undertaking the trial, including summary of relevant studies (published and 
unpublished) examining benefits and harms for each intervention    
    
6b   Explanation for choice of comparators    
Objectives    
7    
Specific objectives or hypotheses    
Trial design    8    
Description of trial design including type of trial (eg, parallel  
group, crossover, factorial, single group), allocation ratio, and framework (eg, 
superiority, equivalence, noninferiority, exploratory)    
Methods: Participants, interventions, and outcomes    
Study setting    9  Description of study settings (eg, community clinic, academic 
hospital) and list of countries where data will be collected. 
Reference to where list of study sites can be obtained    
Eligibility 
criteria    
10  Inclusion and exclusion criteria for participants. If applicable, 
eligibility criteria for study centres and individuals who will 
perform the interventions (eg, surgeons, psychotherapists)    
Interventions    11a  Interventions for each group with sufficient detail to allow 
replication, including how and when they will be administered 
  
11b  Criteria for discontinuing or modifying allocated interventions 
for a given trial participant (eg, drug dose change in response 
to harms, participant request, or improving/worsening 
disease)    
  
11c  Strategies to improve adherence to intervention protocols, and 
any procedures for monitoring adherence (eg, drug tablet 
return, laboratory tests)    
  
11d  Relevant concomitant care and interventions that are  permitted 
or prohibited during the trial    
Allocation:    
       
Sequence   
16a  Method of generating the allocation sequence (eg, generation   
computergenerated random numbers), and list of any factors for stratification. To 
reduce predictability of a random sequence, details of any planned restriction (eg, 
blocking) should be provided in a separate document that is unavailable to those 
who enrol participants or assign interventions    

      
    
   
11 | P a g e   
   
Outcomes   12  Primary, secondary, and other outcomes, including the specific 
measurement variable (eg, systolic blood pressure), analysis 
metric (eg, change from baseline, final value, time to event), 
method of aggregation (eg, median, proportion), and time 
point for each outcome. Explanation of the clinical relevance 
of chosen efficacy and harm outcomes is strongly 
recommended    
Participant 
timeline    
13    Time schedule of enrolment, interventions (including any 
runins and washouts), assessments, and visits for participants. 
A schematic diagram is highly recommended (see Figure)    
Sample size    
14    Estimated number of participants needed to achieve study 
objectives   and how it was determined, including clinical and 
statistical assumptions supporting any sample size calculations  
Recruitment    
15    Strategies for achieving adequate participant enrolment to   
reach target sample size    
Methods: Assignment of interventions (for controlled trials)    
 Allocation  16b  Mechanism of implementing the allocation sequence (eg, 
concealment central telephone; sequentially numbered, opaque, sealed mechanism  
envelopes), describing any steps to conceal the sequence until interventions are 
assigned    
Implementation 16c  Who will generate the allocation sequence, who will enrol 
participants, and who will assign participants to interventions   
Blinding   
(masking)    
17a  Who will be blinded after assignment to interventions (eg, trial 
participants, care providers, outcome assessors, data 
analysts), and how    
   
17b  If blinded, circumstances under which unblinding is   
permissible, and procedure for revealing a participant’s  
allocated intervention during the trial    
Methods: Data collection, management, and analysis    
Data collection 18a  Plans for assessment and collection of outcome, baseline, and 
methods  other trial data, including any related processes to promote data quality (eg, 
duplicate measurements, training of assessors) and a description of study instruments 
(eg, questionnaires, laboratory tests) along with their reliability and validity, if 
known. Reference to where data collection forms can be found, if not in the protocol     
18b  Plans to promote participant retention and complete followup, including list of  

      
    
   
12 | P a g e   
   
any outcome data to be collected for participants who 
discontinue or deviate from intervention protocols    
Data 19 Plans for data entry, coding, security, and storage, including any management   
related processes to promote data quality (eg, double data entry; range checks for data 
values). Reference to where details of data management procedures can be found, if 
not in the protocol    
Statistical 
methods    
20a  Statistical methods for analysing primary and secondary 
outcomes. Reference to where other details of the statistical 
analysis plan can be found, if not in the protocol    
   
20b  Methods for any additional analyses (eg, subgroup and adjusted 
analyses)    
   
20c  Definition of analysis population relating to protocol  
nonadherence (eg, as randomised analysis), and any statistical 
methods to handle missing data (eg, multiple imputation)    
Methods: Monitoring   
Data monitoring 21a  Composition of data monitoring committee (DMC); summary 
of its role and reporting structure; statement of whether it is 
independent from the sponsor and competing interests; and 
reference to where further details about its charter can be 
found, if not in the protocol. Alternatively, an explanation of 
why a DMC is not needed    
   
21b  Description of any interim analyses and stopping guidelines, 
including who will have access to these interim results and 
make the final decision to terminate the trial    
Harms    
22  Plans for collecting, assessing, reporting, and managing 
solicited and spontaneously reported adverse events and other 
unintended effects of trial interventions or trial conduct    
Auditing    
23    
Frequency and procedures for auditing trial conduct, if any, 
and whether the process will be independent from   
investigators and the sponsor    
Ethics and dissemination    
Research ethics  24 Plans for seeking research ethics committee/institutional approval  
review board (REC/IRB) approval    
Protocol  25 Plans for communicating important protocol modifications amendments   
(eg, changes to eligibility criteria, outcomes, analyses) to   
  
relevant  parties  (eg,  investigators,  REC/IRBs,  trial   

      
    
   
13 | P a g e   
   
participants, trial registries, journals, regulators)    
Consent or assent 26a  Who will obtain informed consent or assent from potential trial  
participants or authorised surrogates, and how (see Item 32)    
    
26b  Additional consent provisions for collection and use of   
participant data and biological specimens in ancillary studies, if  
applicable    
Confidentiality  27    How personal information about potential and enrolled  
participants will be collected, shared, and maintained in order to  
protect confidentiality before, during, and after the trial  Declaration of 28   Financial 
and other competing interests for principal interests    investigators for the overall trial 
and each study site    
Access to data  29  Statement of who will have access to the final trial dataset, and 
disclosure of contractual agreements that limit such access for 
investigators    
Ancillary and 30  Provisions, if any, for ancillary and post-trial care, and for post-trial 
care  compensation to those who suffer harm from trial participation Dissemination 
31a  Plans for investigators and sponsor to communicate trial policy  results to 
participants, healthcare professionals, the public, and other relevant groups (eg, via 
publication, reporting in results databases, or other data sharing arrangements), 
including any publication restrictions    
  31b  Authorship eligibility guidelines and any intended use of professional writers    
  31c  Plans, if any, for granting public access to the full protocol, participantlevel 
dataset, and statistical code    
Appendices    
    
    
Informed consent 32 Model consent form and other related documentation given to 
materials  participants and authorised surrogates    
Biological  33  Plans for collection, laboratory evaluation, and storage of specimens  
biological specimens for genetic or molecular analysis in the current trial and for 
future use in ancillary studies, if applicable    
   
*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 
2013 Explanation & Elaboration for important clarification on the items. Amendments 
to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the 
SPIRIT Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 
3.0 Unported” license.    

      
    
   
14 | P a g e   
   
    
     
  
Informed consent form for patients who are invited to  participate in the research 
 
Research title:   
Primary Anastomosis After Left Colectomy in Emergency cases. 
Introduction and aim of the work:  
According to the latest global cancer burden data released by the International Agency 
for Research on Cancer of the World Health Organization in 2020, incidence of 
colorectal cancer ranks third in terms of incidence among all cancers, accounting for 
approximately 10% of new cancer cases globally. Moreover, it has escalated to the 
second leading cause of cancer-related deaths worldwide. Obstruction is one of the most 
common complications of colorectal cancer. It also constitutes a significant percentage 
of emergency department admissions.   
          Treatment options for left-sided obstructive colon cancer are diverse and 
controversial. Conventionally, primary tumor resection with end stoma formation has 
been highly preferred to treat emergency left-sided colon presented in an emergency 
setting].Although the operative approach with primary tumor resection with end stoma 
is considered the safest option due to the absence of anastomotic complications], the 
two-stage operation is complex and may significantly reduce patient quality of life, 
diverting stoma is another operative procedure for damage control in acute left-sided 
colonic emergency . The formation of a diverting stoma is followed by the second-
stage operation of primary tumor resection with or without colostomy closure. Stoma 
closure can take place at a third stage. Other Reported cases of primary resection and 
anastomosis without lavage have appeared in Western literature.   
      Different techniques can be used to perform colonic and rectal anastomosis, namely handsewn, 
stapled, or compression. The handsewn and stapled techniques are the most used, although 
associated with the idea that the introduction of foreign materials can injure the intestinal tissue and 
trigger an inflammatory response .    
     Despite handsewn anastomosis being a traditional technique, stapled anastomosis has become 
very attractive due to its ease implementation. By its side, compression anastomosis involves the 
use of devices, such as clips and rings, to perform an end to-end sutureless anastomosis. 

      
    
   
15 | P a g e   
   
The aim of this study is to know the results of primary anastomosis after left colectomy in 
emergency cases regarding early post operative complications as surgical site infection, ileus, 
incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission 
within one month from the time of intervention. 
Place of work:  
This study will be conducted at (General surgery department), Ain Shams University Hospitals.  
 
Number and selection of participants:  
• 
37 Patients  
• 
Study Population:  
• 
Inclusion criteria:  
1. patient presented to emergency department with Obstructed left colon.  
2. Patients age from 18 years old to 80 years old.   
3. decision of laparotomy is taken.   
4. the intraoperative conditions are favorable to anastomosis (Good vascularity, no sever 
sepsis, no marked tissue edema, no thickened peritoneum).   
5. patient accepted to share in the study.   
 
 
Exclusion Criteria:   
6. Severe diffuse peritonitis (peritoneal thickening, thickened bowel loop, severe 
Tissue edema and pyogenic membrane)   
7. Marked Decreased tissue vascularity due to distension.   
8. Irresectable mass    
9. Rectal mass    
10. Patient who refusing the study.    
 
Plan of work:  
• 
Patients will be selected according to previously discussed inclusion and exclusion criteria.  
• 
Informed consent will be taken from the patients to participate in the study.  
 
Benefits Expected from the study:  

      
    
   
16 | P a g e   
   
Improvement of patient general condition in one stage surgery instead of multiple stage surgery and 
avoid colostomy and its complication.  
Improvement the patient quality of life  
 
Conducting the consent:  
- Personal interview with explanation of the study and its benefits.  
 
Risks and complications:  
Complication of general anesthesia or other surgical intervention 
Confidentiality:  
You will deal in complete confidentiality, and no one has right to read your patient medical 
information except the main researcher. After the research is complete, you will be informed 
regarding your patient's research results and further information regarding your patient's health 
status.  
 
Right to refuse or withdraw:  
You have the right to withdraw at any point of the study without any excuses or negative 
consequences.  
  
Contact information:   
 Phone number: Asmaa Ali Zaki 
Main operator: 01021699220 
 Main supervisor: Prof. Dr/Tarek Yousef 
 
Certificate of consent:  
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask 
questions about the procedure and any question that I ask to have been answered with satisfaction. 

      
    
   
17 | P a g e   
   
I consent voluntarily to participate in this study and understand that I have the right to withdraw 
from the study at any time without, in any way, affecting my medical care.  
● Name of the patient:  
● Signature of legal guardian:  
● Or participant:  
● Identify number or fingerprint:  
● Date:  
I have accurately read or witnessed the accurate reading of the consent to the potential participant. 
The individual has had the opportunity to ask questions. I confirm that the individual has given 
consent freely.  
● Name of the researcher:   
● Signature of the researcher:  ● Date:   
 
This proposal has been reviewed and approved by Ethical Committee of Scientific research, which 
is a committee whose task is to make sure that research participants are protected from harm.  
If you wish to find more about Ethical Committee of Scientific research, contact:  
● Name:   
● Address:  
● Telephone number: