This study was conducted at Zagazig University Hospital between October 2019 and July 2020. Only after receiving full and informed consent from each enrolled patient were included in the study. Restorative colorectal resection (LAR and ultra-LAR) for rectal cancer was included in this prospective cohort study. Patients with rectal carcinoma who underwent restorative colorectal resections with ghost (prestige or virtual) ileostomies were included in our cohort. All patients underwent a thorough physical examination and history evaluation before surgery. Preoperative colonoscopic biopsy, carcinoembryonic antigen (CEA) levels, contrast-enhanced computed tomography (CECT) of the abdomen, pelvis, and chest, and magnetic resonance imaging (MRI) of the pelvis were used to confirm the diagnosis and stage of the disease. The factors related to the GI-takedown technique were procedure time, procedural difficulties, intra- or postprocedural problems, and ease of use.
Trial's eligibility and disqualification standards
General selection
Conditions of inclusion
rectal cancer; elective low anterior resection; ≥18 years of age.
signed release of information.
Capacity to comprehend the personal implications of trial involvement on character
Criteria for exclusions
>30 kg/m2 for body mass index.
Chronic renal failure, defined as a glomerular filtration rate <30 mL/min or dialysis required, is categorized as >3 by the American Society of Anesthesiologists.
inhibition of the immune system (azathioprine; cortisone ≥40 mg/day or similar).
Anticoagulation therapy is necessary.
Significant cardiac disease includes unstable angina, congestive heart failure that is NYHA class II, unstable angina, and people who have had a myocardial infarction within the previous six months or who have undergone coronary revascularization.
Any Child-Pugh grade of liver cirrhosis
Ultralow rectal cancer refers to tumors that require transanal coloanal anastomosis or intersphincteric resection or that have a lower tumor margin <4 cm from the anal edge as determined by digital rectal examination and rigid proctoscopy.
involvement in a different experiment, including an intervention that could affect the intervention's results.
Criteria for intraoperative exclusion
partial rings of staples.
Positive test for intraoperative air bubbles.
intraoperative discoveries that, in the judgment of the particular surgeon, render a loop ileostomy necessary (e.g., intraoperative diagnosis of liver cirrhosis, acute or chronic ileus, intraoperative lesion of the rectum, urinary bladder, or vagina).
Multisegmental excision.
Patients with stage I through IV disease were included in the study, according to the American Joint Committee on Cancer criteria for rectal cancer. 23 patients with rectal carcinoma operating in elective settings, representing all age groups and both sexes, were included. Alternatively, the study eliminated patients who underwent emergency surgery due to acute intestinal obstruction, perforation, and peritonitis; furthermore, patients who were on immunosuppressive medications, had stage IV disease, and had significant hypoalbuminemia (serum albumin ~−2.5 g/dl) Furthermore excluded were patients with carcinoma rectum with underlying FAP necessitating TPC with IPAA, patients requiring restorative colorectal resections for benign illnesses, and patients having formal CI or no stoma. This study also did not include patients with GI who required an anastomotic leak to mature after surgery.
The surgical procedure
Using a phantom ileostomy as an experimental intervention. Once the anastomosis is constructed and tested in the air, the terminal ileum, the last loop of the small bowel, will be found. The assigned ghost ileostomy site will have a mesenteric window made, and a silicone loop will be inserted through the window and around the small bowel. A serosal, non-absorbing suture will be used to mark the oral section of the ileum around 1-2 cm proximally to the silicone loop for proper bowel orientation in their host ileostomy to be exteriorized. In ordain the colon below the abdominal fascia without any stress, the silicone loop will be exteriorized at the preoperatively indicated, designated ileostomy position through a stab incision and attached to the skin using a rod and non-absorbing sutures. The abdominal cavity will then be sutured along with the exteriorized silicone loop and all incisions, including the midline and laparoscopic incisions, and covered with sterile dressings. Figure 1 shows a schematic example of a ghost ileostomy,
schematic representation of a ghost ileostomy. In (A), the silicone loop is carried around the terminal ileum, and in (B), the silicone loop is exteriorized, leaving the terminal ileum naturally intra-abdominal.
Before the silicone loop was removed on postoperative day six, Figure 2 shows a photograph of a patient who had a ghost ileostomy.
For any indication of anastomotic leakage, patients will be closely observed. Signs of anastomotic leakage can be palpated or detected radiologically. Other clinical and laboratory signs include fever, abdominal guarding, peritonism, air/fecal/turbid discharge from the intra-abdominal drains, leucocytosis, or elevated C reactive protein values that indicate a deviation from the expected postoperative course. An operating room procedure will be performed under general anesthesia to exteriorize the ghost ileostomy in a patient if anastomotic leakage is suspected. A long cylinder of skin and subcutaneous tissue will be removed next to the silicone loop, just like with a traditional ileostomy. Like a traditional ileostomy, the ventral and dorsal sheaths of the abdominal fascia will be cut, and the terminal ileum will be exteriorized by gently pulling on the silicone loop. Using circular everting sutures in the standard manner—that is, without causing torsion on the mesentery or bowel—the proximal segment of the small bowel will be identified by the serosal suture that was placed during primary surgery. If feasible, the oral ileal limb will be placed caudally to create the stoma in the correct orientation. The last step will be to implant an ileostomy bag.
By the standard clinical judgments of the treating physicians and the clinical course of any patient with suspected anastomotic leakage, additional diagnostic (proctoscopy, CT scan) or treatments (interventional drainage) will be carried out.
At the bedside on postoperative days 5–10, the silicone loop will be withdrawn if there are no indications of anastomotic leakage following ghost ileostomy, the patient has regular bowel movements, and they are fed exclusively through oral syringes.
Load ileostomy as a control measure The final loop of the small intestine, or terminal ileum, will be identified in the same way as in the experimental group following anastomosis creation and air testing. Around the small bowel, a silicone loop will be passed through the mesenteric window that has been established at the appropriate ileostomy loop. Skin and subcutaneous tissue will be removed in the form of a longitudinal cylinder for conventional ileostomies. A cut that allows two fingers to easily pass through the opening will be made in the ventral and dorsal sheaths of the abdominal fascia. Next, exteriorization of the ileal loop will occur. The ileal limb of the oral cavity will be positioned caudally, if feasible, and the stoma will be constructed in the proper orientation using circular everting sutures in the conventional method, meaning that there will be no torsion on the gut or mesentery. The last step will be to implant an ileostomy bag.
Complementary therapies and approved or prohibited therapies
Parenteral feeding, antimicrobial therapy, and relaparotomy are a few examples of concurrent or essential treatments that will be carried out at the treating physicians' discretion and by regional norms.
Trial endpoints and data gathering
For each patient, the following demographic and baseline data will be recorded: Age (years), gender (male/female), height (cm), weight (kg), class of the American Society of Anesthesiologists, histologically proven carcinoma (yes/no), bowel obstruction (yes/no), rectal bleeding/anemia (yes/no), level of tumor resection high or low resection, neoadjuvant therapy (yes/no), and relevant medical history (cardiac, pulmonary, renal, hepatic, diabetes) as well as previous imaging studies (CT/MRI/endoscopic ultrasound).
After confirming that the intraoperative exclusion criteria have been met, the following information will be collected during the procedure: the length of time (in minutes), the surgeon's experience (> or ≤50 low anterior or high resections prior ), the amount of blood lost during the procedure (in milliliters), whether or not intraoperative blood transfusions are performed, and the quantity of packed red blood cells.
In this experiment, the Comprehensive Complication Index (CCI) will be the primary outcome measure. Per the established Clavien-Dindo classification, the CCI provides an individual patient-level summary of all postoperative complications based on their severity grade. The complications range from mild ones that do not deviate from the normal clinical course (grade I) to postoperative death (grade V) [22]. The first hospital stay as well as the first three and six months following surgery will be used in calculating the CCI. AlsoFollowing surgery, patients need to be closely observed in a clinical setting, with particular attention paid to the patient's pulse, blood pressure, breathing rate, temperature, abdominal distension or pain, and drain contents. Every patient should have a full blood count and a C-reactive protein assay sent on the third postoperative day (POD) to screen for sepsis or, more indirectly, AL. Limited-contrast radiography is frequently carried out postoperatively. On the fifth and seventh postpartum days, abdominal and pelvic ultrasonography is performed to rule out any collections in the abdomen or pelvis. After administering water-soluble contrast directly above the anal canal, a contrast X-ray of the pelvis might be performed if any collection is observed to rule out any major contrast leak at the anastomotic location. An abdomen and pelvic CT scan should be done if the X-ray shows substantial AL
Reexamination.
terminal ostomy, such as abdominoperineal extirpation or Hartmann's technique.
The term "intra-abdominal abscess" refers to the collection of purulent or infected fluid within the abdomen (positive microbiological culture), which can be seen during surgical reintervention, interventional drainage, or typical radiographic abnormalities (such as a CT scan).
drainage by intervention.
The intended adjuvant or perioperative chemotherapy has been finished.
Patients six months post-initial surgery with stomas (terminal or loop)
difficulties arising from stomas...
Erythema, cutaneous excoriation, induration, putrid collection, and/or wound, abscess, or ulceration near the ileostomy that causes pain, burning, and trouble placing the ileostomy bag are all considered peristomal wound conditions.
hernia posteriore.
Clinical symptoms of dehydration and/or impaired kidney function combined with an ileostomy output of over 1500 mL per day necessitate the replacement of fluids through intravenous means.
As per the KDIGO definition, acute renal damage [24].
extra difficulties connected to the stoma.
after ileostomy closure complications.
leaks from anastomosis.
More than one of the following characteristics can indicate a prolonged postoperative ileus:
vomiting or nausea.
over the previous 24 hours, an inability to handle an oral diet
For the past 24 hours, there has been no flatus or stool.
abdominal distension.
via the use of radiography.
breaking of the wound.
Centers for Disease Control and Prevention: surgical site infection, [25]
belly rupture (abdominal fascia dehiscence).
hernia incisional.
and 6 years following surgery 27, 28,
Getting By.
Trial visit descriptions and patient schedules
In-hospital admission day, or outpatient consultation, is when patients scheduled for elective LAR/TME will be screened. The aforementioned baseline data will be evaluated and recorded following a patient's written informed consent and the screening appointment, which validate that the patient meets all eligibility requirements.
upon the authorization of staff (visit 2), randomization will take place during surgery upon verification of intraoperative eligibility conditions. The intraoperative parameters that were discussed will be evaluated on this appointment. Patients are monitored for six months following LAR/TME, with follow-up appointments set for postoperative days three and seven (visits three and four), 14/day of discharge (visit five), as well as one, three, and six months after surgery (visits six, seven, and eight). sessions 7-8 will take place over the phone or as part of follow-up outpatient sessions. Endpoints, both primary and secondary, are evaluated and recorded at postoperative visits. Additional evaluation and documentation will be done for therapeutic and diagnostic procedures brought on by surgical problems.
Figure 1 An instance of the phantom ileostomy schematically The terminal ileum is wrapped in a silicone loop in option (A) or exteriorized in option (B), leaving the terminal ileum tension-free intra-abdominal[20]..
Figure 2 Before the silicone loop was removed on the sixth surgical day, this patient had a ghost ileostomy.
The technique of Release Down of Ghost Ileostomy
All carcinoma rectum patients in this study underwent TME resection (LAR/uLAR) with an adequate circumferential resection margin (CRM), distal and proximal margins followed by colorectal/coloanal end-to-end or end-to-side anastomosis using the circular staplers or hand sewn techniques. After completion of the anastomosis, a protective GI was fashioned. In restorative rectal resections, this process averts the necessity and complications of formal CI in > 80% of patients with carcinomas.
However, the GI needs to be released before patients are discharged after surgery. Typically, a 10 to 12 Fr Ryle tube or Foley catheter is used to secure the GI loop. The removal of this hanging Ryle tube loop (or any other hanging material) from the abdominal cavity to release the tucked ileal loop is referred to as the 'release down' of the GI. In this regard, it is necessary to ascertain that the patient had no anastomotic leak (AL) before performing the GIRD. After confirming by clinical and radiological assessments that there is no AL, the tubing needs to be removed from the abdominal cavity (Figs. 3 and 4 Keep the patient in a supine position on their bed in the postoperative ward.
Care is taken to maintain privacy by uncovering the area of the GI (usually the right iliac fossa region).
Gain the patient's confidence in the procedure by providing reassurance, explaining the procedure to them, and seeking consent to proceed.
After donning the sterile surgical gloves, apply betadine paint on the GI tubing and the skin around it . There was no need to use any local anesthetic.
Cut the fixing suture of the GI tube to free it from the surrounding skin
Slightly pull both limbs of the tubing (Fig. 5) and cut one limb deeper into the skin with scissors. The other end of the tubing was gently pulled from the abdominal cavity to release the already-tucked ileal loop and).
Clean the wound area and apply a small antiseptic dressing (Fig. 6). At the end of the procedure, the patient was reassured and congratulated to be free from the misery and morbidities of the formal covering stoma.
after ensuring that there are no complications and bowel movements are normal.:
Figure 3
Final external appearance of ghost ileostomy.
Figure 4
Final internal appearance of ghost ileostomy.
Figure 5
Cut one limb of tubing with scissors
Figure 6
Ghost Ileostomy tubing completely pulled out of the abdominal cavity
Following the procedure, patients were monitored in the outpatient department weekly at first, then every two weeks for a month, to check for any problems, morbidity, and death.
Analytical Statistics
After compiling and statistically analyzing the data, conclusions were drawn from the findings of the analysis.