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Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy

Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy

The loop transverse colostomy is matured without torsion using a plastic retainer. The stoma protrudes 2-3 cm. The loop of the transverse colon is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.

Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy

The loop ileostomy is matured 25-30 cm from the ileocecal angle without torsion and without a retainer, so that stoma protrudes 2-3 cm. The loop of the ileum is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.

Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy

Rustem Aupov

The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

The investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the Ufa Republican Clinical Oncology Center from February 2023 to February 2024.

All patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. Patients are randomized into 2 groups in a 1:1 ratio. In the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. The stoma exit sites are marked in advance the day before the surgery. The bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. Standardized stoma creation techniques are used. The resected parts are collected through a separate access. Patients are followed up for 60 days after surgery.

The sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (CI) = 95%.). Considering possible losses during the study, the number of patients was increased to 130.

The investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of SSI (stoma site infections) compared to the loop colostomy group.

Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

Randomized Single Center Clinical Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy in Patients After Major Anterior Resections

the number of days from surgery to discharge

the number of days from surgery to stoma closure

the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag

the number of days from surgery to hospitalization for first chemotherapy

Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

Diverting loop ileostomy with rod

diverting loop ileostomy without rod

Lukas E Bruegger, MD

Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Background

For rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. Here liberal use of protective stomas is widely accepted. Fecal diversion by loop ostomy may also be performed after extended adhesiolysis with serosal lesions and risk of intestinal perforation, in patients with obstructing rectal tumours requiring neoadjuvant radio-chemotherapy or in patients with complex anorectal injuries or fistulas. Generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the loop ileostomy into the abdomen. Nevertheless, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of feces onto the skin may occur even with correct eversion of the afferent limb. Despite easier application of stoma bags and therefore reduced risk of skin irritation, none of these alternative techniques are established. In various non-randomized studies rodless loop ileostomies were described with an overall morbidity between 3 and 39%. However definition of morbidity varies significantly in these studies and randomised controlled trials are missing so far.

Objective

The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Methods

The study is designed as multi-institutional, randomized controlled, two-armed study. Patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will be randomized to creation of a loop ileostomy with or without sustaining rod.

Diverting Loop Ileostomy: With or Without Rod

A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod

Measured in total hours from the intervention up to 3 months postoperatively

Insel Gruppe AG, University Hospital Bern

Lukas Bruegger MD

Anastomotic Leak

After LAR, the experimental group accepted controllable tube ileostomy.

After LAR, the experimental group accepted loop ileostomy.

Low anterior resection

tube ileostomy

loop ileostomy

accept reversal operation

remove the tube ileostomy

Hua Hanju, Doctor

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.

In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.

After low anterior resection(LAR), a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall. The investigators will test the pressure of airbag, and control the pressure of airbag from 30-40cmHg. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.

In the CTI group, the tube will be removed after 3-4 weeks. If anastomotic leakage occurred, the investigators will test the airbag pressure and keep the pressure during 30-40cmHg. Because with time went on, the ileum will dilated , the airbag pressure will go down, then the feces may go through the airbag plane and flow into colon and the tube ileostomy will lose its defunctioning effect.When the investigators control the airbag pressure, we can control the defunctioning effect of tube stomy. So it is called controllable tube ileostomy. The investigators will keep the tube until the anastomotic leakage was cured.

Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer

Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.

In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.

Anastomotic leakage(AL) is the main complication after LAR.AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomotic site (including suture and staple lines of the neorectal reservoirs) leading to communication between intra- and extraluminal compartments.

When AL occurred, whether this patient need reoperation is determined by the clinical manifestation. Reoperation rate and mortality are two key index to evaluate the effect and safety of cannula ileostomy.

Another main operation complication was intestinal obstruction. Ileus conclude two types: temporally ileus and intractable ileus. Temporally ileus can be treated by conservative treatment and intractable ileus need reoperation.Ileus usually is caused by intestinal adhesion. But in CTI group, ileus maybe caused by the cannula obstruction.

including operation method, time, blood loss et al.

First Affiliated Hospital of Zhejiang University

Doctor

Patients whose ileostomy have been closed after laparoscopic low anterior resection

Patients whose ileostomy have not been closed due to some problems

The risk factors for stoma reversal failure have been rarely studied, which is probably one of the worst scenarios for a case who has a sphincter preserving procedure for a rectal cancer and is expecting to have regular bowel movements through a functional anus. Several studies have analyzed this particular issue and some have shown that up to 30% of 'temporary' stomas have never been closed. However these data have been criticized to be heterogeneous, since they have included patients with benign and malignant diseases, cases underwent elective or emergent anterior or low anterior resections or restorative proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some studies have underlined some risk factors for the failure of stoma reversal, but they also have similar limitations as mentioned above. Finally, survival -to the best of investigators' knowledge- has never been separately studied in patients who cannot receive a stoma reversal procedure. Thus, current study aims to present a single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to expose the fortune of these cases.

Defunctioning stomas are commonly formed in order to divert the bowel stream mostly in case of distal anastomosis, particularly after a low anterior resection. It has been reported that a temporary ileostomy may decrease the risk of an anastomotic leak, which is a lethal complication. In addition, in case of an anastomotic leak, stomas may limit the septic sequence and may help the diseased anastomosis to heal or the area of inflammation to resolve. Stomas have been also shown to decrease the necessity of an urgent reoperation due to septic intra-abdominal complications that may occur after an anastomotic leak. Many believe that stoma complications are generally easily managed and reversal of stomas are associated with limited morbidity. Thus, selective or routine creation of diverting stomas have been recommended in patients underwent a low anterior resection.

The risk factors for stoma reversal failure have been rarely studied, which is probably one of the worst scenarios for a case who has a sphincter preserving procedure for a rectal cancer and is expecting to have regular bowel movements through a functional anus. Several studies have analyzed this particular issue and some have shown that up to 30% of 'temporary' stomas have never been closed. However these data have been criticized to be heterogeneous, since they have included patients with benign and malignant diseases, cases underwent elective or emergent anterior or low anterior resections or restorative proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some studies have underlined some risk factors for the failure of stoma reversal, but they also have similar limitations as mentioned above. Finally, survival -to the best of investigators' knowledge- has never been separately studied in patients who cannot receive a stoma reversal procedure. Thus, current study aims to present a single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to expose the fortune of these cases.

Fortune of Temporary Ileostomies in Patients After Rectal Cancer Surgery

Fortune of Temporary Ileostomies in Patients Treated With Laparoscopic Low Anterior Resection for Rectal Cancer

not only 30-day but all in-hospital complications including readmissions

the time from the primary operation {laparoscopic low anterior resection} to death from any cause

Dr. Lutfi Kirdar Kartal Training and Research Hospital

After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description.

After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons.

cannula ileostomy

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing anterior resections. Although debate about the use of defunctioning stoma continues, meta-analyses and randomized multicenter trial results support the use of defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to evaluate the efficacy and safety of a new diversion method called spontaneously closed cannula ileostomy (SCCI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.

After low anterior resection(LAR), in the LI group, the operation method was done as surgeons all known. In the cannula ileostomy group, a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall began to turn pale. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.

In the LI group, patients accepted reversal operation at least 3 months after operation if operation condition permission.

In the cannula ileostomy group, the cannula will be removed after 3-4 weeks. If anastomotic leakage occurred, The investigators will keep the cannula until the anastomotic leakage was cured.

Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer

Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer.

Anastomotic leakage(AL) is the main complication after LAR.AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomotic site (including suture and staple lines of the neorectal reservoirs) leading to communication between intra- and extraluminal compartments. When AL occurred, whether this patient need reoperation is determined by the clinical manifestation. Reoperation rate and mortality are two key index to evaluate the effect and safety of cannula ileostomy.

Another main operation complication was intestinal obstruction. Ileus conclude two types: temporally ileus and intractable ileus. Temporally ileus can be treated by conservative treatment and intractable ileus need reoperation.Ileus usually is caused by intestinal adhesion. But in cannula ileostomy group, ileus maybe caused by the cannula obstruction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy	NCT05745909	Rectal Neoplasm... Ostomy Neoplasms	Laparoscopic or... Laparoscopic or...	18 Years - 79 Years	Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
Diverting Loop Ileostomy: With or Without Rod	NCT00959738	Ileostomy Rectal Neoplasm...	Diverting loop ... diverting loop ...	18 Years -	Insel Gruppe AG, University Hospital Bern
Diverting Loop Ileostomy: With or Without Rod	NCT00959738	Ileostomy Rectal Neoplasm...	Diverting loop ... diverting loop ...	18 Years -	Insel Gruppe AG, University Hospital Bern
Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer	NCT02012023	Rectal Neoplasm... Low Anterior Re...	Low anterior re... tube ileostomy loop ileostomy accept reversal... remove the tube...	-	First Affiliated Hospital of Zhejiang University
Diverting Loop Ileostomy: With or Without Rod	NCT00959738	Ileostomy Rectal Neoplasm...	Diverting loop ... diverting loop ...	18 Years -	Insel Gruppe AG, University Hospital Bern
Fortune of Temporary Ileostomies in Patients After Rectal Cancer Surgery	NCT02532478	Loop Ileostomy		-	Dr. Lutfi Kirdar Kartal Training and Research Hospital
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer	NCT01980238	Rectal Neoplasm...	cannula ileosto... loop ileostomy LAR	-	First Affiliated Hospital of Zhejiang University

Spots Global Cancer Trial Database for loop ileostomy